A phase 3 active-controlled trial of liposomal bupivacaine via sciatic nerve block in the popliteal fossa after bunionectomy.

STUDY OBJECTIVE: To investigate the efficacy, safety, pharmacodynamics, and pharmacokinetics of liposomal bupivacaine (LB) administered via ultrasound-guided sciatic nerve block in the popliteal fossa in participants undergoing bunionectomy. DESIGN: Two-part, randomized, double-blind, active-controlled trial (NCT05157841). SETTING: Operating room, postanesthesia care unit, and health care facility (6 sites). PATIENTS: Adults with American Society of Anesthesiologists physical status classification ≤3 and body mass index ≥18 to <40 kg/m2 undergoing elective distal metaphyseal osteotomy. INTERVENTIONS: Part A participants were randomized 1:1:1 to LB 266 mg, LB 133 mg, or bupivacaine hydrochloride 50 mg (BUPI). Part B participants were randomized 1:1 to LB (at the dose established by part A) or BUPI. MEASUREMENTS: The primary endpoint was area under the curve (AUC) of numerical rating scale (NRS) pain intensity scores 0-96 h after surgery. Secondary endpoints included total postsurgical opioid consumption, opioid-free status 0-96 h after surgery, and pharmacokinetic endpoints. MAIN RESULTS: Part A enrolled 22 participants per group. In part B, additional participants were randomized to LB 133 mg (n = 59) and BUPI (n = 60) (185 total). LB 133 mg had significant reductions versus BUPI in the AUC of NRS pain intensity score (least squares mean [LSM], 207.4 vs 371.4; P < 0.00001) and total opioid consumption 0-96 h after surgery (LSM, 17.7 [95% confidence interval (CI), 13.7, 22.8] morphine milligram equivalents [MMEs] vs 45.3 [95% CI, 35.1, 58.5] MMEs; P < 0.00001) and an increased proportion of opioid-free participants (24.4% vs 6%; odds ratio, 5.04 [95% CI, 2.01, 12.62]; P = 0.0003) in parts A + B. Adverse events were similar across groups. CONCLUSIONS: LB 133 mg administered via sciatic nerve block in the popliteal fossa after bunionectomy demonstrated superior and long-lasting postsurgical pain control versus BUPI. The clinical relevance of these findings is supported by concurrent reductions in pain and opioid consumption over 4 days after surgery and a significantly greater percentage of participants remaining opioid-free.

A practical guide to adopting Bayesian analyses in clinical research.

Background: Bayesian statistical approaches are extensively used in new statistical methods but have not been adopted at the same rate in clinical and translational (C&T) research. The goal of this paper is to accelerate the transition of new methods into practice by improving the C&T researcher's ability to gain confidence in interpreting and implementing Bayesian analyses. Methods: We developed a Bayesian data analysis plan and implemented that plan for a two-arm clinical trial comparing the effectiveness of a new opioid in reducing time to discharge from the post-operative anesthesia unit and nerve block usage in surgery. Through this application, we offer a brief tutorial on Bayesian methods and exhibit how to apply four Bayesian statistical packages from STATA, SAS, and RStan to conduct linear and logistic regression analyses in clinical research. Results: The analysis results in our application were robust to statistical package and consistent across a wide range of prior distributions. STATA was the most approachable package for linear regression but was more limited in the models that could be fitted and easily summarized. SAS and R offered more straightforward documentation and data management for the posteriors. They also offered direct programming of the likelihood making them more easily extendable to complex problems. Conclusion: Bayesian analysis is now accessible to a broad range of data analysts and should be considered in more C&T research analyses. This will allow C&T research teams the ability to adopt and interpret Bayesian methodology in more complex problems where Bayesian approaches are often needed.

Sublingual Sufentanil vs. Intravenous Fentanyl for the Treatment of Acute Postoperative Pain in the Ambulatory Surgery Center: A Randomized Clinical Trial.

