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

NCT03481725 | Completed Results DMC FDA Device

• 2 other identifiers: Pilot STIMULATION (DoD)NH170005
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 6

Brief 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

Outcome Measures

Primary Outcomes (2)

• Opioid Consumption During First Postoperative Week

  Cumulative opioid dose from days 0-7, collected on days 0, 1, 2, 3, 4, and 7 for the previous 24 hours at each time point measured in morphine equivalents

  Postoperative days 0-7

• Average Pain During First Postoperative Week

  Mean value of the "average" pain scores measured using the numeric rating scale, collected on days 0, 1, 2, 3, 4, and 7 for the previous 24 hours at each time point. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain

  Postoperative days 0-7

Secondary Outcomes (7)

• Opioid Consumption Individual Time Points

  Postoperative days 1, 2, 3, 4, 7, 11, and 15; as well as Months 1 and 4

• Brief Pain Inventory, Short Form (Interference Domain)

  Postoperative days 3, and 7; as well as Months 1 and 4

• Average Pain at Individual Time Points

  Postoperative days 1, 2, 3, 4, 7, 11, and 15; as well as Months 1 and 4

• Worst Pain at Individual Time Points

  Postoperative days 1, 2, 3, 4, 7, 11, and 15; as well as Months 1 and 4

• Least Pain at Individual Time Points

  Postoperative days 3 and 7; as well as Months 1 and 4

Study Arms (2)

Peripheral Nerve Stimulation

EXPERIMENTAL

ACTIVE percutaneous peripheral nerve stimulation with an ultrasound-guided percutaneous lead (SPR Therapeutics, Cleveland, Ohio) and wearable stimulator (SPR Therapeutics, Cleveland, Ohio) that generates electrical current

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

Sham

SHAM COMPARATOR

SHAM percutaneous peripheral nerve stimulation with an ultrasound-guided percutaneous lead (SPR Therapeutics, Cleveland, Ohio) and wearable stimulator (SPR Therapeutics, Cleveland, Ohio) that does NOT generate electrical current

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

Interventions

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

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

Peripheral Nerve Stimulation

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

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

Sham

Eligibility Criteria

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

You may qualify if:

• years of age or older
• undergoing one of the following surgical procedures: rotator cuff repair, anterior cruciate ligament repair with a patellar autograph, ankle arthrodesis or arthroplasty, hallux valgus correction
• with a planned single-injection peripheral nerve block for postoperative analgesia

You may not qualify if:

• chronic analgesic use including opioids (daily use within the 2 weeks prior to surgery and duration of use \> 4 weeks)
• neuro-muscular deficit of the target nerve(s)
• 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
• 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 due to the risk of bleeding with a 20-gauge insertion needle
• allergy to skin-contact materials (occlusive dressings, bandages, tape etc.)
• incarceration
• pregnancy
• chronic pain of greater than 3 months of any severity in an anatomic location other than the surgical extremity
• anxiety disorder
• history of substance abuse
• inability to contact the investigators during the treatment period, and vice versa (e.g., lack of telephone access).

Sponsors & Collaborators

• University of California, San Diego: lead
• Uniformed Services University of the Health Sciences: collaborator
• Walter Reed National Military Medical Center: collaborator
• Wake Forest University Health Sciences: collaborator
• Augusta University: collaborator
• The Cleveland Clinic: collaborator
• Brooke Army Medical Center: collaborator
• United States Naval Medical Center, San Diego: collaborator
• VA Palo Alto Health Care System: collaborator
• Womack Army Medical Center: collaborator
• SPR Therapeutics, Inc.: collaborator

Study Sites (6)

University California San Diego

San Diego, California, 92103, United States

Location

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Womack Army medical Center

Fort Bragg, North Carolina, 28310, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Related Publications (1)

• Ilfeld BM, Gelfand H, Dhanjal S, Hackworth R, Plunkett A, Turan A, Vijjeswarapu AM, Cohen SP, Eisenach JC, Griffith S, Hanling S, Mascha EJ, Sessler DI. Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: A Pragmatic Effectiveness Trial of a Nonpharmacologic Alternative for the Treatment of Postoperative Pain. Pain Med. 2020 Dec 12;21(Suppl 2):S53-S61. doi: 10.1093/pm/pnaa332.

  PMID: 33313729 DERIVED

Results Point of Contact

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

m1medeiros@health.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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, In Residence

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: March 29, 2018
• Study Start: July 14, 2018
• Primary Completion: September 11, 2020
• Study Completion: January 7, 2021
• Last Updated: March 18, 2021
• Results First Posted: March 18, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)