Postherpetic Neuralgia: Current Evidence on the Topical Film-Forming Spray with Bupivacaine Hydrochloride and a Review of Available Treatment Strategies.

PURPOSE OF REVIEW: This is a comprehensive review of the literature about the use of bupivacaine hydrochloride for the treatment of post-herpetic neuralgia (PHN). It briefly reviews the background, biology, diagnosis and conventional treatment for PHN, and then introduces and compares the recent evidence for the use of topical bupivacaine. RECENT FINDINGS: PHN is defined by pain lasting 90 days or more after the initial presentation of herpes zoster ("Shingles", HZ) rash and is the most common complication of this disease. A product of re-activation of the Varicella-Zoster virus (VZV), HZ is diagnosed more than 1 million times annually in the United States. Approximately 20% of patients with HZ will experience PHN and will continue to suffer intermittent neuropathic symptoms, including itching and pain, that is sharp, stabbing, throbbing or burning, with the pain localized to the site of their original rash. This long-lasting pain compares with the severity of long-standing rheumatics and osteo-arthritis and is accompanied by severe allodynia causing significant suffering, and a financial burden that is manifested in both healthcare costs and loss of quality-adjusted life years. Prevention of PHN may be achieved with the Zoster vaccine, although there is still a large segment of unvaccinated population. Moreover, the Zoster vaccine is not always effective for prevention. Current treatment includes medical (systemic tricyclic antidepressants, anticonvulsants and opioids, topical lidocaine and capsaicin) and interventional (subcutaneous Botox injections, nerve blocks and nerve stimulation) therapies. These therapies are not always effective, and each carries their own profile of side effects and risks. Moreover, up to 50% of patients with PHN are refractory to management. Recent evidence is emerging to support the use of topical local anesthetics for the treatment of PHN. Two small studies recently found topical lidocaine spray to be effective in treating paroxysmal pain attacks associated with PHN. Bupivacaine is a longer-lasting local anesthetic, and a film-forming formulation allows easy and durable application to the affected skin. Recent studies show that topical film-forming bupivacaine is safe and as effective as lidocaine for the treatment of PHN. PHN is an important though common complication of HZ and can cause long-lasting pain and disability. Current treatment for PNH is limited by efficacy and safety profiles of individual therapies. Recent evidence points to topical local anesthetics as an effective and safe alternative to conventional therapy. Film-forming bupivacaine may offer a durable and safe option for this otherwise difficult to treat syndrome.

A Double-Blind, Randomized Controlled Trial of Pre-incision Wound Infiltration Using Diclofenac Versus Bupivacaine for Post-operative Pain Relief in Open Thyroid and Parathyroid Surgery.

BACKGROUND: Pre-incision wound infiltration using NSAID is an alternative method to manage post-operative pain in surgery. It is postulated that NSAID delivered peripherally exerts efficient analgesic and anti-inflammatory effect with minimal systemic complication. This study explored the efficacy of using diclofenac for wound infiltration in open thyroidectomy and parathyroidectomy as compared to conventional agent, bupivacaine. METHODOLOGY: The study was designed as a double-blind, randomized controlled trial involving 94 patients who underwent open thyroidectomy or parathyroidectomy in Hospital Pulau Pinang, Malaysia, from November 2015 to November 2016. The study compared the efficacy of pre-incision wound infiltration of diclofenac (n = 47) versus bupivacaine (n = 47) in post-operative pain relief. Wound infiltration is given prior to skin incision. Mean pain score at designated time interval within the 24-h post-operative period, time to first analgesia, total analgesic usage and total analgesic cost were assessed. RESULTS: Ninety-four patients were recruited with no dropouts. Mean age was 49.3 (SD = 14.2) with majority being female (74.5%). Ethnic distribution recorded 42.6% Chinese, 38.3% Malay, followed by 19.1% Indian. Mean duration of surgery was 123.8 min (SD = 56.5), and mean length of hospital stay was 4.7 days (SD = 1.8). The characteristics of patient in both groups were generally comparable except that there were more cases of total thyroidectomy in the diclofenac group (n = 31) as compared to the bupivacaine group (n = 16). Mean pain score peaked at immediate post-operative period (post-operative 0.5 h) with a score of 3.5 out of 10 and the level decreased steadily over the next 20 h starting from 4 h post-operatively. Pre-incision wound infiltration using diclofenac had better pain control as compared to bupivacaine at all time interval assessed. In the resting state, the mean post-operative pain score difference was statistically significant at 2 h [2.1 (SD = 1.5) vs. 2.8 (SD = 1.8), p = 0.04]. During neck movement, the dynamic pain score difference was statistically significant at post-operative 1 h [2.7 (SD = 1.9) vs. 3.7 (SD = 2.1), p = 0.02]; 2 h [2.7 (SD = 1.6) vs. 3.7 (SD = 2.0), p = 0.01]; 4 h [2.2 (SD = 1.5) vs. 2.9 (SD = 1.7), p = 0.04], 6 h [1.9 (SD = 1.4) vs. 2.5 (SD = 1.6), p = 0.04] and 12 h [1.5 (SD = 1.5) vs. 2.2 (SD = 1.4), p = 0.03]. Mean dose of tramadol used as rescue analgesia in 24 h duration was lower in the diclofenac group as compared to bupivacaine group [13.8 mg (SD = 24.9) vs. 36.2 mg (SD = 45.1), p = 0.01]. The total cost of analgesia used was significantly cheaper in diclofenac group as compared to bupivacaine group [RM 3.47 (SD = 1.51) vs. RM 13.43 (SD = 1.68), p < 0.01] or [USD 0.83 (SD = 0.36) vs. USD 3.21 (SD = 0.40), p < 0.01]. CONCLUSION: Pre-incision wound infiltration using diclofenac provides better post-operative pain relief compared to bupivacaine for patient who had underwent open thyroidectomy or parathyroidectomy. Diclofenac is cheap and easily available in the limited resource setting. This approach offers a superior alternative for post-operative pain relief as compared to bupivacaine.

