Dataset Information

Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: A Pragmatic Effectiveness Trial of a Nonpharmacologic Alternative for the Treatment of Postoperative Pain.

ABSTRACT:

Background

Percutaneous peripheral nerve stimulation (PNS) is an analgesic modality involving the insertion of a lead through an introducer needle followed by the delivery of electric current after needle withdrawal. This modality has been used extensively to treat chronic pain, but only small series have been published involving postoperative pain. The ultimate objective of this study is to determine the postoperative effects of percutaneous PNS following moderately to severely painful ambulatory surgery within a real-world clinical practice setting. The primary hypothesis is that surgical pain and opioid consumption during the initial 7 days after surgery will be reduced by percutaneous PNS compared with usual and customary analgesia (dual primary outcome measures).

Design

A multicenter pragmatic effectiveness trial. We are randomizing participants having painful orthopedic surgical procedures of the upper and lower extremity to receive 14 days of either 1) electrical stimulation or 2) sham in a double-masked fashion. End points are being assessed at various time points over 12 postoperative months.

Summary

The postoperative experience will be much improved if percutaneous PNS provides potent analgesia while concurrently decreasing opioid requirements following painful surgery. Because this modality can be administered for up to 60 days at home, it may provide postoperative analgesia that outlasts surgical pain yet has relatively few risks and, unlike opioids, has no systemic side effects or potential for abuse, addiction, and overdose. Percutaneous PNS has the potential to revolutionize postoperative analgesia as it has been practiced for the past century. This study will inform key stakeholders regarding an evidence-based nonpharmacologic approach to the management of postoperative pain.

SUBMITTER: Ilfeld BM

PROVIDER: S-EPMC7824994 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Publications

Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: A Pragmatic Effectiveness Trial of a Nonpharmacologic Alternative for the Treatment of Postoperative Pain.

Ilfeld Brian M BM Gelfand Harold H Dhanjal Sandeep S Hackworth Robert R Plunkett Anthony A Turan Alparslan A Vijjeswarapu Alice M AM Cohen Steven P SP Eisenach James C JC Griffith Scott S Hanling Steven S Mascha Edward J EJ Sessler Daniel I DI

Pain medicine (Malden, Mass.) 20201201 Suppl 2

<h4>Background</h4>Percutaneous peripheral nerve stimulation (PNS) is an analgesic modality involving the insertion of a lead through an introducer needle followed by the delivery of electric current after needle withdrawal. This modality has been used extensively to treat chronic pain, but only small series have been published involving postoperative pain. The ultimate objective of this study is to determine the postoperative effects of percutaneous PNS following moderately to severely painful ...[more]

PMID: 33313729

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Project description:BACKGROUND AND OBJECTIVES:Percutaneous peripheral nerve stimulation (PNS) is an analgesic modality involving the insertion of a lead through an introducing needle followed by the delivery of electric current. This modality has been reported to treat chronic pain as well as postoperative pain the day following knee surgery. However, it remains unknown if this analgesic technique may be used in ambulatory subjects following foot procedures beginning within the recovery room immediately following surgery, and with only short series of patients reported to date, the only available data are derived from strictly observational studies. The purposes of this proof-of-concept study were to demonstrate the feasibility of using percutaneous sciatic nerve PNS to treat postoperative pain following ambulatory foot surgery in the immediate postoperative period and provide the first available data from a randomized controlled study design to provide evidence of analgesic effect. METHODS:Preoperatively, an electrical lead (SPRINT; SPR Therapeutics, Inc, Cleveland, Ohio) was percutaneously inserted posterior to the sciatic nerve between the subgluteal region and bifurcation with ultrasound guidance. Following hallux valgus osteotomy, subjects received 5 minutes of either stimulation or sham in a randomized, double-masked fashion followed by a 5-minute crossover period and then continuous stimulation until lead removal on postoperative days 14 to 28. RESULTS:During the initial 5-minute treatment period, subjects randomized to stimulation (n = 4) experienced a downward trajectory in their pain over the 5 minutes of treatment, whereas those receiving sham (n = 3) reported no such change until their subsequent 5-minute stimulation crossover. During the subsequent 30 minutes of stimulation, pain scores decreased to 52% of baseline (n = 7). Three subjects (43%) used a continuous popliteal nerve block for rescue analgesia during postoperative days 0 to 3. Overall, resting and dynamic pain scores averaged less than 1 on the numeric rating scale, and opioid use averaged less than 1 tablet daily with active stimulation. One lead dislodged, 2 fractured during use, and 1 fractured during intentional withdrawal. CONCLUSIONS:This proof-of-concept study demonstrates that percutaneous sciatic nerve PNS is feasible for ambulatory foot surgery and suggests that this modality provides analgesia and decreases opioid requirements following hallux valgus procedures. However, lead dislodgement and fracture are concerns. CLINICAL TRIAL REGISTRATION:This study was registered at Clinicaltrials.gov, identifier NCT02898103.

Project description: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.

