Percutaneous Peripheral Nerve Stimulation (Neuromodulation) for Postoperative Analgesia

NCT02898103 | Completed Results FDA Device

• 1 other identifier: Percutaneous PNS Postop pilot
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline of Surgical Site Pain Level (NRS) at Rest [Percentage of Baseline Pain]

  Pain is evaluated on a Numeric Rating Scale: 0-10 scale with 0=no pain and 10=worst imaginable pain. The outcome measure is calculated as such: the pain score 5 and then 10 minutes after the stimulator is first activated on the Numeric Rating Scale divided by the baseline pain score measured on the same scale. Of note, although this is a crossover design, the order of treatment does influence the effects of each treatment, so the 7 total subjects cannot be grouped together for the active portion and then again for the sham portion--they must remain separate, distinct groups even though this is a crossover design.

  5 and 10 minutes after the stimulator is first activated

Other Outcomes (6)

• Percentage of Baseline Muscle Strength

  Two minutes following stimulation initiation following lead insertion

• Worst Pain at Rest

  Daily for Days 1-14 following surgery, then at 30 and 90 days

• Average Pain at Rest

  Daily for days 1-14 following surgery, then at 30 and 90 days

Study Arms (2)

Active Current then Sham then Active Current

EXPERIMENTAL

Electrical current will be introduced to the insulated percutaneous lead(s) for 5 minutes; then sham/placebo for 5 minutes; and then active electrical current for the following 2-4 weeks

Device: Percutaneous peripheral nerve stimulation; Device: Sham stimulation

Sham then Active Current

ACTIVE COMPARATOR

Sham/placebo will be introduced to the insulated percutaneous lead(s) for 5 minutes; then active electrical current for the following 2-4 weeks

Device: Percutaneous peripheral nerve stimulation; Device: Sham stimulation

Interventions

Percutaneous peripheral nerve stimulation DEVICE

Active electrical stimulation for 5 minutes in the recovery room

Also known as: Percutaneous peripheral neuromodulation, Ultrasound-guided percutaneous peripheral nerve stimulation

Active Current then Sham then Active Current; Sham then Active Current

Sham stimulation DEVICE

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

Active Current then Sham then Active Current; Sham then Active Current

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of California, San Diego: lead
• University California Academic Senate: collaborator
• Copenhagen University Hospital at Herlev: collaborator
• SPR Therapeutics, Inc.: collaborator

Study Sites (3)

UCSD Medical Center, Thornton

La Jolla, California, 92037, United States

Location

Ucsd Ctri

La Jolla, California, 92097, United States

Location

UCSD Medical Center, Hillcrest

San Diego, California, 92103, United States

Location

Related Publications (3)

• Ilfeld BM, Gabriel RA, Said ET, Monahan AM, Sztain JF, Abramson WB, Khatibi B, Finneran JJ 4th, Jaeger PT, Schwartz AK, Ahmed SS. Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: Neuromodulation of the Sciatic Nerve for Postoperative Analgesia Following Ambulatory Foot Surgery, a Proof-of-Concept Study. Reg Anesth Pain Med. 2018 Aug;43(6):580-589. doi: 10.1097/AAP.0000000000000819.

  PMID: 29905630 RESULT

• Ilfeld BM, Finneran JJ 4th, Gabriel RA, Said ET, Nguyen PL, Abramson WB, Khatibi B, Sztain JF, Swisher MW, Jaeger P, Covey DC, Meunier MJ, Hentzen ER, Robertson CM. Ultrasound-guided percutaneous peripheral nerve stimulation: neuromodulation of the suprascapular nerve and brachial plexus for postoperative analgesia following ambulatory rotator cuff repair. A proof-of-concept study. Reg Anesth Pain Med. 2019 Mar;44(3):310-318. doi: 10.1136/rapm-2018-100121. Epub 2019 Feb 15.

  PMID: 30770421 DERIVED

• Ilfeld BM, Said ET, Finneran JJ 4th, Sztain JF, Abramson WB, Gabriel RA, Khatibi B, Swisher MW, Jaeger P, Covey DC, Robertson CM. Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: Neuromodulation of the Femoral Nerve for Postoperative Analgesia Following Ambulatory Anterior Cruciate Ligament Reconstruction: A Proof of Concept Study. Neuromodulation. 2019 Jul;22(5):621-629. doi: 10.1111/ner.12851. Epub 2018 Aug 30.

  PMID: 30160335 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Brian Ilfeld, MD, MS
• Organization: University California San Diego

bilfeld@ucsd.edu

858-822-0776

Study Officials

• Brian M Ilfeld, MD, MS

  University California San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Treatment group assignments were unmasked after the leads were removed 2 weeks after surgery.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, In Residence

Study Record Dates

• First Submitted: September 2, 2016
• First Posted: September 13, 2016
• Study Start: February 24, 2017
• Primary Completion: July 20, 2018
• Study Completion: September 20, 2018
• Last Updated: April 8, 2021
• Results First Posted: March 15, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)