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

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.

Study Overview

• Status: Completed
• Conditions: Amputation; Phantom Limb; Stump Pain
• Intervention / Treatment: Procedure: perineural ropivacaine

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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92103
      • UCSD Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Active; 3-7 days of perineural local anesthetic infusion	Procedure: perineural ropivacaine; Subjects will be randomized to one of two groups: ropivacaine 0.4% or normal saline (placebo). The basal rate will be set at 7 mL/h.
PLACEBO_COMPARATOR: Placebo; 3-7 days of perineural normal saline infusion	Procedure: perineural ropivacaine; Subjects will be randomized to one of two groups: ropivacaine 0.4% or normal saline (placebo). The basal rate will be set at 7 mL/h.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: National Institute of General Medical Sciences (NIGMS); Summit Medical
• Investigators: Principal Investigator: Brian Ilfeld, M.D., M.S., University of California, San Diego

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (ACTUAL): January 1, 2011
• Study Completion (ACTUAL): December 1, 2011

Study Registration Dates

• First Submitted: April 24, 2008
• First Submitted That Met QC Criteria: April 24, 2008
• First Posted (ESTIMATE): April 28, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): June 28, 2012
• Last Update Submitted That Met QC Criteria: June 26, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: pain; nerve block; catheter; stump pain; phantom limb; peripheral nerve block; ucsd; Post-amputation phantom limb or stump pain
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Pain, Postoperative; Phantom Limb; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: UCSD Phantom Pilot; GM077026