TY - JOUR
T1 - Percutaneous Neuromodulation of the Brachial Plexus and Sciatic Nerve for the Treatment of Acute Pain Following Surgery
T2 - Secondary Outcomes From a Multicenter, Randomized, Controlled Pilot Study
AU - PAINfRE Investigators
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 - Han, Yanyan
AU - Boggs, Joseph W.
AU - Wongsarnpigoon, Amorn
AU - Gelfand, Harold
N1 - Funding Information:
Source(s) of financial support: The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick, MD 21702‐5014 is the awarding and administering acquisition office. This work was 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 Awards No. W81XWH‐18‐2‐0003, W81XWH‐18‐2‐0007, W81XWH‐18‐2‐0008, and W81XWH‐18‐2‐0009. Research reported in this publication was made possible by Grant Number U24 AT009769 from the National Center for Complementary and Integrative Health (NCCIH), and the Office of Behavioral and Social Sciences Research (OBSSR). Opinions, interpretations, conclusions, and recommendations are those of the authors and are not necessarily endorsed by the funding agencies. This manuscript is a product of the NIH‐DoD‐VA Pain Management Collaboratory. For more information about the Collaboratory, visit https://painmanagementcollaboratory.org .
Funding Information:
Source(s) of financial support: The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick, MD 21702-5014 is the awarding and administering acquisition office. This work was 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 Awards No. W81XWH-18-2-0003, W81XWH-18-2-0007, W81XWH-18-2-0008, and W81XWH-18-2-0009. Research reported in this publication was made possible by Grant Number U24 AT009769 from the National Center for Complementary and Integrative Health (NCCIH), and the Office of Behavioral and Social Sciences Research (OBSSR). Opinions, interpretations, conclusions, and recommendations are those of the authors and are not necessarily endorsed by the funding agencies. This manuscript is a product of the NIH-DoD-VA Pain Management Collaboratory. For more information about the Collaboratory, visit https://painmanagementcollaboratory.org.
Funding Information:
Harold Gelfand is participating in Henry Jackson Foundation (Bethesda, MD, USA) funded research through a grant from Pacira Pharmaceuticals (Parsippany, NJ, USA). Brian M. Ilfeld's institution has received funding for other research from Infutronix (Natick, MA, USA), Epimed International (Farmers Branch, TX, USA), and SPR Therapeutics (Cleveland, OH, USA). Daniel I. Sessler serves as a consultant for Pacira Pharmaceuticals (Parsippany, NJ, USA). The author's institution receives funding from Pacira Pharmaceuticals (Parsippany, NJ, USA) and Heron Therapeutics (San Diego, CA, USA). Alparslan Turan's institution receives funding from Pacira Pharmaceuticals (Parsippany, NJ, USA) and Heron Therapeutics (San Diego, CA, USA). Joseph W. Boggs and Amorn Wongsarnpigoon are employees of SPR Therapeutics, the manufacturer of the electrical leads and pulse generators under investigation in this study. Both authors own stock options in this company. Of note, this was an investigator‐initiated project fully funded by the U.S. Department of Defense, and the first author retained complete control of the grant proposal, study protocol, data collection, analysis, and interpretation, and the resulting manuscript. Drs. Boggs and Wongsarnpigoon were provided the initial protocol on which to comment, with some suggested revisions incorporated into the protocol while others were not. The remaining authors report no conflicts. Conflict of Interest:
Publisher Copyright:
© 2022 The Authors
PY - 2023/4
Y1 - 2023/4
N2 - Objectives: We recently reported that percutaneous peripheral nerve stimulation (PNS or “neuromodulation”) decreased pain and opioid consumption within the first two weeks following ambulatory surgery. However, the anatomic lead locations were combined for the analysis, and benefits for each location remain unknown. We therefore now report the effects of percutaneous PNS for brachial plexus and sciatic nerve leads separately. Materials and Methods: Before surgery, leads were implanted percutaneously to target the brachial plexus (N = 21) for rotator cuff repair or sciatic nerve (N = 40) for foot/ankle surgery, followed by a single injection of local anesthetic. Postoperatively, subjects were randomized in a double masked fashion to 14 days of electrical stimulation (N = 30) or sham/placebo (N = 31) using an external pulse generator. The primary outcome of interest was opioid consumption and pain scores evaluated jointly. Thus, stimulation was deemed effective if superior on either outcome and at least noninferior on the other. Results: For brachial plexus leads, during the first seven postoperative days pain measured with the numeric rating scale in participants given active stimulation was a median [interquartile range] of 0.8 [0.5, 1.6] versus 3.2 [2.7, 3.5] in patients given sham (p < 0.001). For this same group, opioid consumption in participants given active stimulation was 10 mg [5, 20] versus 71 mg [35, 125] in patients given sham (p = 0.043). For sciatic nerve leads, pain scores for the active treatment group were 0.7 [0, 1.4] versus 2.8 [1.6, 4.6] in patients given sham (p < 0.001). During this same period, participants given active stimulation consumed 5 mg [0, 30] of opioids versus 40 mg [20, 105] in patients given sham (p = 0.004). Treatment effects did not differ statistically between the two locations. Conclusions: Ambulatory percutaneous PNS of both the brachial plexus and sciatic nerve is an effective treatment for acute pain free of systemic side effects following painful orthopedic surgery.
AB - Objectives: We recently reported that percutaneous peripheral nerve stimulation (PNS or “neuromodulation”) decreased pain and opioid consumption within the first two weeks following ambulatory surgery. However, the anatomic lead locations were combined for the analysis, and benefits for each location remain unknown. We therefore now report the effects of percutaneous PNS for brachial plexus and sciatic nerve leads separately. Materials and Methods: Before surgery, leads were implanted percutaneously to target the brachial plexus (N = 21) for rotator cuff repair or sciatic nerve (N = 40) for foot/ankle surgery, followed by a single injection of local anesthetic. Postoperatively, subjects were randomized in a double masked fashion to 14 days of electrical stimulation (N = 30) or sham/placebo (N = 31) using an external pulse generator. The primary outcome of interest was opioid consumption and pain scores evaluated jointly. Thus, stimulation was deemed effective if superior on either outcome and at least noninferior on the other. Results: For brachial plexus leads, during the first seven postoperative days pain measured with the numeric rating scale in participants given active stimulation was a median [interquartile range] of 0.8 [0.5, 1.6] versus 3.2 [2.7, 3.5] in patients given sham (p < 0.001). For this same group, opioid consumption in participants given active stimulation was 10 mg [5, 20] versus 71 mg [35, 125] in patients given sham (p = 0.043). For sciatic nerve leads, pain scores for the active treatment group were 0.7 [0, 1.4] versus 2.8 [1.6, 4.6] in patients given sham (p < 0.001). During this same period, participants given active stimulation consumed 5 mg [0, 30] of opioids versus 40 mg [20, 105] in patients given sham (p = 0.004). Treatment effects did not differ statistically between the two locations. Conclusions: Ambulatory percutaneous PNS of both the brachial plexus and sciatic nerve is an effective treatment for acute pain free of systemic side effects following painful orthopedic surgery.
KW - Ambulatory surgery
KW - percutaneous peripheral nerve stimulation
KW - postoperative analgesia
KW - regional anesthesia
KW - ultrasound-guided regional anesthesia
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U2 - 10.1111/ner.13492
DO - 10.1111/ner.13492
M3 - Article
C2 - 34343394
AN - SCOPUS:85133787331
SN - 1094-7159
VL - 26
SP - 638
EP - 649
JO - Neuromodulation
JF - Neuromodulation
IS - 3
ER -