Study of Peri-Articular Anaesthetic for Replacement of the Knee (SPAARK): study protocol for a patient-blinded, randomised controlled superiority trial of liposomal bupivacaine.

BACKGROUND: Optimising the management of peri-operative pain and recovery following knee replacement has been identified as a patient priority. Current pain relief strategies use opiate-based analgesia; however, up to 50% of patients experience significant side effects. Local anaesthetic incisional infiltration is one alternative. The length of the duration of action is a major limiting factor of current local anaesthetic techniques. Liposomal bupivacaine has been reported to be effective for up to 72 h. This randomised controlled trial will evaluate the clinical and cost effectiveness of liposomal bupivacaine. METHODS: SPAARK is a patient-blinded, multi-centre, active comparator, superiority, two-arm, parallel-group randomised controlled trial. Five hundred patients undergoing knee replacement will be recruited and randomised to liposomal bupivacaine plus bupivacaine hydrochloride or bupivacaine hydrochloride alone. The co-primary outcomes are the Quality of Recovery 40 measured at 72 h post-surgery and also cumulative pain measured daily using a 0-10 visual analogue scale for the first 3 days following surgery. Secondary outcomes include cumulative opioid consumption, fitness for discharge, functional outcomes assessed using the Oxford Knee Score and American Knee Society Score, the EuroQol five dimensions instrument and complications. A cost utility analysis is also planned. DISCUSSION: The clinical effectiveness and cost effectiveness of liposomal bupivacaine have yet to be evaluated in the National Health Service, making this trial appropriate and timely. TRIAL REGISTRATION: ISRCTN registry, ISRCTN54191675. Registered on 14 November 2017.

Impact of liposomal bupivacaine on opioid use, hospital length of stay, discharge status, and hospitalization costs in patients undergoing total hip arthroplasty.

Aims: Effective postsurgical analgesia hastens recovery, reduces hospital length of stay (LOS), and decreases hospitalization costs for total hip arthroplasty (THA). Improving these outcomes is critical for value-based surgical bundled payment programs such as the Medicare Comprehensive Care for Joint Replacement and similar programs for commercial insurance providers. This study compared clinical outcomes and hospitalization costs for patients undergoing THA with and without liposomal bupivacaine (LB).Materials and methods: This retrospective, comparative cohort study used data from the Premier Healthcare Database from the 10 hospitals with highest use of LB for THA from January 2011 through April 2017. A cohort undergoing THA with LB at those hospitals was compared with a propensity-score matched cohort at those hospitals who had THA without LB. Descriptive, univariate, and multivariable analyses compared post-surgical inpatient opioid consumption, hospital LOS, discharge status, same-hospital readmissions, and total hospitalization costs. Analyses were performed using the Pearson Chi-square test (categorical variables) and Wilcoxon or Student t-test (continuous variables).Results: For patients with Medicare (with LB, n = 3622; without LB, n = 3610) and commercial insurance (with LB, n = 2648; without LB, n = 2709), use of LB was associated with lower post-surgical inpatient opioid consumption (105 and 81 mg, respectively; p < 0.0001), a 0.7-day shorter LOS (p < 0.0001), a 1.6-1.7-fold increased likelihood of home discharge (p < 0.0001), and no increase in readmissions (p ≥ 0.103). Total hospitalization costs were $561 lower with LB in the Medicare population (p < 0.0001) and $41 higher with LB in the commercial population (p = 0.7697).Limitations: Hospitalization costs were estimated from the hospital chargemaster. Findings from these 10 hospitals may not represent other US hospitals.Conclusions: At select hospitals, THA with LB was associated with reduced post-surgical inpatient opioid consumption, shorter hospital LOS, increased likelihood of home discharge, and lower hospitalization costs. Post-surgical pain management with LB may help hospitals in value-based bundled payment programs.

