Randomized Placebo-Controlled Trial of 60-Day Percutaneous Peripheral Nerve Stimulation Treatment Indicates Relief of Persistent Postoperative Pain, and Improved Function After Knee Replacement.

OBJECTIVES: Total knee arthroplasty (TKA) is an effective surgery for end-stage knee osteoarthritis, but chronic postoperative pain and reduced function affect up to 20% of patients who undergo such surgery. There are limited treatment options, but percutaneous peripheral nerve stimulation (PNS) is a promising nonopioid treatment option for chronic, persistent postoperative pain. The objective of the present study was to evaluate the effect of a 60-day percutaneous PNS treatment in a multicenter, randomized, double-blind, placebo-controlled trial for treating persistent postoperative pain after TKA. MATERIALS AND METHODS: Patients with postoperative pain after knee replacement were screened for this postmarket, institutional review board-approved, prospectively registered (NCT04341948) trial. Subjects were randomized to receive either active PNS or placebo (sham) stimulation. Subjects and a designated evaluator were blinded to group assignments. Subjects in both groups underwent ultrasound-guided placement of percutaneous fine-wire coiled leads targeting the femoral and sciatic nerves on the leg with postoperative pain. Leads were indwelling for eight weeks, and the primary efficacy outcome compared the proportion of subjects in each group reporting ≥50% reduction in average pain relative to baseline during weeks five to eight. Functional outcomes (6-minute walk test; 6MWT and Western Ontario and McMaster Universities Osteoarthritis Index) and quality of life (Patient Global Impression of Change) also were evaluated at end of treatment (EOT). RESULTS: A greater proportion of subjects in the PNS groups (60%; 12/20) than in the placebo (sham) group (24%; 5/21) responded with ≥50% pain relief relative to baseline (p = 0.028) during the primary endpoint (weeks 5-8). Subjects in the PNS group also walked a significantly greater distance at EOT than did those in the placebo (sham) group (6MWT; +47% vs -9% change from baseline; p = 0.048, n = 18 vs n = 20 completed the test, respectively). Prospective follow-up to 12 months is ongoing. CONCLUSIONS: This study provides evidence that percutaneous PNS decreases persistent pain, which leads to improved functional outcomes after TKA at EOT.

Continuous peripheral nerve blocks for analgesia following painful ambulatory surgery: a review with focus on recent developments in infusion technology.

PURPOSE OF REVIEW: Continuous peripheral nerve blocks (cPNB) decrease pain scores and opioid consumption while improving patient satisfaction following ambulatory surgery. This review focuses on the history and evolution of ambulatory cPNBs, recent developments in infusion technology that may prolong the duration of analgesia, optimal choice of cPNB for various surgical procedures, and novel analgesic modalities that may prove to be alternatives or supplements to cPNBs. RECENT FINDINGS: The primary factor limiting the duration of an ambulatory cPNB is the size of the local anesthetic reservoir. Recent evidence suggests the use of automated boluses, as opposed to continuous infusions, may decrease the rate of consumption of local anesthetic and, thereby, prolong the duration of analgesia. Utilizing a long-acting local anesthetic (e.g. ropivacaine) for initial block placement and an infusion start-delay timer may further increase this duration. SUMMARY: Patients undergoing painful ambulatory surgery are likely to have less pain and require fewer opioid analgesics when receiving a cPNB for postoperative analgesia. Advances in electronic pumps used for cPNBs may increase the duration of these benefits.

Wearable, noninvasive, pulsed shortwave (radiofrequency) therapy for analgesia and opioid sparing following outpatient surgery: A proof-of-concept case series.

