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

Amputation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00667264
• Other study ID #: UCSD Phantom Pilot
• Secondary ID: GM077026
• Status: Completed
• Phase: N/A
• First received: April 24, 2008
• Last updated: June 26, 2012
• Start date: October 2008
• Est. completion date: December 2011

Study information

• Verified date: June 2012
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: December 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amputation
• Phantom Limb
• Stump Pain

Intervention

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.

Locations

Country	Name	City	State
United States	UCSD Medical Center	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Diego	National Institute of General Medical Sciences (NIGMS), Summit Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Physical Functioning · Brief Pain Inventory		pre-intervention, then days 1, 3, 8, 28, 84, and 365	No
Secondary	Nervous System Reorganization [if patient elected to participate in the MRI procedures] · MRI procedure		pre-intervention; and then 8 and 28 days post-intervention	No
Secondary	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	Yes