ECONOMIC EFFECTIVENESS OF DIFFERENT METHODS OF ANESTHESIA OF CURETTAGE OF UTERINE CAVITY.

Anesthesia of curettage of uterine cavity (CUC) at postoperative period causes additional expenses. Preventive intraoperative anesthesia makes it possible to reduce these expenses and provide significant positive economic effect on state budget. The objective of this research is determination of influence of different methods of anesthesia of CUC on cash value of anesthetic maintenance of CUC and the possibility of saving of budgetary funds. 128 women took part in the research. They underwent the procedure of CUC. Anesthetic maintenance was performed using different medicamental combinations and their dosages. Mathematical calculation of the cost of each CUC stage was done considering the cost of consumables, medical preparations and value of labor of medical staff. In the course of this research, it was proven that a combination of additional use of dexketoprofen (at the stage of premedication of CUC) and performing preventive intraoperative applicational anesthesia with bupivacaine solution can save 130 452,26UAH of wage fund per year and general budget savings within the confines of a state can each 9 954 617,67UAH per year.

A Cost-Minimization Analysis Evaluating the Use of Liposomal Bupivacaine in Reconstructive Plastic Surgery Procedures.

BACKGROUND: Postsurgical pain management is critical to patient satisfaction and value. Several studies have evaluated liposomal bupivacaine in postoperative pain management protocols; however, its economic feasibility remains undefined. This study analyzes the economic impact of liposomal bupivacaine using a national claims database to assess postoperative clinical and financial outcomes in plastic and reconstructive procedures. METHODS: The Vizient Clinical Data Base/Resource Manager electronic database was reviewed for plastic surgery procedures (i.e., abdominoplasty, abdominal wall reconstruction, mastectomy with immediate tissue expander placement, mastectomy with direct-to-implant reconstruction, autologous breast reconstruction, and augmentation mammaplasty) at participating hospitals from July 1, 2016, to July 1, 2017. The main outcome measures were the length of stay; 7-, 14-, and 30-day readmission rates; and direct and total costs observed. RESULTS: During the study period, 958 total cases met inclusion criteria. Liposomal bupivacaine was used in 239 cases (25 percent). Compared with cases that did not use liposomal bupivacaine, liposomal bupivacaine cases had a decreased length of stay (9.2 days versus 5.8 days), decreased cost (total cost, $39,531 versus $28,021; direct cost, $23,960 versus $17,561), and lower 30-day readmission rates (4 percent versus 0 percent). The 14- and 7-day readmission rates were similar between the two groups. CONCLUSIONS: The use of liposomal bupivacaine may contribute to a reduction in length of stay, hospital costs, and 30-day readmission rates for abdominal and breast reconstructive procedures, which could contribute to a favorable economic profile from a system view. Focusing on the measurement and improvement of value in the context of whole, definable, patient processes will be important as we transition to value-based payments.

Impact of treatment with liposomal bupivacaine on hospital costs, length of stay, and discharge status in patients undergoing total knee arthroplasty at high-use institutions.

Aims: Post-surgical pain experienced by patients undergoing total knee arthroplasty (TKA) can be severe. Enhanced recovery after surgery programs incorporating multimodal analgesic regimens have evolved in an attempt to improve patient care while lowering overall costs. This study examined clinical and economic outcomes in hospitals using liposomal bupivacaine (LB) for pain control following TKA.Methods: This retrospective observational study utilized hospital chargemaster data from the Premier Healthcare Database from January 2011 through April 2017 for the 10 hospitals with the highest number of primary TKA procedures using LB. Within these hospitals, patients undergoing TKA who received LB were propensity-score matched in a 1:1 ratio to a control group not receiving LB. Outcomes included hospital length of stay (LOS), discharge status, 30-day same-hospital readmissions, total hospitalization costs, and opioid consumption; only patients with Medicare or commercial insurance as the primary payer for TKA were considered.Results: The study population included 20,907 Medicare-insured patients (LB = 10,411; control =10,496) and 12,505 patients with commercial insurance (LB = 6,242; control = 6,263). Overall, LOS was 0.6 days shorter with LB (p < 0.0001), and patients who received LB were 1.6-times more likely to be discharged home (p < 0.0001). Total hospitalization costs for the TKA procedure were lower with LB for patients with both Medicare (-$616; P < 0.0001) and commercial insurance (-$775; p < 0.0001). Opioid consumption was lower with LB in both payer populations (p < 0.0001). No significant differences for 30-day readmissions were found.Limitations: Costs were estimated using Premier charge-to-cost ratios and limited to goods and services recorded in the chargemaster. Findings from these 10 hospitals may not be representative of other US hospitals.Conclusions: In a sub-set of 10 US hospitals with the highest use of LB for TKA, LB use was associated with shorter hospital LOS, increased home discharge, lower total hospitalization costs, and decreased opioid use after TKA.

