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

NCT00667264 | Completed

• 2 other identifiers: UCSD Phantom PilotGM077026
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation; Phantom Limb; Stump Pain

Keywords

pain; phantom limb; stump pain; catheter; nerve block; peripheral nerve block; ucsd; Post-amputation phantom limb or stump pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Active

ACTIVE COMPARATOR

3-7 days of perineural local anesthetic infusion

Procedure: perineural ropivacaine

Placebo

PLACEBO COMPARATOR

3-7 days of perineural normal saline infusion

Procedure: perineural ropivacaine

Interventions

perineural ropivacaine PROCEDURE

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.

Active; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• known hepatic or renal insufficiency
• allergy to the study medications
• possessing a contraindication to perineural catheter placement or perineural local anesthetic infusion

Sponsors & Collaborators

• University of California, San Diego: lead
• Summit Medical: collaborator
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

UCSD Medical Center

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Phantom Limb; Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Brian Ilfeld, M.D., M.S.

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, In Residence

Study Record Dates

• First Submitted: April 24, 2008
• First Posted: April 28, 2008
• Study Start: October 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 28, 2012

Record last verified: 2012-06

Locations

US (1)