BACKGROUND: It is often difficult to concurrently provide adequate analgesia while minimizing opioid requirements following ambulatory surgery. Nonthermal, pulsed shortwave (radiofrequency) fields are a noninvasive treatment used as an adjunct analgesic and wound healing therapy. The devices may be placed by nursing staff in less than a minute, are relatively inexpensive and readily available, theoretically provide analgesia for nearly any anatomic location, and have no systemic side effects-patients cannot detect any sensations from the devices-or significant risks. Here we present a case series to demonstrate the use of pulsed, electromagnetic field devices for outpatient herniorrhaphy and breast surgery. CASE REPORT: Following moderately painful ambulatory umbilical (n = 3) and inguinal (n = 2) hernia repair as well as bilateral breast surgery (n = 2), patients had taped over their surgical incision(s) 1 or 2 noninvasive, wearable, disposable, pulsed shortwave therapy devices (RecoveryRx, BioElectronics Corporation, Frederick, Maryland) which functioned continuously for 30 days. Average resting pain scores measured on the 0-10 numeric rating scale were a median of 0 during the entire treatment period. Six patients avoided opioid use entirely, while the remaining individual required only 5 mg of oxycodone during the first postoperative day. CONCLUSIONS: These cases demonstrate that the ambulatory use of pulsed shortwave devices is feasible and may be an effective analgesic, possibly obviating opioid requirements following outpatient herniorrhaphy and breast surgery. Considering the lack of any side effects, adverse events, and misuse/dependence/diversion potential, further study with a randomized, controlled trial appears warranted.

Basal Infusion versus Automated Boluses and a Delayed Start Timer for "Continuous" Sciatic Nerve Blocks after Ambulatory Foot and Ankle Surgery: A Randomized Clinical Trial.

BACKGROUND: The common technique using a basal infusion for an ambulatory continuous peripheral nerve blocks frequently results in exhaustion of the local anesthetic reservoir before resolution of surgical pain. This study was designed to improve and prolong analgesia by delaying initiation using an integrated timer and delivering a lower hourly volume of local anesthetic as automated boluses. The hypothesis was that compared with a traditional continuous infusion, ropivacaine administered with automated boluses at a lower dose and 5-h delay would (1) provide at least noninferior analgesia (difference in average pain no greater than 1.7 points) while both techniques were functioning (average pain score day after surgery) and (2) result in a longer duration (dual primary outcomes). METHODS: Participants (n = 70) undergoing foot or ankle surgery with a popliteal-sciatic catheter received an injection of ropivacaine 0.5% with epinephrine (20 ml) and then were randomized to receive ropivacaine (0.2%) either as continuous infusion (6 ml/h) initiated before discharge or as automated boluses (8 ml every 2 h) initiated 5 h after discharge using a timer. Both groups could self-deliver supplemental boluses (4 ml, lockout 30 min); participants and outcome assessors were blinded to randomization. All randomized participants were included in the data analysis. RESULTS: The day after surgery, participants with automated boluses had a median [interquartile range] pain score of 0.0 [0.0 to 3.0] versus 3.0 [1.8 to 4.8] for the continuous infusion group, with an odds ratio of 3.1 (95% CI, 1.23 to 7.84; P = 0.033) adjusting for body mass index. Reservoir exhaustion in the automated boluses group occurred after a median [interquartile range] of 119 h [109 to 125] versus 74 h [57 to 80] for the continuous infusion group (difference of 47 h; 95% CI, 38 to 55; P < 0.001 adjusting for body mass index). CONCLUSIONS: For popliteal-sciatic catheters, replacing a continuous infusion initiated before discharge with automated boluses and a start-delay timer resulted in better analgesia and longer infusion duration.

Preoperative Ultrasound-guided Percutaneous Cryoneurolysis for the Treatment of Pain after Mastectomy: A Randomized, Participant- and Observer-masked, Sham-controlled Study.

BACKGROUND: Ultrasound-guided percutaneous cryoneurolysis is an analgesic technique in which a percutaneous probe is used to reversibly ablate a peripheral nerve(s) using exceptionally low temperature, and has yet to be evaluated with randomized, controlled trials. Pain after mastectomy can be difficult to treat, and the authors hypothesized that the severity of surgically related pain would be lower on postoperative day 2 with the addition of cryoanalgesia compared with patients receiving solely standard-of-care treatment. METHODS: Preoperatively, participants at one enrolling center received a single injection of ropivacaine, 0.5%, paravertebral nerve block at T3 or T4, and perineural catheter. Participants subsequently underwent an active or sham ultrasound-guided percutaneous cryoneurolysis procedure of the ipsilateral T2 to T5 intercostal nerves in a randomized, patient- and observer-masked fashion. Participants all received a continuous paravertebral block with ropivacaine, 0.2%, until the early morning of discharge (usually postoperative day 2). The primary endpoint was the average pain level measured using a 0 to 10 numeric rating scale the afternoon of postoperative day 2. Participants were followed for 1 yr. RESULTS: On postoperative day 2, participants who had received active cryoneurolysis (n = 31) had a median [interquartile range] pain score of 0 [0 to 1.4] versus 3.0 [2.0 to 5.0] in patients given sham (n = 29): difference -2.5 (97.5% CI, -3.5 to -1.5), P < 0.001. There was evidence of superior analgesia through month 12. During the first 3 weeks, cryoneurolysis lowered cumulative opioid use by 98%, with the active group using 1.5 [0 to 14] mg of oxycodone compared with 72 [20 to 120] mg in the sham group (P < 0.001). No oral analgesics were required by any patient between months 1 and 12. After 1 yr chronic pain had developed in 1 (3%) active compared with 5 (17%) sham participants (P < 0.001). CONCLUSIONS: Percutaneous cryoneurolysis markedly improved analgesia without systemic side effects or complications after mastectomy.

Regional Anesthesia Techniques for Pain Management for Laparoscopic Surgery: a Review of the Current Literature.

PURPOSE OF REVIEW: The field of regional anesthesia has evolved tremendously in the last 15 years. New anesthesia protocols for ambulatory surgery and enhanced recovery after surgery have been developed as well. The focus of these techniques and protocols has centered on patient satisfaction and pain control while minimizing the use of opioids. The field of ambulatory surgery and anesthesia continues to evolve, and regional anesthesia and its plane techniques are at the center of these changes. RECENT FINDINGS: Recent research has shown that regional techniques contribute to better pain control and patient experience and may decrease patient readmission rates. The safety of these techniques has been validated when performed by experienced practitioners. New techniques such as the erector spinae block (ESP) have been studied in the setting of laparoscopic surgery with promising results. Regional anesthesia techniques for patients presenting for laparoscopic surgery are safe and seem to provide benefits. Those are related to patient experience, pain control, and readmission rates. Different techniques can be applied to a specific type of intervention. Application of these techniques depend on the clinical picture and patient. Future research may help us clarify how these techniques may improve patient satisfaction and operating room efficiency. New regional blocks may also develop based on what we know today.

Monitored Anesthesia Care Versus General Anesthesia as the Primary Anesthetic for Ankle Amputations.

OBJECTIVES: The authors hypothesized that monitored anesthesia care (MAC)-either by local sedation or regional anesthesia (RA)-compared with general anesthesia (GA), would be associated with lower odds of significant 30-day postoperative complications and mortality in patients undergoing an ankle amputation. DESIGN: Retrospective cohort study. SETTING: Inpatient. PARTICIPANTS: The authors used data from patients who underwent ankle amputation from the American College of Surgeons National Surgical Quality Improvement Program registry. INTERVENTION: RA as primary anesthetic. MEASUREMENTS AND MAIN RESULTS: A multivariate logistic regression was used to evaluate the association of primary anesthesia type with the outcomes. The regression analysis included all covariates to test the association of the primary exposure variable (anesthesia type) with each outcome of interest. The odds ratio (OR), with associated 95% confidence interval (CI), was reported for each covariate. There were a total of 3,368 patients undergoing guillotine amputation through the tibia/fibula (n = 2,935) or ankle disarticulation (n = 433). Among these patients, 15.5% (n = 491) received MAC as their primary anesthetic. Among all patients, 11.4% (n = 363) experienced a significant postoperative complication. On multivariate logistic regression, MAC was found to decrease odds of postoperative complications (OR 0.57, 95% CI 0.40-0.82, p = 0.002), but not mortality (OR 1.26, 95% CI 0.87-1.84, p = 0.22). CONCLUSION: This study showed that MAC was associated with improved outcomes, as opposed to GA, as the primary anesthetic in ankle amputations.

Cryoneurolysis and Percutaneous Peripheral Nerve Stimulation to Treat Acute Pain.

Two regional analgesic modalities currently cleared by the U.S. Food and Drug Administration hold promise to provide postoperative analgesia free of many of the limitations of both opioids and local anesthetic-based techniques. Cryoneurolysis uses exceptionally low temperature to reversibly ablate a peripheral nerve, resulting in temporary analgesia. Where applicable, it offers a unique option given its extended duration of action measured in weeks to months after a single application. Percutaneous peripheral nerve stimulation involves inserting an insulated lead through a needle to lie adjacent to a peripheral nerve. Analgesia is produced by introducing electrical current with an external pulse generator. It is a unique regional analgesic in that it does not induce sensory, motor, or proprioception deficits and is cleared for up to 60 days of use. However, both modalities have limited validation when applied to acute pain, and randomized, controlled trials are required to define both benefits and risks.

