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 : November 19, 2020
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Condition or disease | Intervention/treatment | Phase |
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Lower Extremity Surgical Amputation Post-amputation Phantom Limb Pain | Drug: Experimental continuous peripheral nerve blocks Drug: Control continuous peripheral nerve blocks | Phase 4 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 203 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 : | December 2022 |
Estimated Study Completion Date : | December 2023 |
Arm | Intervention/treatment |
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Experimental: Treatment
Bupivacaine 0.3% [or ropivacaine 0.5%] infusion for 7 days via femoral and sciatic perineural catheters
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Drug: Experimental continuous peripheral nerve blocks
Bupivacaine 0.3% [or ropivacaine 0.5%] infusions for 7 days via femoral and sciatic perineural catheters
Other Name: Experimental perineural local anesthetic infusion |
Control
Bupivacaine 0.1% [or ropivacaine 0.2%] infusion for 1 day followed by normal saline for a total of 7 days via femoral and sciatic perineural catheters
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Drug: Control continuous peripheral nerve blocks
Bupivacaine 0.1% [or ropivacaine 0.2%] 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 |
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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, Massachusetts | |
Mass. General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Brigham and Women's Hospital | |
Boston, Massachusetts, United States, 02115 | |
Boston VA | |
Boston, Massachusetts, United States, 02130 | |
United States, Ohio | |
Fairview Hospital | |
Cleveland, Ohio, United States, 44111 | |
Cleveland Clinic | |
Cleveland, Ohio, United States, 44195 | |
United States, Texas | |
University of Texas MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Brian M Ilfeld, MD, MS | University California San Diego |
Responsible Party: | Brian M. Ilfeld, MD, MS, Professor, University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT03461120 |
Other Study ID Numbers: |
Phantom pain PREVENTION (DoD) |
First Posted: | March 9, 2018 Key Record Dates |
Last Update Posted: | November 19, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
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 |
Phantom Limb Perceptual Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Pain, Postoperative Postoperative Complications Pathologic Processes |
Pain Anesthetics Anesthetics, Local Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |