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

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ClinicalTrials.gov Identifier: NCT03481725
Recruitment Status : Enrolling by invitation
First Posted : March 29, 2018
Last Update Posted : September 18, 2018
Sponsor:
Collaborators:
Uniformed Services University of the Health Sciences
Walter Reed National Military Medical Center
Wake Forest Medical Center
Augusta University
The Cleveland Clinic
Brooke Army Medical Center
United States Naval Medical Center, San Diego
Palo Alto VA
Womack Army Medical Center
SPR Therapeutics
Information provided by (Responsible Party):
Brian M. Ilfeld, MD, MS, University of California, San Diego

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.


Condition or disease Intervention/treatment Phase
Rotator Cuff Repair Anterior Cruciate Ligament Reconstruction With a Patella Autograph Ankle Arthrodesis or Arthroplasty Hallux Valgus Correction Device: ACTIVE peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator (SPR Therapeutics, Cleveland, Ohio) Device: SHAM peripheral nerve stimulation with a percutaneously inserted lead and wearable SHAM stimulator (SPR Therapeutics, Cleveland, Ohio) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: A Non-Pharmacologic Alternative for the Treatment of Postoperative Pain
Actual Study Start Date : July 14, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
Drug Information available for: Coal Tar

Arm Intervention/treatment
Experimental: Peripheral Nerve Stimulation
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)
ACTIVE peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator (SPR Therapeutics, Cleveland, Ohio) that generates electric current for 14 days

Sham Comparator: Sham
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)
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




Primary Outcome Measures :
  1. Opioid consumption during first postoperative week [ Time Frame: Postoperative days 0-7 ]
    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

  2. Average pain during first postoperative week [ Time Frame: Postoperative days 0-7 ]
    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


Secondary Outcome Measures :
  1. Opioid consumption individual time points [ Time Frame: Postoperative days 0, 1, 2, 3, 4, 7, 11, and 15; as well as Months 1, 4, and 12 ]
    Cumulative opioid dose of previous 24 hours

  2. Average pain at individual time points [ Time Frame: Postoperative days 0, 1, 2, 3, 4, 7, 11, and 15; as well as Months 1, 4, and 12 ]
    Measured using the numeric rating scale for the previous 24 hours. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain

  3. Worst/maximum pain at individual time points [ Time Frame: Postoperative days 0, 1, 2, 3, 4, 7, 11, and 15; as well as Months 1, 4, and 12 ]
    Measured using the numeric rating scale for the previous 24 hours. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain

  4. Brief Pain Inventory, short form [ Time Frame: Postoperative days 0, 3, 7, and 15; as well as Months 1, 4, and 12 ]
    The Brief Pain Inventory (short form) is an instrument specifically designed to assess pain and its impact on physical and emotional functioning. The Brief Pain Inventory is comprised of three domains: (1) pain, with four questions involving "worst", "average", "least", and "current" pain levels using a 0-10 numeric rating scale; (2) percentage of relief provided by pain treatments with one question [reported score is the percentage divided by 10 and then subtracted from 10: 0 = complete relief, 10 = no relief]; and, (3) interference with 7 questions involving physical and emotional functioning using a 0-10 Likert scale [0 = no interference; 10 = complete interference]: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.

  5. Defense and Veterans pain rating scale [ Time Frame: Postoperative days 0, 3, 7, and 15; as well as Months 1, 4, and 12 ]
    Instrument designed to assess pain level specifically for active duty military and Veteran patient populations. It is a Likert scale from 0 (no pain) to 10 (worst imaginable pain).

  6. World Health Organization Quality of Life-BREF Instrument [ Time Frame: Postoperative day 0 and Months 1, 4, and 12 ]
    The World Health Organization Quality of Life (WHOQoL-BREF) Instrument is specifically designed to evaluate clinically important, patient-relevant changes in health-related quality of life. The WHOQoL-BREF focuses on those aspects of life most important to patients & is composed of 24 questions assessing 4 dimensions: (1) physical health, (2) psychological health, (3) social relationships, and (4) environment. Two additional items involve individuals' overall perception of their quality of life and health. Each of the 26 questions is rated on a 0-5 scale, and then summed to produce both a total score as well as domain-specific scores for more in depth analysis. Domain scores are scaled in a positive direction. The mean score of items within each domain is used to calculate the domain score. Mean scores are then converted to range between 0-100 to enable comparisons to be made between domains comprised of unequal numbers of questions.

  7. Post-Traumatic Stress Disorder checklist [ Time Frame: Postoperative day 0 (baseline) ]
    A 20-item self-report measure reflecting symptoms of post-traumatic stress disorder validated in military, Veteran, and civilian populations.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years of age or older
  2. 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
  3. with a planned single-injection peripheral nerve block for postoperative analgesia

Exclusion Criteria:

  1. chronic analgesic use including opioids (daily use within the 2 weeks prior to surgery and duration of use > 4 weeks)
  2. neuro-muscular deficit of the target nerve(s)
  3. 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
  4. implanted spinal cord stimulator, cardiac pacemaker/defibrillator, deep brain stimulator, or other implantable neurostimulator whose stimulus current pathway may overlap
  5. history of bleeding disorder
  6. antiplatelet or anticoagulation therapies other than aspirin due to the risk of bleeding with a 20-gauge insertion needle
  7. allergy to skin-contact materials (occlusive dressings, bandages, tape etc.)
  8. incarceration
  9. pregnancy
  10. chronic pain of greater than 3 months of any severity in an anatomic location other than the surgical extremity
  11. anxiety disorder
  12. history of substance abuse
  13. inability to contact the investigators during the treatment period, and vice versa (e.g., lack of telephone access).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03481725


Locations
United States, California
Veterans Affairs Palo Alto Health Care System
Palo Alto, California, United States, 94304
University California San Diego
San Diego, California, United States, 92103
Naval Medical Center San Diego
San Diego, California, United States, 92134
United States, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
United States, North Carolina
Womack Army medical Center
Fort Bragg, North Carolina, United States, 28310
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
Sponsors and Collaborators
University of California, San Diego
Uniformed Services University of the Health Sciences
Walter Reed National Military Medical Center
Wake Forest Medical Center
Augusta University
The Cleveland Clinic
Brooke Army Medical Center
United States Naval Medical Center, San Diego
Palo Alto VA
Womack Army Medical Center
SPR Therapeutics
Investigators
Principal Investigator: Brian M Ilfeld, MD, MS University California San Diego

Responsible Party: Brian M. Ilfeld, MD, MS, Professor of Anesthesiology, In Residence, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03481725     History of Changes
Other Study ID Numbers: Postop STIMULATION (DoD)
NH170005 ( Other Grant/Funding Number: Department of Defense )
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Hallux Valgus
Foot Deformities
Musculoskeletal Diseases
Coal Tar
Keratolytic Agents
Dermatologic Agents