Suture-method versus Through-the-needle Catheters for Continuous Popliteal-sciatic Nerve Blocks: A Randomized Clinical Trial.

BACKGROUND: The basic perineural catheter design has changed minimally since inception, with the catheter introduced through or over a straight needle. The U.S. Food and Drug Administration recently cleared a novel perineural catheter design comprising a catheter attached to the back of a suture-shaped needle that is inserted, advanced along the arc of its curvature pulling the catheter past the target nerve, and then exited through the skin in a second location. The authors hypothesized that analgesia would be noninferior using the new versus traditional catheter design in the first two days after painful foot/ankle surgery with a primary outcome of average pain measured with the Numeric Rating Scale. METHODS: Subjects undergoing painful foot or ankle surgery with a continuous supraparaneural popliteal-sciatic nerve block 5 cm proximal to the bifurcation were randomized to either a suture-type or through-the-needle catheter and subsequent 3-day 0.2% ropivacaine infusion (basal 6 ml/h, bolus 4 ml, lockout 30 min). Subjects received daily follow-up for the first four days after surgery, including assessment for evidence of malfunction or dislodgement of the catheters. RESULTS: During the first two postoperative days the mean ± SD average pain scores were lower in subjects with the suture-catheter (n = 35) compared with the through-the-needle (n = 35) group (2.7 ± 2.4 vs. 3.4 ± 2.4) and found to be statistically noninferior (95% CI, -1.9 to 0.6; P < 0.001). No suture-style catheter was completely dislodged (0%), whereas the tips of three (9%) traditional catheters were found outside of the skin before purposeful removal on postoperative day 3 (P = 0.239). CONCLUSIONS: Suture-type perineural catheters provided noninferior analgesia compared with traditional catheters for continuous popliteal-sciatic blocks after painful foot and ankle surgery. The new catheter design appears to be a viable alternative to traditional designs used for the past seven decades.

Continuous Popliteal-Sciatic Blocks for Postoperative Analgesia: Traditional Proximal Catheter Insertion Superficial to the Paraneural Sheath Versus a New Distal Insertion Site Deep to the Paraneural Sheath.

We tested the hypothesis that during a continuous popliteal-sciatic nerve block, postoperative analgesia is improved with the catheter insertion point "deep" to the paraneural sheath immediately distal to the bifurcation between the tibial and common peroneal branches, compared with the traditional approach "superficial" to the paraneural sheath proximal to the bifurcation. The needle tip location was determined to be accurately located with a fluid bolus visualized with ultrasound; however, catheters were subsequently inserted without a similar fluid injection and visualization protocol (visualized air injection was permitted and usually implemented, but not required per protocol). The average pain (0-10 scale) the morning after surgery for subjects with a catheter inserted at the proximal subparaneural location (n = 31) was a median (interquartile) of 1.5 (0.0-3.5) vs 1.5 (0.0-4.0) for subjects with a catheter inserted at the distal supraparaneural location (n = 32; P = .927). Secondary outcomes were similarly negative.

Ultrasound-Guided Posterior Antebrachial Cutaneous Nerve Block: Technical Description and Block Distribution in Healthy Volunteers.

The posterior antebrachial cutaneous nerve branches from the radial nerve proximal to the elbow and supplies sensation to the posterior aspect of the forearm. With a high-frequency linear transducer, the posterior antebrachial cutaneous nerve was identified in 8 healthy volunteers. Under aseptic conditions and with an ultrasound-guided in-plane technique, 1% lidocaine was injected circumferentially around the nerve. In each participant, the block was successful, and neither incidental blocks of other nerves nor any other complications were observed. These results demonstrate that the posterior antebrachial cutaneous nerve can be blocked to provide anesthesia or analgesia to the posterior forearm.

Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: Neuromodulation of the Femoral Nerve for Postoperative Analgesia Following Ambulatory Anterior Cruciate Ligament Reconstruction: A Proof of Concept Study.

