Ambulatory Continuous Peripheral Nerve Blocks for Treatment of Post-Amputation Phantom Limb and Stump Pain

Not Applicable

Completed

• Conditions: Amputation; Phantom Limb; Stump Pain
• Interventions: Procedure: perineural ropivacaine

• Registration Number: NCT00667264
• Lead Sponsor: University of California, San Diego

Brief Summary

Research study 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.

Detailed Description

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 Timeline

• Study First Submitted: 2008-04-24
• Study First Submitted QC: 2008-04-24
• Study First Posted: 2008-04-28
• Study Start: 2008-10
• Primary Completion: 2011-01
• Study Completion: 2011-12
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-26
• Last Update Posted: 2012-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active	perineural ropivacaine	3-7 days of perineural local anesthetic infusion
Placebo	perineural ropivacaine	3-7 days of perineural normal saline infusion

Primary Outcome Measures

Name	Time	Method
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	Week 4

Secondary Outcome Measures

Name	Time	Method
Physical Functioning · Brief Pain Inventory	pre-intervention, then days 1, 3, 8, 28, 84, and 365
Nervous System Reorganization [if patient elected to participate in the MRI procedures] · MRI procedure	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	Day 8, Day 28, Month 12

Trial Locations

Locations (1)

UCSD Medical Center; 🇺🇸 San Diego, California, United States