The cost-effectiveness of epidural, patient-controlled intravenous opioid analgesia, or transversus abdominis plane infiltration with liposomal bupivacaine for postoperative pain management.

STUDY OBJECTIVE: Intravenous patient-controlled opioid analgesia (IVPCA), epidural analgesia and transversus abdominis plane (TAP) infiltrations are frequently used postoperative pain management modalities. The aim of this study was to conduct a cost-effectiveness analysis comparing the use of epidural, IVPCA, and TAP infiltrations with liposomal bupivacaine for analgesia in the first 72 h postoperatively in patients undergoing major lower abdominal surgery. DESIGN: Retrospective cost effectiveness analysis. SETTING: Operating room. PATIENTS: We obtained data on major lower-abdominal surgeries performed under general anesthesia on adult patients between January 2012 and July 2014. INTERVENTIONS: A cost-effectiveness analysis was comparing the use of epidural, IVPCA, and TAP infiltrations with liposomal bupivacaine for analgesia in the first 72 h postoperatively. MEASUREMENTS: A decision analytic model was used to estimate the health outcomes for patients undergoing major lower abdominal surgery. The primary outcome was time-weighted pain from 0 to 72 h after surgery, as measured by numerical rating scale pain scores. The analysis was conducted from the perspective of the hospital as the party responsible for most costs related to surgery. MAIN RESULTS: From the base case analysis, IVPCA was the optimal strategy regarding cost and effect. TAP with LB, however, was only narrowly dominated, while epidural was clearly dominated. From the sensitivity analysis at willingness-to-pay (WTP) of $150, IV PCA and TAP infiltration were each the optimal strategy for approximately 50% of the iterations. At WTP of $10,000, epidural was only the optimal strategy in 10% of the iterations. CONCLUSIONS: This is the first study in the literature to compare the cost-effectiveness of epidural, IVPCA, and TAP infiltrations with LB. Within reasonable WTP values, there is little differentiation in cost-effectiveness between IVPCA and TAP infiltration with LB. Epidural does not become a cost-effective strategy even at much higher WTP values.

Liposomal bupivacaine mixture has similar pain relief and significantly fewer complications at less cost compared with indwelling interscalene catheter in total elbow arthroplasty.

BACKGROUND: Postoperative pain control, short-term and long-term narcotic consumption, complication rates, and costs of indwelling interscalene catheter (ISC) were compared with a liposomal bupivacaine (LBC) mixture in patients undergoing primary total elbow arthroplasty. METHODS: Forty-four consecutive patients were identified, the first 28 with an ISC and the later 16 with intraoperative LBC injection that also included ketorolac and 0.5% bupivacaine. Medical records were reviewed for visual analog scale scores for pain, oral morphine equivalent (OME) use, complications, and facility charges. RESULTS: Average visual analog scale scores at 24 hours, 2 weeks, 6 weeks, and 12 weeks were not significantly different. Mean OME use was significantly greater in the LBC group at 24 hours but less at 12 weeks, although this difference was not statistically significant. Twelve anesthetic-related complications occurred in the ISC group (1 major and 11 minor); 10 patients (36%) had at least 1 complication. The major complication was respiratory failure requiring emergent tracheostomy. Minor complications included leaking pump/catheters, catheters inadvertently pulled out early, global hand paresthesias, forearm paresthesias, and pain at the catheter site. There were no anesthetic-related complications in the LBC group. The average charge for the LBC mixture was $327.10; charges for ISC, including equipment and anesthesia fees, were $1472.42. CONCLUSIONS: An LBC mixture provides similar pain relief with fewer complications at a lower cost than indwelling ISC after total elbow arthroplasty. Although the OME use in the LBC group was almost double that of the ISC group at 24 hours, there was no difference at later time points.

Prospective, Randomized, Controlled Comparison of Bupivacaine versus Liposomal Bupivacaine for Pain Management after Unilateral Delayed Deep Inferior Epigastric Perforator Free Flap Reconstruction.

