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Improving Postamputation Functioning by Decreasing Phantom Pain With Perioperative Continuous Peripheral Nerve Blocks: A Department of Defense Funded Multicenter Study

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ClinicalTrials.gov Identifier: NCT03461120
Recruitment Status : Enrolling by invitation
First Posted : March 9, 2018
Last Update Posted : April 26, 2019
Sponsor:
Collaborators:
United States Department of Defense
United States Naval Medical Center, San Diego
The Cleveland Clinic
University of Texas MD Anderson
Walter Reed National Military Medical Center
Johns Hopkins University
Wake Forest Medical Center
Information provided by (Responsible Party):
Brian M. Ilfeld, MD, MS, University of California, San Diego

Brief Summary:
When a limb is amputated, pain perceived in the part of the body that no longer exists often develops, called "phantom limb" pain. The exact reason that phantom limb pain occurs is unclear, but when a nerve is cut-as happens with an amputation-changes occur in the brain and spinal cord that are associated with persistent pain. The negative feedback-loop between the injured limb and the brain can be stopped by putting local anesthetic-called a "nerve block"-on the injured nerve, effectively keeping any "bad signals" from reaching the brain. A "continuous peripheral nerve block" (CPNB) is a technique providing pain relief that involves inserting a tiny tube-smaller than a piece of spaghetti-through the skin and next to the target nerve. Local anesthetic is then introduced through the tiny tube, which bathes the nerve in the numbing medicine. This provides a multiple-day block that provides opioid-free pain control with no systemic side effects, and may prevent the destructive feedback loop that results in phantom limb pain following an amputation. We propose a multicenter, randomized, triple-masked (investigators, subjects, statisticians), placebo-controlled, parallel arm, human-subjects clinical trial to determine if a prolonged, high-concentration (dense), perioperative CPNB improves post-amputation physical and emotional functioning while decreasing opioid consumption, primarily by preventing chronic phantom limb pain.

Condition or disease Intervention/treatment Phase
Lower Extremity Surgical Amputation Post-amputation Phantom Limb Pain Drug: Experimental continuous peripheral nerve blocks Drug: Control continuous peripheral nerve blocks Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 218 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The only individuals aware of treatment assignment will be the Investigational Drug Service pharmacists who prepare the treatment infusate
Primary Purpose: Prevention
Official Title: Improving Postamputation Functioning by Decreasing Phantom Limb Pain and Opioid Use With Perioperative Continuous Peripheral Nerve Blocks: A Multicenter RCT
Actual Study Start Date : March 23, 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2022

Arm Intervention/treatment
Experimental: Treatment
Bupivacaine 0.3% infusion for 7 days via femoral and sciatic perineural catheters
Drug: Experimental continuous peripheral nerve blocks
Bupivacaine 0.3% infusions for 7 days via femoral and sciatic perineural catheters
Other Name: Experimental perineural local anesthetic infusion

Control
Bupivacaine 0.1% infusion for 1 day followed by normal saline for a total of 7 days via femoral and sciatic perineural catheters
Drug: Control continuous peripheral nerve blocks
Bupivacaine 0.1% infusions for 1 day followed by normal saline for a total of 7 days via femoral and sciatic perineural catheters
Other Name: Control perineural local anesthetic infusion




Primary Outcome Measures :
  1. Locomotor Capabilities Index-5 [ Time Frame: Postoperative Month 9 ]
    comprised of 14 items, all scored on a 5-point ordinal scale. Each question inquires about the ability and level of independence when performing a specific activity. There are two subscales comprised of 7 questions each evaluating basic and advanced abilities, but the primary end point of the current study will involve the total score that includes both activity levels.


Secondary Outcome Measures :
  1. Locomotor Capabilities Index-5 [ Time Frame: Baseline; Months 6 and 12 ]
    comprised of 14 items, all scored on a 5-point ordinal scale. Each question inquires about the ability and level of independence when performing a specific activity. There are two subscales comprised of 7 questions each evaluating basic and advanced abilities.

  2. World Health Organization Disability Assessment Schedule 2.0 [ Time Frame: Baseline, Months 1, 3, 6, 9, and 12 ]
    The instrument was developed by the World Health Organization to focus on those aspects of life most important to patients,99 and is composed of 36 questions assessing functioning in 6 domains: (1) understanding and communication, (2) mobility, (3) self-care, (4) interactions with others, (5) life activities, and (6) participation in community/society. Each of the 36 questions is rated on a 0-4 scale (0: no difficulty; 4: extreme difficulty or cannot do), and then summed to produce both a total score as well as domain-specific scores for more in depth analysis.

