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

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

Interventions

DRUG

Experimental continuous peripheral nerve blocks

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

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

Sponsors & Collaborators

• United States Department of Defense

  collaborator FED

• United States Naval Medical Center, San Diego

  collaborator FED

• The Cleveland Clinic

  collaborator OTHER

• Walter Reed National Military Medical Center

  collaborator FED

• Johns Hopkins University

  collaborator OTHER

• Wake Forest University Health Sciences

  collaborator OTHER

• Boston VA

  collaborator UNKNOWN

• Massachusetts General Hospital

  collaborator OTHER

• Brigham and Women's Hospital

  collaborator OTHER

• University of California, San Diego

  lead OTHER

Principal Investigators

• Brian M Ilfeld, MD, MS · University California San Diego

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-03-23

Primary Completion

2026-08-18

Completion

2026-11-18

FDA Drug

Yes

Countries

• United States

Study Locations