Effective postsurgical analgesia is a critical aspect of patient recovery. The goal of this prospective, randomized, controlled, blinded study was to examine the effect that liposomal bupivacaine delivered by means of a transversus abdominis plane block has on pain control in women undergoing unilateral deep inferior epigastric perforator flap reconstruction. Institutional review board approval was granted for this prospective study. Patients were eligible if they were undergoing unilateral, delayed deep inferior epigastric perforator flap reconstruction. Patients were randomized to one of three groups: liposomal bupivacaine transversus abdominis plane block, or bupivacaine pain pump. Charts were reviewed for demographics, length of stay, and postoperative narcotic use. There were eight patients in the liposomal bupivacaine and bupivacaine transversus abdominis plane block groups and five patients in the pain pump group. A retrospective cohort of six patients who did not receive any intervention was included. Patients who received a liposomal bupivacaine transversus abdominis plane block used statistically significantly less intravenous and total postoperative narcotics in milligrams and milligrams per kilogram per day compared with all other cohorts. They were able to get out of bed at an earlier time point. Overall hospital costs were similar among the groups. This is the first study to investigate liposomal bupivacaine delivered as a transversus abdominis plane block in a prospective, randomized, blinded study in women undergoing unilateral, delayed, abdominally based autologous breast reconstruction. The authors were able to demonstrate a significant reduction in intravenous and total narcotic use when a liposomal bupivacaine transversus abdominis plane block was used. Future studies are needed to prospectively investigate the effect that liposomal bupivacaine would have on immediate and bilateral reconstructions.

Impact of long-acting local anesthesia on clinical and financial outcomes in laparoscopic colorectal surgery.

BACKGROUND: Our objective was to assess clinical and financial outcomes with long-acting liposomal bupicavaine (LB) in laparoscopic colorectal surgery. METHODS: Patients that received local infiltration with LB were strictly matched to a control group, and compared for postoperative pain, opioid use, length of stay (LOS), hospital costs, and complication, readmission, and reoperation rates. RESULTS: A total of 70 patients were evaluated in each cohort. Operative times and conversion rates were similar. LB patients had lower post-anesthesia care unit pain scores (P = .001) and used less opioids through postoperative day 3 (day 0 P < .01; day 1 P = .03; day 2 P = .02; day 3 P < .01). Daily pain scores were comparable. LB had shorter LOS (mean 2.96 vs 3.93 days; P = .003) and trended toward lower readmission, complication, and reoperation rates. Total costs/patient were $746 less with LB, a savings of $52,200 across the cohort. CONCLUSIONS: Using local wound infiltration with LB, opioid use, LOS, and costs were improved after laparoscopic colorectal surgery. The additional medication cost was overshadowed by the overall cost benefits. Incorporating LB into a multimodal pain regiment had a benefit on patient outcomes and health care utilization.

Liposomal Bupivacaine Mixture Has Similar Pain Relief and Significantly Fewer Complications at Less Cost Compared to Indwelling Interscalene Catheter in Total Shoulder Arthroplasty.

BACKGROUND: The efficacy and costs of indwelling interscalene catheter (ISC) and liposomal bupivacaine (LBC), with and without adjunctive medications, in patients with primary shoulder arthroplasty are a source of current debate. METHODS: In 214 arthroplasties, 156 patients had ISC and 58 had LBC injections that were mixed with morphine, ketorolac, and 0.5% bupivacaine with epinephrine. Charts were reviewed for visual analog scale pain scores, oral morphine equivalent (OME) usage, major complications, and costs. RESULTS: Visual analog scale scores were not significantly different at 24 hours or at 2, 6, and 12 weeks. Average OME consumption at 24 hours was significantly more with LBC, but was not significantly different at 12 weeks. Relative risk of a major complication was nearly 4 times higher with ISC than with LBC. The average cost for the LBC mixture was $289.04, and for ISC, including equipment and anesthesia fees, was $1559.42. CONCLUSION: The intraoperative LBC mixture provided equivalent pain relief with significantly fewer major complications and at markedly lower cost than ISC. LBC required almost twice as much OME to attain the same level of pain relief at 24 hours, but there was no significant difference in the cumulative amount of outpatient narcotic use.

Efficacy of Liposomal Bupivacaine Infiltration on the Management of Total Knee Arthroplasty.