OBJECTIVES: The purpose of this prospective proof of concept study was to investigate the feasibility of using percutaneous peripheral nerve stimulation of the femoral nerve to treat pain in the immediate postoperative period following ambulatory anterior cruciate ligament reconstruction with a patellar autograft. MATERIALS AND METHODS: Preoperatively, an electrical lead (SPRINT, SPR Therapeutics, Inc., Cleveland, OH, USA) was percutaneously implanted with ultrasound guidance anterior to the femoral nerve caudad to the inguinal crease. Within the recovery room, subjects received 5 min of either stimulation or sham in a randomized, double-masked fashion followed by a 5-min crossover period, and then continuous active stimulation until lead removal postoperative Day 14-28. Statistics were not applied to the data due to the small sample size of this feasibility study. RESULTS: During the initial 5-min treatment period, subjects randomized to stimulation (n = 5) experienced a slight downward trajectory (decrease of 7%) in their pain over the 5 min of treatment, while those receiving sham (n = 5) reported a slight upward trajectory (increase of 4%) until their subsequent 5-min stimulation crossover, during which time they also experienced a slight downward trajectory (decrease of 11% from baseline). A majority of subjects (80%) used a continuous adductor canal nerve block for rescue analgesia (in addition to stimulation) during postoperative Days 1-3, after which the median resting and dynamic pain scores remained equal or less than 1.5 on the numeric rating scale, respectively, and the median daily opioid consumption was less than 1.0 tablet. CONCLUSIONS: This proof of concept study demonstrates that percutaneous femoral nerve stimulation is feasible for ambulatory knee surgery; and suggests that this modality may be effective in providing analgesia and decreasing opioid requirements following anterior cruciate ligament reconstruction. clinicaltrials.gov: NCT02898103.

Proximal Versus Distal Continuous Adductor Canal Blocks: Does Varying Perineural Catheter Location Influence Analgesia? A Randomized, Subject-Masked, Controlled Clinical Trial.

BACKGROUND: A continuous adductor canal block provides analgesia after surgical procedures of the knee. Recent neuroanatomic descriptions of the thigh and knee led us to speculate that local anesthetic deposited in the distal thigh close to the adductor hiatus would provide superior analgesia compared to a more proximal catheter location. We therefore tested the hypothesis that during a continuous adductor canal nerve block, postoperative analgesia would be improved by placing the perineural catheter tip 2-3 cm cephalad to where the femoral artery descends posteriorly to the adductor hiatus (distal location) compared to a more proximal location at the midpoint between the anterior superior iliac spine and the superior border of the patella (proximal location). METHODS: Preoperatively, subjects undergoing total knee arthroplasty received an ultrasound-guided perineural catheter inserted either in the proximal or distal location within the adductor canal in a randomized, subject-masked fashion. Subjects received a single injection of lidocaine 2% via the catheter preoperatively, followed by an infusion of ropivacaine 0.2% (8 mL/h basal, 4 mL bolus, 30 minutes lockout) for the study duration. After joint closure, the surgeon infiltrated the entire joint using 30 mL of ropivacaine (0.5%), ketorolac (30 mg), epinephrine (5 µg/mL), and tranexamic acid (2 g). The primary end point was the median level of pain as measured on a numeric rating scale (NRS) during the time period of 8:00 AM to 12:00 PM the day after surgery. RESULTS: For the primary end point, the NRS of subjects with a catheter inserted at the proximal location (n = 24) was a median (10th, 25th-75th, 90th quartiles) of 0.5 (0.0, 0.0-3.2, 5.0) vs 3.0 (0.0, 2.0-5.4, 7.8) for subjects with a catheter inserted in the distal location (n = 26; P = .011). Median and maximum NRSs were lower in the proximal group at all other time points, but these differences did not reach statistical significance. There were no clinically relevant or statistically significant differences between the treatment groups for any other secondary end point, including opioid consumption and ambulation distance. CONCLUSIONS: For continuous adductor canal blocks accompanied by intraoperative periarticular local anesthetic infiltration, analgesia the day after knee arthroplasty is improved with a catheter inserted at the level of the midpoint between the anterior superior iliac spine and the superior border of the patella compared with a more distal insertion closer to the adductor hiatus.