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Percutaneous Peripheral Nerve Stimulation (Neuromodulation) for Postoperative Analgesia (pPNS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02898103
Recruitment Status : Completed
First Posted : September 13, 2016
Last Update Posted : April 5, 2019
Sponsor:
Collaborators:
University California Academic Senate
Copenhagen University Hospital at Herlev
SPR Therapeutics
Information provided by (Responsible Party):
Brian M. Ilfeld, MD, MS, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Device: Ultrasound-guided percutaneous peripheral nerve stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Percutaneous Peripheral Nerve Stimulation (Neuromodulation) for Postoperative Analgesia
Actual Study Start Date : February 24, 2017
Actual Primary Completion Date : July 20, 2018
Actual Study Completion Date : September 20, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Electrical current
electrical current will be introduced to the insulated percutaneous lead(s) for 5 minutes
Device: Ultrasound-guided percutaneous peripheral nerve stimulation
Using ultrasound guidance, the small electrical lead is inserted adjacent to a target peripheral nerve through a percutaneously introduced 20-gauge needle. Following needle withdrawal, the percutaneous lead is attached to a miniature stimulator half the size of a business card that is simply adhered to the skin. When activated, the (active) stimulator generates a small electrical current which passes through the insulated leads to the uninsulated lead tip, which activates nerve fibers (placebo stimulators do not generate current).
Other Name: Ultrasound-guided percutaneous peripheral neuromodulation

Placebo Comparator: Placebo
NO electrical current will be introduced to the insulated percutaneous lead(s) for 5 minutes
Device: Ultrasound-guided percutaneous peripheral nerve stimulation
Using ultrasound guidance, the small electrical lead is inserted adjacent to a target peripheral nerve through a percutaneously introduced 20-gauge needle. Following needle withdrawal, the percutaneous lead is attached to a miniature stimulator half the size of a business card that is simply adhered to the skin. When activated, the (active) stimulator generates a small electrical current which passes through the insulated leads to the uninsulated lead tip, which activates nerve fibers (placebo stimulators do not generate current).
Other Name: Ultrasound-guided percutaneous peripheral neuromodulation




Primary Outcome Measures :
  1. Change from baseline of surgical site pain level (NRS) at rest [ Time Frame: The change from baseline and 5 minutes after the active (non-sham) electrical stimulator is first activated ]
    the difference between the baseline pain score and pain score 5 minutes after the active (non-sham) electrical stimulator is first activated


Secondary Outcome Measures :
  1. Change from baseline of surgical site pain level (NRS) at rest [ Time Frame: Baseline, 1-5 minutes after stimulator A and B are activated, then 5 and 30 minutes after stimulator C is activated ]
    Surgical site pain level (NRS) at rest [average and worst recorded for post-discharge time points]

  2. Change from baseline of surgical site pain level (NRS) with motion (dynamic) [ Time Frame: Baseline, 1-5 minutes after stimulator A and B are activated, then 5 and 30 minutes after stimulator C is activated ]
    Surgical site pain level (NRS) with motion (dynamic) [average and worst recorded for post-discharge time points]

  3. Lead-related pain (NRS) [ Time Frame: Baseline, 5 minutes after stimulator A and B are activated, and then 5 and 30 minutes after stimulator C is activated ]
    Pain in the area of the lead or down the target nerve measured on the NRS

  4. Change from baseline in muscle strength [ Time Frame: Baseline, 5 minutes after stimulator A and B are activated, then 5 and 30 minutes after stimulator C is activated, then daily for 14 days, and at Months 1 and 3 ]
    Muscle strength measured with a dynamometer for all time points within the recovery room; and, then subjective description following discharge

  5. Sensory deficits [both cold and light touch] [ Time Frame: Baseline, 5 minutes after stimulator A and B are activated, then 5 and 30 minutes after stimulator C is activated, then daily for 14 days, and at Months 1 and 3 ]
    Deficit to cold (alcohol swab) and light touch [fingertips] within the target nerve distribution for all time points within the recovery room; and, then subjective description following discharge

  6. Adequate analgesia? [ Time Frame: Baseline, 5 minutes after stimulator A and B are activated, then 5 and 30 minutes after stimulator C is activated, then daily for 14 days, and at Months 1 and 3 ]
    Subjects will respond with a "yes" or "no" to the question "do you consider your current level of pain to be acceptable?"

  7. Supplemental analgesics [ Time Frame: Baseline, 5 minutes after stimulator A and B are activated, then 5 and 30 minutes after stimulator C is activated, then daily for 14 days, and at Months 1 and 3 ]
    Opioids and other supplemental analgesics (including a perineural local anesthetic infusion)


Other Outcome Measures:
  1. Adverse events [ Time Frame: Lead insertion through 3 months following insertion ]
    All device-related adverse events will be recorded and reported



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:

  • 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

Exclusion Criteria:

  • 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

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): NCT02898103


Locations
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United States, California
UCSD Medical Center, Thornton
La Jolla, California, United States, 92037
Ucsd Ctri
La Jolla, California, United States, 92097
UCSD Medical Center, Hillcrest
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
University California Academic Senate
Copenhagen University Hospital at Herlev
SPR Therapeutics
Investigators
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Principal Investigator: Brian M Ilfeld, MD, MS University California San Diego
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Brian M. Ilfeld, MD, MS, Professor of Anesthesiology, In Residence, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02898103    
Other Study ID Numbers: Percutaneous PNS Postop pilot
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms