CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 7 enrolled
Drug / intervention
Percutaneous peripheral nerve stimulation +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02898103
NCT02898103N/ACompleted

Percutaneous Peripheral Nerve Stimulation (Neuromodulation) for Postoperative Analgesia: A Feasibility/Proof-of-Concept Study

University of California, San Diego·interventional·Posted Sep 13, 2016·Updated Apr 8, 2021

In Brief

A clinical study evaluating Percutaneous peripheral nerve stimulation and Sham stimulation for Postoperative Pain. Completed, enrolled 7 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedSep 13, 2016
Enrollment StartFeb 24, 2017
Primary CompletionJul 20, 2018
Study CompletionSep 20, 2018
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 9.8 years ago

Interventions

Percutaneous peripheral nerve stimulationdevice

Active electrical stimulation for 5 minutes in the recovery room

Sham stimulationdevice

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

Percutaneous peripheral nerve stimulationdevice

Active electrical stimulation for 2-4 weeks at home