Prevention of Phantom Limb and Stump Pain Using Ambulatory Continuous Peripheral Nerve Blocks: A Pilot Study

Phase 4TerminatedNCT00771862

University of California, San Diego16 enrolled

Overview

The purpose of this research study is to determine if putting local anesthetic through one or two percutaneous catheters placed next to the nerves that go to an amputated limb will decrease long-term pain in the amputated limb.

Specific Aim 1: To determine if, compared with current and customary analgesia, the addition of multiple-day ambulatory continuous peripheral nerve blocks decrease the incidence and severity of post-amputation phantom limb and stump pain. Hypothesis 1: Following upper or lower extremity amputation, the incidence of phantom limb and/or stump pain will be significantly decreased four weeks following multiple-day ambulatory continuous peripheral nerve blocks as compared with patients receiving standard-of-care treatment. Hypothesis 2: Following upper or lower extremity amputation, the severity of phantom limb and/or stump pain will be significantly decreased four weeks following multiple-day ambulatory continuous peripheral nerve blocks as compared with patients receiving standard-of-care treatment (as measured on the 11-point numeric rating scale).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Amputation Phantom Limb Pain Stump Pain

Interventions

perineural ropivicainePROCEDURE

Subjects will be randomized to one of two groups: ropivicaine 0.2% infusion for days 0-1 then infusion with normal saline (placebo) for days 1 through catheter removal (POD 4 or 5) or ropivicaine 0.4% infusion for day 0 through catheter removal (POD 4 or 5). The infusion rate will be set at 7-11 mL/h.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * undergoing unilateral surgical amputation of the upper or lower extremity including at least one metacarpal or metatarsal bone, respectively * currently without phantom limb and/or stump pain in a previously-amputated limb * ages 18 years or older * desiring perineural infusion for up to 6 days * willing to have an ambulatory infusion following hospital discharge Exclusion Criteria: * hepatic or renal failure * allergy to the study medications * pregnancy * incarceration * possessing a contraindication to perineural catheter placement or perineural local anesthetic infusion

Locations (1)

UCSD Medical Center

San Diego, California, United States

Outcomes

Primary Outcomes

The primary outcome measurement will be the difference in average NRS (as administered as part of the Brief Pain Inventory) at 4 weeks between the two treatment groups.

Time frame: Week 4

Secondary Outcomes

Pain and Physical functioning: Brief Pain Inventory (includes the 11-point numeric rating scale of pain intensity)

Time frame: Preoperative, then days 3, 8, 28, 84, and 365

Emotional Functioning: Beck Depression Inventory

Time frame: Preoperative, then days 28 and 365

The incidence of phantom limb and/or stump pain will be significantly decreased four weeks following multiple-day ambulatory continuous peripheral nerve blocks as compared with patients receiving standard-of-care treatment.

Time frame: 4 weeks

Data from ClinicalTrials.gov

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