Percutaneous Peripheral Nerve Stimulation (Neuromodulation) for Postoperative Analgesia

Completed · Not applicable · Has a placebo group

Conditions studied: Postoperative Pain

In brief

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.

Key facts

Study ID

NCT02898103

Run by

University of California, San Diego

People needed

7

Starts

2017-02-24

Expected to finish

2018-09-20

Last updated by the study team

2021-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Undergoing orthopedic surgical procedure that frequently results in moderate-to-severe postoperative pain
• At least 18 years of age
• Able to understand and willing to take part in study and adhere to all study requirements

You may not qualify if…

• Postoperative analgesic plan includes a single-injection peripheral nerve block in the surgical extremity
• Chronic opioid use (daily use within the 2 weeks prior to surgery and duration of use > 4 weeks)
• Known neuro-muscular deficit of the target nerve(s)
• Anticipated MRI within the following 2 weeks
• Compromised immune system based on medical history (e.g., immunosuppressive therapies such as chemotherapy, radiation, sepsis, infection), or other conditions that places the subject at increased risk in the opinion of the investigator
• Implanted spinal cord stimulator, cardiac pacemaker/defibrillator, deep brain stimulator, or other implantable neurostimulator whose stimulus current pathway may overlap
• History of bleeding disorder
• Antiplatelet or anticoagulation therapies other than aspirin
• Allergy to all local anesthetic agents such as lidocaine or previous reaction to anesthesia
• Allergy to skin-contact materials (occlusive dressings, bandages, tape etc.)
• Any other condition that may interfere with ability to participate in a clinical trial (e.g., anatomy that may interfere with lead placement) as determined by the Investigators
• Incarceration
• Pregnancy

Where it is running

• UCSD Medical Center, Thornton — La Jolla, California, United States
• Ucsd Ctri — La Jolla, California, United States
• UCSD Medical Center, Hillcrest — San Diego, California, United States

Full record on ClinicalTrials.gov

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