Naval Medical Center San Diego (NMCSD) - Ambulatory Continuous Peripheral Nerve Blocks for Treatment of Post-Amputation Phantom Limb and Stump Pain

University of California, San Diego2 enrolled

Overview

The purpose of this research study is to determine if putting local anesthetic-or numbing medication-through one or two tiny tube(s) placed next to the nerves that go to an amputated limb will decrease phantom limb and/or stump pain.

Specific Aim 1: To determine if, compared with current standard-of-care treatment, the addition of an ambulatory continuous peripheral nerve block decreases post-amputation phantom limb and stump pain. Hypothesis 1: Following upper or lower extremity amputation, phantom limb and/or stump pain will be significantly decreased four weeks following a multiple-day ambulatory continuous peripheral nerve block as compared with patients receiving standard-of-care treatment (as measured on the 11-point numeric rating scale). Specific Aim 2: To investigate the possible relationship between the addition of a multiple-day ambulatory continuous peripheral nerve block to standard-of-care treatment of post-amputation phantom limb and/or stump pain and cortical reorganization. Hypothesis 2: Following upper or lower extremity amputation with subsequent phantom limb pain/sensation and/or stump pain, the addition of a multiple-day ambulatory continuous peripheral nerve block to standard-of-care treatment will result in cortical reorganization during and four-weeks following the perineural infusion (as measured by MRI).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Amputation Phantom Limb Stump Pain

Interventions

perineural ropivacaineDRUG

ropivacaine 0.4%; the basal rate will be set at 7 mL/h

normal saline (placebo)DRUG

the basal rate will be set at 7 mL/h

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * previous upper or lower limb amputation including at least one metacarpal or metatarsal bone, respectively * age 18 years or older * phantom limb and/or stump pain described as at least a 2 on the NRS for the previous week \[and pain occurring on a weekly basis over the previous month\] * willing to have an ambulatory perineural infusion for 6 days * willing to avoid additional "new" analgesic interventions from 4 weeks prior to at least 4 weeks following catheter placement, and preferably to 6 months following catheter placement * the availability of a "caretaker" who will transport the subject home following the procedure and remain with the subject for the first night of the infusion Exclusion Criteria: * known hepatic or renal insufficiency * allergy to the study medications * possessing a contraindication to perineural catheter placement or perineural local anesthetic infusion

Locations (1)

Naval Medical Center San Diego

San Diego, California, United States

Outcomes

Primary Outcomes

Primary Analysis Will Compare the Two Treatment Groups for the Phantom Limb/Stump Pain Change From Baseline to 4 Weeks Following the Initial Catheter Placement

Time frame: Week 4

Secondary Outcomes

Physical Functioning · Brief Pain Inventory

Time frame: pre-intervention, then days 1, 3, 8, 28, 84, and 365

Emotional Functioning · Beck Depression Inventory

Time frame: pre-intervention; and then day 28 and 365 post-intervention

Nervous System Reorganization [if Patient Elected to Participate in the MRI Procedures] · MRI Procedure

Time frame: pre-intervention; and then 8 and 28 days post-intervention

Pain · 11-point Numeric Rating Scale of Pain Intensity · Usage of Baseline and Rescue Analgesics in Previous 24 Hours · Patient Global Impression of Change Scale

Time frame: Day 8, Day 28, Month 12

Data from ClinicalTrials.gov

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