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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | S53-S61 |
| Journal | Pain Medicine (United States) |
| Volume | 21 |
| DOIs | |
| State | Published - 2020 |
Funding
Conflicts of interest: James C. Eisenach, MD, provides consulting to Adynxx (San Francisco, CA). Harold Gelfand, MD, is participating in research funded by the Henry Jackson Foundation (Bethesda, MD) through a grant from Pacira Pharmaceuticals (Parsippany, NJ). The institution of Brian Ilfeld, MD, MS, has received funding from SPR Therapeutics (Cleveland, OH) for other research studies. The institution has also received funding for other research from Heron Pharmaceuticals (San Diego, CA), Infutronix (Natick, MA), Epimed International (Farmers Branch, TX), Myoscience (Fremont, CA), and Ferrosan Medical (Szczecin, Poland). Daniel I. Sessler, MD, is a consultant for Pacira Pharmaceuticals (Parsippany, NJ). The author’s institution receives funding from Pacira Pharmaceuticals and Heron Therapeutics (San Diego, CA). The institution of Alparslan Turan, MD, receives funding from Pacira Pharmaceuticals (Parsippany, NJ). The remaining authors report no conflicts of interest. The US Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick, MD 21702-5014, is the awarding and administering acquisition office. This study 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. The research reported in this article was supported by the National Center for Complementary and Integrative Health of the National Institutes of Health under Award No. U24AT009769. The 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-Veterans Affairs Pain Management Collaboratory. For more information about the Collaboratory, visit https://painmanagementcollaboratory.org. The authors appreciate the invaluable assistance of Baharin Abdullah (Clinical Translational Research Center, University of California, San Diego, La Jolla, CA). Supplement sponsorship: This article appears as part of the supplement entitled “NIH-DOD-VA Pain Management Collaboratory (PMC)”. This supplement 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). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NCCIH, OBSSR, and the National Institutes of Health. Funding sources: The US Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick, MD 21702-5014, is the awarding and administering acquisition office. This study 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. The research reported in this article was supported by the National Center for Complementary and Integrative Health of the National Institutes of Health under Award No. U24AT009769. The 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–Veterans Affairs Pain Management Collaboratory. For more information about the Collaboratory, visit https://painmanagement-collaboratory.org.
Keywords
- Neuromodulation
- Percutaneous peripheral nerve stimulation
- Postoperative analgesia
- Postoperative pain
ASJC Scopus subject areas
- General Medicine