  3. Beck Depression Inventory [ Time Frame: Baseline and Month 12 ]
    This is a 21-item instrument with each of the factors rated on a 0-3 scale, and then summed to produce the total score of 0-63

  4. Phantom limb pain [ Time Frame: Baseline, postoperative days 1, 2 and 8; Months 1, 3, 6, 9, and 12 ]
    Current/present, worst, least, and average phantom limb pain will be assessed using a Numeric Rating Scale (NRS) included in the Brief Pain Inventory (short form). The NRS is a highly-sensitive measure of pain intensity with numbers ranging from 0 to 10, zero equivalent to no pain and 10 equivalent to the worst imaginable pain.

  5. Residual limb pain [ Time Frame: Baseline, postoperative days 1, 2 and 8; Months 1, 3, 6, 9, and 12 ]
    Current/present, worst, least, and average residual limb pain will be assessed using a Numeric Rating Scale (NRS) included in the Brief Pain Inventory (short form). The NRS is a highly-sensitive measure of pain intensity with numbers ranging from 0 to 10, zero equivalent to no pain and 10 equivalent to the worst imaginable pain.

  6. Opioid consumption [ Time Frame: Baseline, postoperative days 1, 2 and 8; Months 1, 3, 6, 9, and 12 ]
    All opioids consumed (reported as oral morphine equivalents)

  7. Non-painful phantom limb sensations frequency [ Time Frame: Baseline, postoperative days 1, 2 and 8; Months 1, 3, 6, 9, and 12 ]
    non-painful sensations referred to the lost body part (frequency)

  8. Non-painful phantom limb sensations duration [ Time Frame: Baseline, postoperative days 1, 2 and 8; Months 1, 3, 6, 9, and 12 ]
    non-painful sensations referred to the lost body part (duration)

  9. Phantom limb pain frequency [ Time Frame: Baseline, postoperative days 1, 2 and 8; Months 1, 3, 6, 9, and 12 ]
    painful sensations referred to the lost body part (frequency)

  10. Phantom limb pain average duration [ Time Frame: Baseline, postoperative days 1, 2 and 8; Months 1, 3, 6, 9, and 12 ]
    painful sensations referred to the lost body part (average duration)

  11. Residual limb pain frequency [ Time Frame: Baseline, postoperative days 1, 2 and 8; Months 1, 3, 6, 9, and 12 ]
    painful sensations localized to the portion of limb still physically present (frequency)

  12. Residual limb pain duration [ Time Frame: Baseline, postoperative days 1, 2 and 8; Months 1, 3, 6, 9, and 12 ]
    painful sensations localized to the portion of limb still physically present (average duration)

  13. Masking assessment [ Time Frame: Postoperative day 8 ]
    Subject's belief of which treatment received reported as: definitely active, probably active, do not know, probably saline, or definitely saline



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:

  • scheduled for a unilateral lower limb amputation distal to the femoral head and including at least one metatarsal bone
  • continuous peripheral nerve blocks are planned for perioperative analgesia
  • willing to have their perineural infusion extended for a total of 7 days
  • willing to undergo ambulatory perineural infusion following hospital discharge

Exclusion Criteria:

  • Known hepatic or renal insufficiency
  • allergy to any study medication
  • pregnancy
  • incarceration
  • inability to communicate with the investigators
  • comorbidity precluding either perineural catheter insertion or subsequent ambulatory perineural infusion (e.g., current infection at the catheter insertion site, immune-compromised status of any etiology)
  • weight < 45 kg
  • inability to contact the investigators during the perineural infusion, and vice versa (e.g., lack of telephone access)
  • investigator opinion that the potential subject is not a good candidate for this particular study

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): NCT03461120


Locations
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United States, California
University California San Diego
San Diego, California, United States, 92103
Naval Medical Center San Diego
San Diego, California, United States, 92134
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
University of California, San Diego
United States Department of Defense
United States Naval Medical Center, San Diego
The Cleveland Clinic
University of Texas MD Anderson
Walter Reed National Military Medical Center
Johns Hopkins University
Wake Forest Medical Center
Investigators
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Principal Investigator: Brian M Ilfeld, MD, MS University California San Diego

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Responsible Party: Brian M. Ilfeld, MD, MS, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03461120     History of Changes
Other Study ID Numbers: Phantom pain PREVENTION (DoD)
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Phantom Limb
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Pain
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents