Percutaneous Peripheral Nerve Stimulation (Neuromodulation) for Postoperative Analgesia

Summary

The moderate-to-severe pain many patients experience following orthopedic surgery is often treated with opioids, which are associated with side effects such as nausea/vomiting, sedation, and respiratory depression (and a risk of abuse). Potent site-specific analgesia with fewer side effects may be provided with a "continuous peripheral nerve block," which involves the percutaneous insertion of a catheter adjacent to the peripheral nerve(s) supplying a surgical site. Local anesthetic is introduced via the catheter. However, there are major problems with continuous nerve blocks that have dramatically limited their use outside academic centers. Percutaneous peripheral nerve stimulation (PNS) or "nerve modulation" is an alternative method of pain control involving the insertion of an electrical lead through an introducing needle-obviating an open surgical incision for placement-followed by the introduction of electric current to produce analgesia. This modality has been used to treat chronic pain, but it has not been evaluated with a randomized, controlled study when applied to acute pain management (post-surgical analgesia). This temporary therapy has multiple theoretical benefits over existing analgesics, such as a lack of systemic side effects (e.g., nausea, respiratory depression), an absence of induced muscle weakness, and a reduced risk of adverse events (e.g. infection). The purpose of the proposed randomized, double-masked, placebo-controlled, crossover, feasibility study is to explore the possibility of treating postoperative pain with ultrasound-guided percutaneous PNS and, if so, to help power a subsequent definitive randomized, controlled trial.

Conditions

• Postoperative Pain

Interventions

DEVICE

Percutaneous peripheral nerve stimulation

Active electrical stimulation for 5 minutes in the recovery room

DEVICE

Sham stimulation

Sham (placebo) stimulation for 5 minutes in the recovery room

DEVICE

Percutaneous peripheral nerve stimulation

Active electrical stimulation for 2-4 weeks at home

Sponsors & Collaborators

• University California Academic Senate

  collaborator UNKNOWN

• Copenhagen University Hospital at Herlev

  collaborator OTHER

• 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

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-02-24

Primary Completion

2018-07-20

Completion

2018-09-20

FDA Device

Yes

Countries

• United States

Study Locations