Project description:BackgroundPercutaneous peripheral nerve stimulation is an analgesic technique involving the percutaneous implantation of a lead followed by the delivery of electric current using an external pulse generator. Percutaneous peripheral nerve stimulation has been used extensively for chronic pain, but only uncontrolled series have been published for acute postoperative pain. The current multicenter study was undertaken to (1) determine the feasibility and optimize the protocol for a subsequent clinical trial and (2) estimate the treatment effect of percutaneous peripheral nerve stimulation on postoperative pain and opioid consumption.MethodsPreoperatively, an electrical lead was percutaneously implanted to target the sciatic nerve for major foot/ankle surgery (e.g., hallux valgus correction), the femoral nerve for anterior cruciate ligament reconstruction, or the brachial plexus for rotator cuff repair, followed by a single injection of long-acting local anesthetic along the same nerve/plexus. Postoperatively, participants were randomized to 14 days of either electrical stimulation (n = 32) or sham stimulation (n = 34) using an external pulse generator in a double-masked fashion. The dual primary treatment effect outcome measures were (1) cumulative opioid consumption (in oral morphine equivalents) and (2) mean values of the "average" daily pain scores measured on the 0 to 10 Numeric Rating Scale within the first 7 postoperative days.ResultsDuring the first 7 postoperative days, opioid consumption in participants given active stimulation was a median (interquartile range) of 5 mg (0 to 30) versus 48 mg (25 to 90) in patients given sham treatment (ratio of geometric means, 0.20 [97.5% CI, 0.07 to 0.57]; P < 0.001). During this same period, the average pain intensity in patients given active stimulation was a mean ± SD of 1.1 ± 1.1 versus 3.1 ± 1.7 in those given sham (difference, -1.8 [97.5% CI, -2.6 to -0.9]; P < 0.001).ConclusionsPercutaneous peripheral nerve stimulation reduced pain scores and opioid requirements free of systemic side effects during at least the initial week after ambulatory orthopedic surgery.Editor’s perspective

Project description:BackgroundTo investigate puncture skills and complications prevention in ultrasound-guided percutaneous needle biopsy for peripheral lung lesions.MethodsNinety-two peripheral lung lesions in 92 patients, detected via computed tomography (CT) and also visible on ultrasound, were retrospectively analyzed. All patients underwent percutaneous peripheral lung lesion needle biopsy under traditional ultrasound or contrast enhanced ultrasound (CEUS) guidance paying attention to avoiding necrotic areas and large blood vessels. All the specimens were examined histopathologically. Preprocedure all 92 lesions were performed by traditional ultrasonography to evaluate the size, the echogenecity, liquefaction areas and blood flow on color Doppler imaging, some of which were performed by CEUS for evaluating non-enhanced necrosis areas, contrast agent arrival time (AT) and characteristics of blood perfusion.ResultsThe histopathologic results of all 92 lesions were as follows: 67 malignant tumors (including 28 adenocarcinomas, 19 squamous cell carcinomas, 6 bronchoalveolar carcinomas, 5 small cell carcinomas, 5 metastatic cancers, 3 poorly differentiated cancers and 1 malignant mesothelioma), 20 benign lesions (including 9 pneumonia, 6 inflammatory pseudotumors and 5 tuberculomas), 5 undetermined lesions. Of 52 lesions by CEUS guidance, 7 lesions showed enhancement in the pulmonary arterial-phase (including 6 pneumonia and 1 malignant tumors), 45 lesions showed enhancement in the bronchial artery phase (including 37 malignant tumors, 3 inflammatory pseudotumors, 4 tuberculomas and 1 undetermined lesion). According to needle insertion angle along linear path, a total of 92 lesions were divided into two groups, 49 lesions at an angle of 70°-80° needle insertion and 43 lesions at an angle of 80°-90° needle insertion. In the study, linear and non-linear two puncture paths were used, we first tried to puncture along linear path in all lesions, if an attempt to insert into the lesions failed due to be blocked by the ribs and then changed to puncture along non-linear path instead. The success rate of biopsy procedure along linear puncture was significantly higher at an angle of 80°-90°group (93.0% vs. 20.4%, P<0.01), and the adoption rate of non-linear path biopsy for solving the puncture needle blocked by the ribs was significantly higher at angle of 70°-80°group (79.6% vs. 7.0%, P<0.01). Of 52 lesions by CEUS guidance, 27 (51.9%) showed non enhanced necrosis areas on CEUS, only 5 showed liquefaction necrosis areas on gray-scale ultrasound. Of 40 lesions by traditional ultrasound guidance, 4 showed necrosis areas on gray-scale ultrasound. There were no significant differences in lesion size, the average number of biopsy attempts and complication rates between CEUS guidance group and traditional ultrasound guidance group (P>0.05), the pathological confirmation rate in CEUS guidance group was higher than that in traditional ultrasound guidance group, but without significant difference (98.1% vs. 90.0%, P>0.05). Of all 92 cases, 3 cases (3.3%) had mild pneumothorax and 4 cases (4.3%) had hemoptysis.ConclusionsIn ultrasound-guided needle biopsy for peripheral lung lesions, using a combination of linear and non-linear puncture techniques and keeping away from necrotic areas and large blood vessels, may help to increase the success rate and reduce the incidence of complications further.

Dataset Information

Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: A Pragmatic Effectiveness Trial of a Nonpharmacologic Alternative for the Treatment of Postoperative Pain.

Background

Design

Summary

Publications

Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: A Pragmatic Effectiveness Trial of a Nonpharmacologic Alternative for the Treatment of Postoperative Pain.

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