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

NCT03461120 | Active Not Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: Phantom pain PREVENTION (DoD)
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 8

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.

Conditions

Lower Extremity Surgical Amputation; Post-amputation Phantom Limb Pain

Outcome Measures

Primary Outcomes (1)

• Locomotor Capabilities Index-5

  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.

  Postoperative Month 9

Secondary Outcomes (13)

• Locomotor Capabilities Index-5

  Baseline; Months 6 and 12

• World Health Organization Disability Assessment Schedule 2.0

  Baseline, Months 1, 3, 6, 9, and 12

• Beck Depression Inventory

  Baseline and Month 12

• Phantom limb pain

  Baseline, postoperative days 1, 2 and 8; Months 1, 3, 6, 9, and 12

• Residual limb pain

  Baseline, postoperative days 1, 2 and 8; Months 1, 3, 6, 9, and 12

Study Arms (2)

Treatment

EXPERIMENTAL

Bupivacaine 0.3% \[or ropivacaine 0.5%\] infusion for 7 days via femoral and sciatic perineural catheters

Drug: Experimental continuous peripheral nerve blocks

Control

OTHER

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

Drug: Control continuous peripheral nerve blocks

Interventions

Experimental continuous peripheral nerve blocks DRUG

Bupivacaine 0.3% \[or ropivacaine 0.5%\] infusions for 7 days via femoral and sciatic perineural catheters

Also known as: Experimental perineural local anesthetic infusion

Treatment

Control continuous peripheral nerve blocks DRUG

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

Also known as: Control perineural local anesthetic infusion

Control

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• United States Department of Defense: collaborator
• United States Naval Medical Center, San Diego: collaborator
• The Cleveland Clinic: collaborator
• Walter Reed National Military Medical Center: collaborator
• Johns Hopkins University: collaborator
• Wake Forest University Health Sciences: collaborator
• Boston VA: collaborator
• Massachusetts General Hospital: collaborator
• Brigham and Women's Hospital: collaborator

Study Sites (8)

University California San Diego

San Diego, California, 92103, United States

Location

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

Mass. General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Boston VA

Boston, Massachusetts, 02130, United States

Location

Fairview Hospital

Cleveland, Ohio, 44111, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Study Officials

• Brian M Ilfeld, MD, MS

  University California San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The only individuals aware of treatment assignment will be the Investigational Drug Service pharmacists who prepare the treatment infusate
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 4, 2018
• First Posted: March 9, 2018
• Study Start: March 23, 2018
• Primary Completion (Estimated): August 18, 2026
• Study Completion (Estimated): November 18, 2026
• Last Updated: October 20, 2025

Record last verified: 2025-10

Locations

US (8)