Objectives: Sublingual sufentanil is a novel opioid medication to treat moderate to severe pain postoperatively. This study's aim was to determine if a single dose of a sublingual sufentanil tablet (SST) is as efficacious as a single dose of intravenous (IV) fentanyl in readiness to discharge from ambulatory surgery. Methods: This was a two-arm, parallel group, randomized prospective outcomes study conducted at a single, free-standing ambulatory surgery center. Patients aged 18-80 undergoing general anesthesia who developed a postoperative pain score of ≥ 4 were enrolled and randomized to receive either 30 mcg SST or 50 mcg IV fentanyl. After their initial randomized dose, rescue IV fentanyl followed by oral oxycodone if needed. Recovery length of stay from arrival in the postanesthesia care unit until readiness to discharge criteria was met based on phase 2 discharge criteria. Results: 75 patients were analyzed. Readiness to discharge from the recovery room was not significantly different between either group (IV fentanyl median 65 minutes; IQR 56-89; SST 73 min, IQR 58-89; p=0.903). There was no significant difference in the amount of morphine equivalents (MME) of rescue opioids needed (IV fentanyl median rescue MME of 22.5, IQR 13.1-23.4; SST median rescue MME of 15.0, IQR 7.5-30.0; p=0.742). The change in pain from PACU initially, and on discharge was not significantly different (IV fentanyl initial pain minus pain on discharge median 3, IQR 2-4; SST initial pain minus pain on discharge median 4, IQR 2-5.5; p=0.079). There was no difference in the six-item screener and the Overall Benefit of Analgesic Survey Score. Discussion. In conclusion, patients who received a sublingual sufentanil 30 mcg tablet had no significant differences in PACU length of stay or rescue analgesic usage when compared to intravenous fentanyl 50 mcg.

Comparing liposomal bupivacaine plus bupivacaine to bupivacaine alone in interscalene blocks for rotator cuff repair surgery: a randomized clinical trial.

BACKGROUND: Single-injection interscalene brachial plexus blocks are used for analgesia for rotator cuff repair (RCR) but have limited duration. The value of adding liposomal bupivacaine (LB) to prolong single-injection interscalene blocks is unclear. The purpose of this trial is to evaluate the addition of LB to regular bupivacaine interscalene blocks for patients undergoing arthroscopic RCR. METHODS: In this prospective, randomized trial, 70 patients undergoing primary RCR with equal group allocation were randomized by random number generator to receive an interscalene block with 20 mL of 0.5% bupivacaine or 10 mL 0.5% bupivacaine plus 133 mg LB. The primary outcome was cumulative opioid consumption within 72 hours of the procedure. Secondary outcomes included maximum pain scores and quality of recovery 15 survey scores. RESULTS: 70 of the 80 randomized patients were included in final analysis following exclusion for protocol violations and loss to follow-up. Cumulative opioid consumption (oral morphine equivalents) within 72 hours in patients receiving LB was a median (IQR) of 31.9 mg (0, 73.1) compared with 45.0 mg (15.0, 108.8) among patients receiving bupivacaine alone (p=0.312). Patients receiving LB demonstrated mixed results regarding worst pain scores with improvements at 24 hours and 72 hours, but not 48 hours. CONCLUSIONS: LB added to bupivacaine interscalene blocks does not reduce opioid consumption within 72 hours following arthroscopic RCR. TRIAL REGISTRATION NUMBER: NCT03587584.

Evaluation of Diaphragmatic Function after Interscalene Block with Liposomal Bupivacaine: A Randomized Controlled Trial.

BACKGROUND: Interscalene blocks provide analgesia for shoulder surgery but also cause phrenic nerve paralysis. Liposomal bupivacaine is approved for use in interscalene blocks with the potential to provide longer pain control. However, the impact of liposomal bupivacaine on the phrenic nerve has not been evaluated. It was hypothesized that patients who received an interscalene block with both bupivacaine and liposomal bupivacaine would have a decreased diaphragmatic excursion when compared to bupivacaine alone at 24 h. METHODS: This was a double-blinded study of adult patients who were randomized to receive an interscalene block with either 20 ml 0.5% bupivacaine (bupivacaine group) or 10 ml 0.5% bupivacaine plus 10 ml liposomal bupivacaine (liposomal bupivacaine group). Twenty-six patients were randomized with 22 included in the analysis. Diaphragmatic excursion (via ultrasound) and spirometry were assessed before the block, in the postanesthesia care unit, and at 24 h postblock. The primary outcome was diaphragm excursion with sigh. No adverse events were observed. RESULTS: At 24 h, the liposomal bupivacaine group median [25th, 75th], had a greater percent change in diaphragmatic excursion during sigh breath compared to the bupivacaine group, -24% [-30, -9] versus 9% [-8, 26], difference in location, 32 (95% CI, 12 to 52), P = 0.007. Five patients in the liposomal bupivacaine group had a greater than 25% reduction in diaphragmatic excursion at 24 h versus zero in the bupivacaine group. They also had a significantly greater percent reduction in forced expiratory volume in 1 s and forced vital capacity compared with the bupivacaine group at 24 h (median decrease of 22% vs. 2%, P = 0.006, and median decrease of 19% vs. 1%, P = 0.049, respectively). CONCLUSIONS: The addition of liposomal bupivacaine to bupivacaine in an interscalene block results in statistically significant reductions in diaphragm excursion and pulmonary function testing 24 h after block placement when compared to bupivacaine alone. This reduction, however, falls within the range of normal diaphragmatic function.

Patient Complications after Interscalene Block: A Retrospective Comparison of Liposomal Bupivacaine to Nonliposomal Bupivacaine.

BACKGROUND: The purpose of this study was to investigate if the addition of liposome bupivacaine (LB) to an interscalene block (ISB) had an effect on the number of patients with surgical- or block-related complications. METHODS: This was a single-center retrospective chart view performed by identifying patients who received an ISB from January 1, 2014, through April 26, 2018, at the University of Minnesota. 1,518 patients were identified who received an ISB (LB = 784, nonliposomal bupivacaine = 734). Patients were divided into two groups those who did receive liposome bupivacaine in their ISB and those who did not receive liposome bupivacaine in their ISB. Medical records were individually reviewed for surgical procedure, block medications, complications related to the block or surgical procedure, phone calls to the healthcare system for issues related to opioids or pain within 3 and within 30 days, readmissions within 30 days, and emergency room visits for complications within 3 and 30 days. RESULTS: There was no significant difference in the number of patients with surgical or anesthetic complications. Only phone calls for pain within 3 days were significantly different. The LB group had 3.2% of patients call compared to 5.6% in the nonliposomal bupivacaine group (aOR = 1.71 (95% CI: 1.04-2.87), p=0.036). We found no significant difference in any of the other secondary outcomes. CONCLUSIONS: The use of LB in an ISB demonstrated no significant difference compared to nonliposomal bupivacaine in numbers of complications, emergency room visits, and readmissions.

Pooled Dosing and Efficacy Analysis of the Sufentanil Sublingual Tablet 30 mcg Across Demographic Subgroups for the Management of Moderate-to-Severe Acute Pain.

PURPOSE: To aid nurses in dosing sufentanil sublingual tablet (SST) 30 mcg administered via a single-dose applicator, dosing requirements and efficacy of SST 30 mcg were analyzed across age, sex, race, and body mass index subgroups. DESIGN: Patient characteristics were pooled from three postoperative studies (two placebo-controlled and one open-label) and one open-label emergency department study. Drug dosing and efficacy data were pooled from the postoperative studies. METHODS: Efficacy was assessed through summed pain intensity difference to baseline during 12 hours across subgroups. FINDINGS: Mean (standard deviation) drug doses administered from 0 to 12 hours was 3.9 (2.0) for SST 30 mcg and was less frequent for older (≥65 years) versus younger patients. The summed pain intensity difference to baseline during 12 hours was superior with SST 30 mcg versus placebo across all subgroups. CONCLUSIONS: SST 30 mcg is a sublingual opioid analgesic with efficacy across demographic subgroups.

Ultrasound-guided subcostal transversus abdominis plane block with liposomal bupivacaine compared to bupivacaine infiltration for patients undergoing robotic-assisted and laparoscopic hysterectomy: a prospective randomized study.

PURPOSE: To determine if a transversus abdominis plane (TAP) block with liposomal bupivacaine reduces total postoperative opioid use in the first 72 hrs following laparoscopic or robotic hysterectomy compared to port-site infiltration with 0.25% bupivacaine. METHODS: Patients received either a true TAP block procedure with 266 mg liposomal bupivacaine and 50 mg of 0.25% bupivacaine and sham port infiltration or sham TAP block procedure with true port-site infiltration with 100-125 mg of 0.25% bupivacaine. All patients had a standardized, scheduled, non-opioid pain management plan. The primary outcome was total IV morphine equivalents used in the first 72 hrs following surgery. Secondary outcomes included assessment of postoperative pain over the study period and quality of recovery measures. RESULTS: Patients undergoing TAP blockade required fewer total opioid equivalents during the observation period than patients allocated to infiltration (median 21 versus 25 mg IV Morphine equivalents, P=0.03). Opioid use was highest in the first 24 hrs after surgery, with less difference between the groups during days 2 and 3 postoperatively. There were 5 in the TAP group and 0 in the infiltration group were opioid free at 72 hrs. Those in the TAP group had improved quality of recovery (QoR15) with no change in overall benefit of analgesia score. CONCLUSION: TAP blockade reduced the requirement for opioid pain medication in the first 72 hrs after surgery, had more patients opioid free at 72 hrs, and improved patients' quality of their recovery.

The addition of intrathecal morphine to a transversus abdominis plane block with liposome bupivacaine provides more effective analgesia than transversus abdominis plane block with liposome bupivacaine alone: a retrospective study.

OBJECTIVE: The purpose of this study was to determine if the standardization of using liposomal bupivacaine in transversus abdominis plane (LB TAP) blocks eliminated the benefit of intrathecal morphine (ITM) in patients after undergoing a cesarean section. METHODS: This was a retrospective review of 358 patients who underwent cesarean section over an 11-month period. Patients were divided into two groups: those who received only an LB TAP (67 patients) vs those who received an LB TAP and ITM (291 patients). All blocks were placed bilaterally under ultrasound guidance after closure of the surgical incision, and morphine was added to the spinal used for the case. RESULTS: The group that received ITM in addition to the LB TAP received less opioids in the first 24 hours (median 5 range 0-150 mg morphine equivalents [ME] vs 15 range 0-76 mg ME; P<0.001) and less opioids overall (35 mg range 0-450 mg ME vs 47.5 mg range 0-189 mg ME; P=0.041) when compared to the LB TAP block only group. There was no difference between the two groups in opioid use from 24 to 48 hours or 48 to 72 hours. CONCLUSION: Patients who received ITM in addition to an LB TAP block received less opioids in the first 24 hours and overall when compared to those who received an LB TAP alone. This suggests that ITM still plays a role in providing analgesia to patients who have also received an LB TAP block as a part of their multimodal pain regimen for cesarean sections.

Complications in Pediatric Regional Anesthesia: An Analysis of More than 100,000 Blocks from the Pediatric Regional Anesthesia Network.

WHAT WE ALREADY KNOW ABOUT THIS TOPIC: WHAT THIS ARTICLE TELLS US THAT IS NEW: BACKGROUND:: Complications in pediatric regional anesthesia are rare, so a large sample size is necessary to quantify risk. The Pediatric Regional Anesthesia Network contains data on more than 100,000 blocks administered at more than 20 children's hospitals. This study analyzed the risk of major complications associated with regional anesthesia in children. METHODS: This is a prospective, observational study of routine clinical practice. Data were collected on every regional block placed by an anesthesiologist at participating institutions and were uploaded to a secure database. The data were audited at multiple points for accuracy. RESULTS: There were no permanent neurologic deficits reported (95% CI, 0 to 0.4:10,000). The risk of transient neurologic deficit was 2.4:10,000 (95% CI, 1.6 to 3.6:10,000) and was not different between peripheral and neuraxial blocks. The risk of severe local anesthetic systemic toxicity was 0.76:10,000 (95% CI, 0.3 to 1.6:10,000); the majority of cases occurred in infants. There was one epidural abscess reported (0.76:10,000, 95% CI, 0 to 4.8:10,000). The incidence of cutaneous infections was 0.5% (53:10,000, 95% CI, 43 to 64:10,000). There were no hematomas associated with neuraxial catheters (95% CI, 0 to 3.5:10,000), but one epidural hematoma occurred with a paravertebral catheter. No additional risk was observed with placing blocks under general anesthesia. The most common adverse events were benign catheter-related failures (4%). CONCLUSIONS: The data from this study demonstrate a level of safety in pediatric regional anesthesia that is comparable to adult practice and confirms the safety of placing blocks under general anesthesia in children.

Thoracic paravertebral block versus thoracic epidural analgesia for post-operative pain control in open pancreatic surgery: A randomized controlled trial.

STUDY OBJECTIVE: The purpose of this study was to compare the efficacy of bilateral ultrasound guided thoracic paravertebral catheters to a thoracic epidural after open pancreatic surgery. DESIGN: This was a prospective non-blinded randomized controlled trial. SETTING: Academic hospital operating room, postoperative recovery area, and ward. PATIENTS: 53 patients aged 18 and above who had open pancreatic surgery. INTERVENTIONS: Patients received either bilateral thoracic paravertebral block at T8 with an infusion of 0.2% ropivacaine or thoracic epidural analgesia at T7/8 with an infusion of 0.125% bupivacaine with hydromorphone 6 µg/mL. MEASUREMENTS: Pain scores, opioid use, length of recovery room and hospital stay, adverse events, and incidence of nausea and vomiting. MAIN RESULTS: There was no difference in baseline demographics between the two groups. There were no significant differences in pain scores between the two groups in each of the first five days after surgery. There was no difference in length of stay nor nausea and vomiting. There was significantly less modality related adverse events in the paravertebral group compared to the epidural group (p = 0.02). CONCLUSIONS: The use of thoracic paravertebral catheters provided comparable analgesia and less modality related adverse events when compared to a thoracic epidural in patients undergoing open pancreaticoduodenectomy.

Laparoscopic transdiaphragmatic chest surgery: Early experience.

OBJECTIVE: We describe laparoscopic transdiaphragmatic (LTD) chest surgery without intercostal incisions and focus on technique and safety. The goal of LTD is to minimize postoperative pain. METHODS: We reviewed all patients undergoing LTD chest surgery (September 8, 2010-April 4, 2017). We place 4 abdominal ports with the patient in semilateral decubitus, make 2 diaphragmatic openings, and advance 2 ports into the chest. The intrathoracic operation is standard video-assisted thoracoscopic surgery (VATS), and diaphragmatic openings are closed at the end. We compared narcotic use (morphine equivalents) between patients undergoing LTD lung resection with historical controls undergoing conventional VATS. RESULTS: We performed 28 LTD chest procedures (wedge, 19; lobectomy, 3; segmentectomy, 3; other, 3; right sided, 20). Indications were lung nodule (14), lung cancer (5), interstitial lung disease (6), and other (3). Median operative times were 138 minutes (96-240 minutes) for wedge resection and 296 minutes (255-356 minutes, including transcervical mediastinal lymphadenectomy) for anatomic resections. Respiratory complications occurred in 3 patients and other complications in 5 (total 8; 28.6%). Computed tomography in 22 patients (79%) at median 13 months (3-47 months) after surgery showed no diaphragmatic hernia. LTD chest surgery patients used less narcotics than conventional VATS without paravertebral block 24 to 48 hours postoperatively (P = .039). CONCLUSIONS: Early experience suggests that LTD chest surgery is feasible and safe on short- to midterm follow-up. The specific role of LTD chest surgery will require definition of patient selection criteria, further experience to reduce operative time, long-term follow-up, and prospective comparison with conventional VATS.

An Open-Label Study of Sufentanil Sublingual Tablet 30 Mcg in Patients with Postoperative Pain.

Objective: To evaluate sufentanil sublingual tablet 30 mcg (SST 30 mcg) for postoperative pain in an older patient population with comorbidities. Design: Multicenter, open-label, single-arm study. Setting: Nine hospitals across the United States. Subjects: Adults aged ≥40 years who had undergone a surgical procedure. Methods: Patients with a postoperative pain intensity score ≥4 on an 11-point numeric rating scale (NRS) were allowed to enter the study and receive SST 30 mcg as requested for pain (minimum 60-minute redosing interval) over the 12-hour study period. Efficacy was assessed by patient reports of pain intensity on the NRS and a five-point pain relief scale. Safety was monitored throughout the study; plasma sufentanil concentrations were also measured. The primary efficacy endpoint was the time-weighted summed pain intensity difference (SPID) to baseline over 12 hours (SPID12). Results: Of the 140 patients enrolled, 69% were American Society of Anesthesiologists Physical Class II or III, 44% had a body mass index (BMI) ≥30 mg/kg2, and 29% had hepatic and/or renal impairment. Average age was 54.7 years (SD = 9.9 years), and average baseline pain intensity was 6.2 (SD = 1.9). The most common surgeries were abdominal (59%) and orthopedic (20%). The mean SPID12 was 36.0 (standard error of the mean = 2.2); mean scores were similar, regardless of age, sex, race, and BMI. From baseline, mean pain intensity decreased significantly starting 30 minutes postdose, and mean pain relief increased significantly starting 15 minutes postdose, remaining relatively stable through 12 hours (P < 0.001 at each time point). Four (3%) patients discontinued due to inadequate analgesia, and 45 (32%) patients had one or more adverse events that were considered possibly or probably related to the study drug. Mean plasma sufentanil concentrations were generally similar regardless of age, sex, BMI, or organ impairment status. Conclusions: SST 30 mcg was effective and well tolerated for the management of moderate-to-severe acute postoperative pain.

An evaluation of the analgesic effect of AnestaGel™ on mechanical allodynia in a rat model of postoperative incisional pain.

PURPOSE: Sustained release hydrogel with bupivacaine (AnestaGel™) is a novel formulation of extended release bupivacaine in a biohydrogel Matrix™. We sought to compare the analgesic effects via mechanical allodynia, the pharmacokinetic characteristics via serum blood levels, and the local tissue effects via pathology, following injection of either sustained release hydrogel with bupivacaine, liposome bupivacaine, or hydrogel only (negative control group). MATERIALS AND METHODS: Ninety rats (30 in each group) were randomized to receive a sciatic nerve block injection of either sustained release hydrogel with bupivacaine, liposome bupivacaine (Exparel®), or a biohydrogel matrix. The total force generated was obtained at varying time points. Pathologic analysis was undertaken on days 5 and 42 of the study. Six additional rats (two in each group) were randomized to receive a sciatic nerve block injection of either sustained release hydrogel with bupivacaine, liposome bupivacaine, or bupivacaine and pharmacokinetic data were obtained for up to 120 hours. RESULTS: The sustained release hydrogel with bupivacaine group had significantly better response to mechanical allodynia compared to the other two groups. The pathology showed no significant adverse events at 42 days in any group. Finally, bupivacaine was present longer in the serum of sustained release hydrogel with bupivacaine group than the other two groups. CONCLUSION: The sustained release hydrogel with bupivacaine achieved longer lasting analgesia with no significant findings on pathology at 42 days when compared to both positive and negative controls.

Multimodal Analgesia in Breast Surgical Procedures: Technical and Pharmacological Considerations for Liposomal Bupivacaine Use.

Enhanced recovery after surgery is a multidisciplinary perioperative clinical pathway that uses evidence-based interventions to improve the patient experience as well as increase satisfaction, reduce costs, mitigate the surgical stress response, accelerate functional recovery, and decrease perioperative complications. One of the most important elements of enhanced recovery pathways is multimodal pain management. Herein, aspects relating to multimodal analgesia following breast surgical procedures are discussed with the understanding that treatment decisions should be individualized and guided by sound clinical judgment. A review of liposomal bupivacaine, a prolonged-release formulation of bupivacaine, in the management of postoperative pain following breast surgical procedures is presented, and technical guidance regarding optimal administration of liposomal bupivacaine is provided.

Enhanced Recovery Program and Length of Stay After Laparotomy on a Gynecologic Oncology Service: A Randomized Controlled Trial.

OBJECTIVE: To estimate whether a rapid recovery program would reduce length of stay among patients undergoing laparotomy on a gynecologic oncology service. METHODS: We conducted a prospective, randomized, controlled trial comparing an enhanced recovery after surgery protocol with routine postoperative care among women undergoing laparotomy on the gynecologic oncology service. Protocol elements included: preoperative counseling, regional anesthesia, intraoperative fluid restriction, and early postoperative ambulation and feeding. A sample size of 50 per group (N=100) was planned to achieve 80% power to detect a two-day difference in our primary outcome, length of hospital stay; secondary outcomes included: total daily narcotics used, time to postoperative milestones, and complications. RESULTS: A total of 112 women were enrolled between 2013 and 2015. Nine patients did not undergo laparotomy and were excluded, leaving 52 and 51 patients in the control and intervention groups, respectively. There was no difference in length of stay between the two groups (median 3.0 in both groups; P=.36). Enhanced recovery after surgery patients used less narcotics on day 0 (10.0 compared with 5.5 morphine equivalents in the control and intervention arms, respectively, P=.09) and day 2 (10.0 compared with 7.5 morphine equivalents, respectively; P=.05); however, there was no statistically significant difference between groups in any of the secondary outcomes. Post hoc analysis based on actual anesthesia received also failed to demonstrate a difference in time to discharge. CONCLUSION: When compared with usual care, introducing a formal enhanced recovery after surgery protocol did not significantly reduce length of stay. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, https://clinicaltrials.gov, NCT01705288.

Paravertebral Catheter Use for Postoperative Pain Control in Patients After Lung Transplant Surgery: A Prospective Observational Study.

OBJECTIVE: Effective postoperative pain management has been shown to be a positive predictive factor for postoperative recovery following a thoracotomy. The primary objective of this study was to examine the efficacy and safety of continuous paravertebral blockade in managing acute postsurgical pain following unilateral and bilateral single-lung transplantation. DESIGN: The authors conducted a prospective observational trial of patients. SETTING: The study was conducted in an academic university hospital. PARTICIPANTS: Patients (≥18 years of age) who underwent either unilateral or bilateral single-lung transplantation and received a postoperative paravertebral catheter. INTERVENTIONS: Paravertebral catheters were placed via an ultrasound-guided technique on either postoperative day 1 or 2. After placement, a continuous infusion of 0.2% ropivacaine was run at 0.2 to 0.25 mL/kg/h with maximum dose of 7 mL/h per side in bilateral lung transplant patients, and 14 mL/h in unilateral lung transplant patients. MEASUREMENTS AND MAIN RESULTS: Patients were followed up to 120 hours after placement of catheters, and pain scores, opioid use, and adverse events were recorded. There were 35 patients who completed the study from October 2013 to December 2014 (21 bilateral transplants and 14 unilateral transplants). The mean time to paravertebral catheter placement was 1.14 days in the overall group, with median time to extubation occurring 543 minutes after placement (range, 23-2,985 minutes). Catheters remained in place for a mean of 7.18 days. The mean maximal pain scores for both groups was 5.94 (day 1), 6.26 (day 2), 6.20 (day 3), 5.12 (day 4), and 5.60 (day 5). There were no adverse events related to the paravertebral catheters in either group. CONCLUSIONS: Paravertebral catheters provide a feasible option for postoperative pain control following unilateral or bilateral single-lung transplant in adult patients. Future research should focus on randomized trials of thoracic epidurals compared to paravertebral catheters.

Ultrasound-Guided Paravertebral Catheter Versus Intercostal Blocks for Postoperative Pain Control in Video-Assisted Thoracoscopic Surgery: A Prospective Randomized Trial.

OBJECTIVE: The use of continuous paravertebral (PV) catheters for management of acute postsurgical pain after video-assisted thoracoscopic surgery (VATS) has not been investigated previously as a randomized controlled trial. The purpose of this study was to compare the efficacy of an ultrasound-guided continuous PV catheter catheter infusion for postoperative pain control with single-shot intercostal blocks (ICB). DESIGN: A prospective, randomized, controlled trial. SETTING: An academic university hospital. PARTICIPANTS: Patients (≥18 years of age) who underwent a VATS procedure. INTERVENTIONS: Patients were randomized into 2 groups. Group 1 received single-shot ICB. Group 2 received an ultrasound-guided PV catheter with a continuous infusion of 0.2% ropivacaine. MEASUREMENTS AND MAIN RESULTS: There were 25 patients in group 1 and 23 patients in group 2. The maximum pain score was significantly lower in the group that received the PV catheter compared with those who received ICB during 24 to 48 hours (3.65 v 6.44, p<0.001). Seventeen patients (74%) who received PV catheters reported satisfaction with a pain control regimen compared to the 11 (44%) who received ICB (p = 0.036). In addition, during 24 to 48 hours after surgery the mean opioid use decreased significantly in the PV catheter group (14.39 v 30.50 mg morphine equivalents, p = 0.046). CONCLUSIONS: Ultrasound-guided continuous PV catheter infusions provided prolonged pain control and superior patient satisfaction compared with single-shot ICB after video-assisted thoracoscopic surgery.