Percutaneous Peripheral Nerve Stimulation (Neuromodulation) for Postoperative Pain: A Randomized, Sham-controlled Pilot Study

Brian M. Ilfeld; Anthony Plunkett; Alice M. Vijjeswarapu; Robert Hackworth; Sandeep Dhanjal; Alparslan Turan; Steven P. Cohen; James C. Eisenach; Scott Griffith; Steven Hanling; Daniel I. Sessler; Edward J. Mascha; Dongsheng Yang; Joseph W. Boggs; Amorn Wongsarnpigoon; Harold Gelfand

doi:10.1097/ALN.0000000000003776

Percutaneous Peripheral Nerve Stimulation (Neuromodulation) for Postoperative Pain: A Randomized, Sham-controlled Pilot Study

Brian M. Ilfeld^*, Anthony Plunkett, Alice M. Vijjeswarapu, Robert Hackworth, Sandeep Dhanjal, Alparslan Turan, Steven P. Cohen, James C. Eisenach, Scott Griffith, Steven Hanling, Daniel I. Sessler, Edward J. Mascha, Dongsheng Yang, Joseph W. Boggs, Amorn Wongsarnpigoon, Harold Gelfand

^*Corresponding author for this work

Anesthesiology

Research output: Contribution to journal › Article › peer-review

53 Scopus citations

Abstract

Background: Percutaneous 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. Methods: Preoperatively, 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. Results: During 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). Conclusions: Percutaneous peripheral nerve stimulation reduced pain scores and opioid requirements free of systemic side effects during at least the initial week after ambulatory orthopedic surgery.

Original language	English (US)
Pages (from-to)	95-110
Number of pages	16
Journal	Anesthesiology
Volume	135
Issue number	1
DOIs	https://doi.org/10.1097/ALN.0000000000003776
State	Published - Jul 1 2021

Funding

Supported by the Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense, through the Pain Management Collaboratory–Pragmatic Clinical Trials Demonstration Projects under awardsW 81XWH-18-2-0003, W81XWH-18-2-0007, W81XWH-18-2-0008, and W81XWH-18-2-0009.The research reported in this publication was made possible by grant U24 AT009769 from the National Center for Complementary and Integrative Health (Bethesda,Maryland) and the Office of Behavioral and Social Sciences Research (Bethesda, Maryland). Opinions, interpretations, conclusions, and recommendations are those of the authors and are not necessarily endorsed by the funding agencies.This article is a product of the National Institutes of Health–Department of Defense–Department of Veterans Affairs Pain Management Collaboratory.

ASJC Scopus subject areas

Anesthesiology and Pain Medicine

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10.1097/ALN.0000000000003776

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Ilfeld, B. M., Plunkett, A., Vijjeswarapu, A. M., Hackworth, R., Dhanjal, S., Turan, A., Cohen, S. P., Eisenach, J. C., Griffith, S., Hanling, S., Sessler, D. I., Mascha, E. J., Yang, D., Boggs, J. W., Wongsarnpigoon, A., & Gelfand, H. (2021). Percutaneous Peripheral Nerve Stimulation (Neuromodulation) for Postoperative Pain: A Randomized, Sham-controlled Pilot Study. Anesthesiology, 135(1), 95-110. https://doi.org/10.1097/ALN.0000000000003776

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title = "Percutaneous Peripheral Nerve Stimulation (Neuromodulation) for Postoperative Pain: A Randomized, Sham-controlled Pilot Study",

abstract = "Background: Percutaneous 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. Methods: Preoperatively, 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. Results: During 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). Conclusions: Percutaneous peripheral nerve stimulation reduced pain scores and opioid requirements free of systemic side effects during at least the initial week after ambulatory orthopedic surgery.",

author = "Ilfeld, {Brian M.} and Anthony Plunkett and Vijjeswarapu, {Alice M.} and Robert Hackworth and Sandeep Dhanjal and Alparslan Turan and Cohen, {Steven P.} and Eisenach, {James C.} and Scott Griffith and Steven Hanling and Sessler, {Daniel I.} and Mascha, {Edward J.} and Dongsheng Yang and Boggs, {Joseph W.} and Amorn Wongsarnpigoon and Harold Gelfand",

year = "2021",

month = jul,

day = "1",

doi = "10.1097/ALN.0000000000003776",

language = "English (US)",

volume = "135",

pages = "95--110",

journal = "Anesthesiology",

issn = "0003-3022",

publisher = "Lippincott Williams and Wilkins",

number = "1",

}

Ilfeld, BM, Plunkett, A, Vijjeswarapu, AM, Hackworth, R, Dhanjal, S, Turan, A, Cohen, SP, Eisenach, JC, Griffith, S, Hanling, S, Sessler, DI, Mascha, EJ, Yang, D, Boggs, JW, Wongsarnpigoon, A & Gelfand, H 2021, 'Percutaneous Peripheral Nerve Stimulation (Neuromodulation) for Postoperative Pain: A Randomized, Sham-controlled Pilot Study', Anesthesiology, vol. 135, no. 1, pp. 95-110. https://doi.org/10.1097/ALN.0000000000003776

TY - JOUR

T1 - Percutaneous Peripheral Nerve Stimulation (Neuromodulation) for Postoperative Pain

T2 - A Randomized, Sham-controlled Pilot Study

AU - Ilfeld, Brian M.

AU - Plunkett, Anthony

AU - Vijjeswarapu, Alice M.

AU - Hackworth, Robert

AU - Dhanjal, Sandeep

AU - Turan, Alparslan

AU - Cohen, Steven P.

AU - Eisenach, James C.

AU - Griffith, Scott

AU - Hanling, Steven

AU - Sessler, Daniel I.

AU - Mascha, Edward J.

AU - Yang, Dongsheng

AU - Boggs, Joseph W.

AU - Wongsarnpigoon, Amorn

AU - Gelfand, Harold

PY - 2021/7/1

Y1 - 2021/7/1

N2 - Background: Percutaneous 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. Methods: Preoperatively, 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. Results: During 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). Conclusions: Percutaneous peripheral nerve stimulation reduced pain scores and opioid requirements free of systemic side effects during at least the initial week after ambulatory orthopedic surgery.

AB - Background: Percutaneous 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. Methods: Preoperatively, 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. Results: During 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). Conclusions: Percutaneous peripheral nerve stimulation reduced pain scores and opioid requirements free of systemic side effects during at least the initial week after ambulatory orthopedic surgery.

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ER -

Percutaneous Peripheral Nerve Stimulation (Neuromodulation) for Postoperative Pain: A Randomized, Sham-controlled Pilot Study

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