Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: A Department of Defense Funded Multicenter Pilot Study

Summary

Postoperative pain is usually treated with opioids that have undesirable and sometimes dangerous side effects (e.g., vomiting and respiratory depression)-and yet over 80% of patients still experience inadequate pain relief. A novel, non-pharmacologic analgesic technique-percutaneous peripheral nerve stimulation (PNS)- holds extraordinary potential to greatly reduce or obviate opioid requirements and concurrently improve analgesia following painful surgery. This technique involves inserting an insulated electric lead adjacent to a target nerve through a needle prior to surgery using ultrasound guidance. Following surgery, a tiny electric current is delivered to the nerve resulting in potent pain control without any cognitive or adverse systemic side effects whatsoever. The electrical pulse generator (stimulator) is so small it is simply affixed to the patient's skin. The leads are already cleared by the US Food and Drug Administration to treat acute (postoperative) pain for up to 60 days; and, since percutaneous PNS may be provided on an outpatient basis, the technique holds the promise of providing potent analgesia outlasting the pain of surgery-in other words, the possibility of a painless, opioid-free recovery following surgery.

The current project is a multicenter, randomized, double-masked, placebo-controlled, parallel-arm clinical pilot study to (1) determine the feasibility and optimize the protocol of a planned definitive clinical trial; and (2) estimate the treatment effect of percutaneous PNS on pain and opioid consumption following moderate-to-severely painful ambulatory surgery compared with usual and customary opioid-based analgesia. This will allow determination of the required sample size for a subsequent definitive multicenter clinical trial. Combined, the pilot study and definitive trial have a strong potential to dramatically reduce or obviate postoperative opioid requirements and their resultant negative effects on both individuals and society; while concurrently improving analgesia, increasing the ability to function in daily life, decreasing the risk of transition from acute to chronic pain, and improving quality of life.

Conditions

• Rotator Cuff Repair
• Anterior Cruciate Ligament Reconstruction
• Ankle Arthrodesis or Arthroplasty
• Hallux Valgus Correction

Interventions

DEVICE

ACTIVE peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator (SPR Therapeutics, Cleveland, Ohio)

ACTIVE peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator (SPR Therapeutics, Cleveland, Ohio) that generates electric current for 14 days

DEVICE

SHAM peripheral nerve stimulation with a percutaneously inserted lead and wearable SHAM stimulator (SPR Therapeutics, Cleveland, Ohio)

SHAM peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator (SPR Therapeutics, Cleveland, Ohio) that does not generate electric current for 14 days

Sponsors & Collaborators

• Uniformed Services University of the Health Sciences

  collaborator FED

• Walter Reed National Military Medical Center

  collaborator FED

• Wake Forest University Health Sciences

  collaborator OTHER

• Augusta University

  collaborator OTHER

• The Cleveland Clinic

  collaborator OTHER

• Brooke Army Medical Center

  collaborator FED

• United States Naval Medical Center, San Diego

  collaborator FED

• VA Palo Alto Health Care System

  collaborator FED

• Womack Army Medical Center

  collaborator FED

• SPR Therapeutics, Inc.

  collaborator INDUSTRY

• University of California, San Diego

  lead OTHER

Principal Investigators

• Brian M Ilfeld, MD, MS · University California San Diego

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-07-14

Primary Completion

2020-09-11

Completion

2021-01-07

FDA Device

Yes

Countries

• United States

Study Locations