Importance: Liposomal bupivacaine is a novel extended-duration anesthetic that has recently been used for local infiltration in total knee arthroplasty (TKA). Athough liposomal bupivacaine is widely used, it is unknown if the benefits justify the cost in the veteran population at our institution. Objective: To evaluate a change in practice: the effect of local infiltration of liposomal bupivacaine on perioperative outcomes in patients undergoing primary TKA. Design, Setting, and Participants: A retrospective cohort study was conducted among patients who underwent primary TKA at a Veterans Affairs Medical Center before (March 3, 2013-March 2, 2014) and after (March 3, 2014-March 2, 2015) the implementation of liposomal bupivacaine for local infiltration in TKA. Intervention: Drug utilization evaluation of liposomal bupivacaine for local infiltration in TKA. Main Outcomes and Measures: Use of opioids after discharge from the postanesthesia care unit. Results: Among 199 patients, those who received liposomal bupivacaine after primary TKA (mean [SD] age, 65.3 [6.9] years; 93 males and 5 females) had a reduced median opioid use in the first 24 hours after surgery compared with those who did not receive liposomal bupivacaine (mean [SD] age, 64.9 [8.4] years; 95 males and 6 females; [intravenous morphine equivalents, 12.50 vs 22.50 mg; P = .001]). The use of patient-controlled analgesia was also reduced among patients who received liposomal bupivacaine vs those who did not (49 vs 91; P < .001). A reduction in the use of antiemetics was observed in the first 24 hours after surgery (13 vs 34; P = .001) and in the postanesthesia care unit among those who received liposomal bupivacaine vs those who did not (4 vs 20; P = .001). The number of patients in the postanesthesia care unit with no pain was improved among those who received liposomal bupivacaine vs those who did not (44 vs 19; P < .001). Although median (interquartile range) pain scores in the postanesthesia care unit were improved among patients who received liposomal bupivacaine vs those who did not (4.0 [0.0-6.6] vs 5.5 [3.0-7.5]; P = .001), patients who received liposomal bupivacaine had greater median (interquartile range) pain scores 48 hours (5.5 [4.0-7.0] vs 5.0 [3.0-6.0]; P = .01), 72 hours (5.0 [4.0-6.0] vs 4.0 [2.0-6.0]; P = .002), and 96 hours (5.0 [3.0-6.5] vs 4.0 [1.0-5.0]; P = .003) after surgery than those who did not receive liposomal bupivacaine. There was no difference in the median length of stay between the 2 groups. Institutional cost savings was estimated at $27 000 per year. Conclusions and Relevance: Local infiltration of liposomal bupivacaine reduces use of opioids in the first 24 hours after primary TKA. Similarly, reduction in antiemetic use and improved postoperative pain are also seen in the first 24 hours after surgery but are limited to this time frame. Furthermore, a positive institutional cost savings was observed.

Abdominal Incision Injection of Liposomal Bupivacaine and Opioid Use After Laparotomy for Gynecologic Malignancies.

OBJECTIVE: To investigate opioid use and pain scores associated with incisional injection of liposomal bupivacaine compared with bupivacaine hydrochloride after laparotomy for gynecologic malignancies. METHODS: A retrospective cohort study was conducted to compare abdominal incision infiltration with liposomal bupivacaine with bupivacaine hydrochloride after modification of a pre-existing enhanced recovery pathway. Patients undergoing staging laparotomy or complex cytoreductive surgery under the updated pathway were compared with patients treated under the original pathway (historic controls). Endpoints included cumulative opioid use (primary outcome) in oral morphine equivalents and cumulative pain score. RESULTS: In the complex cytoreductive cohort, median oral morphine equivalents were lower in the liposomal bupivacaine group through 24 hours (30 compared with 53.5 mg, P=.002), 48 hours (37.5 compared with 82.5 mg, P=.005), and the length of stay (62 compared with 100.5 mg, P=.006). Fewer liposomal bupivacaine patients required intravenous rescue opioids (28.9% compared with 55.6%, P<.001) or patient-controlled analgesia (4.1% compared with 33.3%, P<.001). Cumulative pain score was no different between groups through 48 hours (161 compared with 158, P=.69). Postoperative nausea and ileus were less frequent in patients receiving liposomal bupivacaine. Median hospital stay was 5 days in both groups. In the staging laparotomy cohort, cumulative opioids and cumulative pain score were no different between groups (through 48 hours: 162 compared with 161, P=.62; 38 compared with 38, P=.68, respectively). Intravenous rescue opioids (15.3% compared with 28.6%, P=.05) and patient-controlled analgesia (1.4% compared with 8.3%, P=.05) were used less frequently in the liposomal bupivacaine group. Median hospital stay was 4 days in both groups. Despite the higher cost of liposomal bupivacaine, total pharmacy costs did not differ between groups. CONCLUSION: Abdominal incision infiltration with liposomal bupivacaine was associated with less opioid and patient-controlled analgesia use with no change in pain scores compared with bupivacaine hydrochloride after complex cytoreductive surgery for gynecologic malignancies. Improvements were also seen in patients undergoing staging laparotomy.

Cost-benefit evaluation of liposomal bupivacaine in the management of patients undergoing total knee arthroplasty.

