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.

Trial registration: ClinicalTrials.gov NCT03481725.

Keywords: Neuromodulation; Percutaneous Peripheral Nerve Stimulation; Postoperative Analgesia; Postoperative Pain.

Published by Oxford University Press on behalf of the American Academy of Pain Medicine. This work is written by a US Government employee and is in the public domain in the US.

Figures

Figure 1.

A percutaneous peripheral nerve stimulation system approved by the US Food and Drug Administration to treat acute pain (OnePass, SPR Therapeutics, Cleveland, OH). The insulated lead (MicroLead, SPR Therapeutics) is 0.2 mm in diameter wrapped into a helical coil 0.6 mm in diameter (top panel), which is percutaneously inserted using a preloaded introducer (middle panel). The rechargeable battery snaps into the pulse generator (SPRINT PNS System, SPR Therapeutics) and is controlled with a handheld remote control (bottom panels). Used with permission from Brian M. Ilfeld, MD, MS.

Figure 2.

The Pragmatic-Explanatory Continuum Indicator Summary 2 (PRECIS-2) wheel. Adapted by permission from BMJ Publishing Group Limited. [The PRECIS-2 tool: designing trials that are fit for purpose, Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. BMJ 2015;350:h2147].