PURPOSE: Results of a cost-benefit analysis of intraoperative use of liposomal bupivacaine for postsurgical pain management in patients undergoing total knee arthroplasty (TKA) are presented. METHODS: In a retrospective single-site study, clinical and cost outcomes were compared in a group of 134 consecutive patients who received liposomal bupivacaine (by local infiltration) during TKA and a propensity score-matched historical cohort of 134 patients undergoing TKA who received usual care (continuous femoral nerve blockade with conventional bupivacaine delivered via elastomeric pump). RESULTS: Postsurgical pain scores and opioid use were similar in the two study groups; the mean total amount of nonsteroidal antiinflammatory drugs administered was lower in the liposomal bupivacaine group. Patients who received liposomal bupivacaine typically ambulated earlier than those who received usual care (22% and 3%, respectively, walked on the day of surgery; p < 0.05) and were more likely to be discharged within two days (50% versus 19%, p < 0.001); on average, liposomal bupivacaine- treated patients walked farther on the day of surgery (6.0 m versus 3.1 m, p < 0.001) and the day after surgery (63.7 m versus 25.5 m, p < 0.001) and had a shorter length of stay (LOS) (3.1 days versus 3.6 days, p < 0.03). The mean adjusted total direct hospital cost per patient was significantly lower with liposomal bupivacaine use versus usual care ($8758 versus $9213, p = 0.033). CONCLUSION: In patients undergoing TKA, intraoperative administration of liposomal bupivacaine for management of postsurgical pain was found to offer advantages over usual care, including decreased time to ambulation and reduced hospital LOS.

Cost-effectiveness analysis of levobupivacaine 0.5 %, a local anesthetic, infusion in the surgical wound after modified radical mastectomy.

BACKGROUND AND OBJECTIVE: Effective treatment of postoperative pain contributes to decreasing the rate of complications as well as the total cost of the operated patients. The aim of this study was to analyze the costs and the efficiency of use of continuous infusion of levobupivacaine 0.5 % with the help of an infusion pump in modified radical mastectomy. METHODS: A cost calculation of the analgesic procedures (continuous infusion of levobupivacaine 0.5 % [levobupivacaine group (LG)] or saline [saline group (SG)] (2 ml/h 48 h) has been carried out based on the data of a previous clinical trial (double-blind randomized study) of patients who underwent modified radical mastectomy surgery. The measure of the effectiveness was the point reduction of pain derived from the verbal numeric rating scale (VNRS). The usual incremental cost-effectiveness ratio (ICER) was performed. RESULTS: Considering only the intravenous analgesia, overall costs were lower in LG, as less analgesia was used (EUR14.06 ± 7.89 vs. 27.47 ± 14.79; p < 0.001). In this study the costs of the infusion pump were not calculated as it was used by both groups and they offset each other. However, if the infusion pump costs were included, costs would be higher in the LG, (EUR91.89 ± 7.89 vs. 27.47 ± 14.79; p < 0.001) and then the ICER was -8.51, meaning that for every extra point of decrease in the pain verbal numerical rating score over the 2-day period, the cost increased by EUR8.51. CONCLUSION: Infiltration of local anesthetics is an effective technique for controlling postoperative pain and the associated added costs are relatively low in relation to the total cost of mastectomy, therefore providing patients with a higher quality of care in the prevention of pain. CLINICAL TRIALS REGISTRATION: clinicaltrials.gov: reference number NCT01389934. http://clinicaltrials.gov/show/NCT01389934

Does Extended-Release Liposomal Bupivacaine Better Control Pain Than Bupivacaine After Total Knee Arthroplasty (TKA)? A Prospective, Randomized Clinical Trial.

Liposomal bupivacaine periarticular injection (PAI) offers sustained bupivacaine release after TKA, but few prospective independent studies exist. In this prospective, blinded study, liposomal bupivacaine was randomized against bupivacaine and incorporated into a comprehensive multimodal pain management protocol. 111 primary TKAs were randomized to receive PAI: 58 patients received 266 mg (20cc) liposomal bupivacaine mixed with 75 mg (30cc) 0.25% bupivacaine, and 53 patients received 150 mg (60cc) 0.25% bupivacaine. Visual analog pain scores and narcotic use were determined. No pain score differences occurred between study and control patients: Day 1: 4.5/4.6 (P=0.73); Day 2: 4.4/4.8 (P=0.27); or Day 3: 3.5/3.7 (P=0.58). Narcotic use was similar during hospitalization, 51.8/54.2 (P=0.34). The study medication costs $285, and the control medication costs $2.80. This finding does not justify the routine use of liposomal bupivacaine.

[Use of 2 % hyperbaric prilocaine for spinal anesthesia : sensitivity analysis in outpatient surgery]. / Einsatz von 2 %igem hyperbarem Prilocain zur Spinalanästhesie : Sensitivitätsanalyse in der ambulanten Chirurgie.

BACKGROUND: Hyperbaric prilocaine 2 % has been available for spinal anesthesia in Germany for 2 years and is characterized by a short duration of action, a lack of postspinal urine retention and a reduction of transient neurological syndromes. However, desirable pharmacological properties are contrasted by higher pharmacological costs compared to hyperbaric bupivacaine 0.5 %. MATERIALS AND METHODS: This paper deals with a sensitivity analysis for the use of hyperbaric prilocaine 2 % versus hyperbaric bupivacaine 0.5 % in Germany and investigates the financial break-even point up to which time a shorter patient stay in the recovery area compensates for the higher costs for the use of prilocaine 2 % for ambulatory spinal aaesthesia. A sensitivity analysis is an instrument of investment appraisal. It is a model to reduce a complex system with numerous variables to a straightforward calculation by assuming a framework requirement and systematically changing only one or two variables. In this paper additional costs for spinal anesthesia have been neglected, only the time a nurse spends with the patient in the recovery area and the costs for each vial of drug have been taken into account. RESULTS: For the assumption of 75 min time until leaving the recovery area and being discharged after spinal anesthesia with hyperbaric prilocaine 2 % versus 150 min (recovery of motor competence) or 405 min (voiding) with hyperbaric bupivacaine 0.5 % the calculation shows a cost benefit for hyperbaric prilocaine 2 % of EUR 11.64 or EUR 64.76 compared to hyperbaric bupivacaine 0.5 % and EUR 13.32 or EUR 66.44 compared to isobaric bupivacaine 0.5 %. Under the assumption that all patients who have received spinal anesthesia with hyperbaric bupivacaine 0.5 % can be discharged from the recovery area after 150 min, the use of hyperbaric prilocaine 2 % remains more economical as long as the patient is discharged from the recovery area within 130 min. If 405 min recovery time is assumed for hyperbaric bupivacaine 0.5 % the costs compared with hyperbaric prilocaine 2 % will be compensated after 300 min. To be more economical compared to patients with hyperbaric prilocaine 2 % those who received hyperbaric bupivacaine 0.5 % must be discharged from the recovery area within at least 100 min. However, a time of less than 160 min for discharge from the recovery area is not published anywhere in the literature. In summary, the use of hyperbaric prilocaine 2 % for 60 min operation time is cheaper than the use of bupivacaine 0.5 % as long as patients do not stay in the recovery area for longer than 120 min and are discharged from the recovery area. CONCLUSIONS: For German framework conditions the use of hyperbaric prilocaine 2 % can provide an economical advantage compared to the use of hyperbaric bupivacaine 0.5 % if staff assignment can be flexible.

The effect of local anaesthetic wound infiltration on chronic pain after lower limb joint replacement: a protocol for a double-blind randomised controlled trial.

BACKGROUND: For the majority of patients with osteoarthritis (OA), joint replacement is a successful intervention for relieving chronic joint pain. However, between 10-30% of patients continue to experience chronic pain after joint replacement. Evidence suggests that a risk factor for chronic pain after joint replacement is the severity of acute post-operative pain. The aim of this randomised controlled trial (RCT) is to determine if intra-operative local anaesthetic wound infiltration additional to a standard anaesthesia regimen can reduce the severity of joint pain at 12-months after total knee replacement (TKR) and total hip replacement (THR) for OA. METHODS: 300 TKR patients and 300 THR patients are being recruited into this single-centre double-blind RCT. Participants are recruited before surgery and randomised to either the standard care group or the intervention group. Participants and outcome assessors are blind to treatment allocation throughout the study. The intervention consists of an intra-operative local anaesthetic wound infiltration, consisting of 60 mls of 0.25% bupivacaine with 1 in 200,000 adrenaline. Participants are assessed on the first 5 days post-operative, and then at 3-months, 6-months and 12-months. The primary outcome is the WOMAC Pain Scale, a validated measure of joint pain at 12-months. Secondary outcomes include pain severity during the in-patient stay, post-operative nausea and vomiting, satisfaction with pain relief, length of hospital stay, joint pain and disability, pain sensitivity, complications and cost-effectiveness. A nested qualitative study within the RCT will examine the acceptability and feasibility of the intervention for both patients and healthcare professionals. DISCUSSION: Large-scale RCTs assessing the effectiveness of a surgical intervention are uncommon, particularly in orthopaedics. The results from this trial will inform evidence-based recommendations for both short-term and long-term pain management after lower limb joint replacement. If a local anaesthetic wound infiltration is found to be an effective and cost-effective intervention, implementation into clinical practice could improve long-term pain outcomes for patients undergoing lower limb joint replacement. TRIAL REGISTRATION: Current Controlled Trials ISRCTN96095682.