Naval Medical Center San Diego (NMCSD) - Ambulatory Continuous Peripheral Nerve Blocks for Treatment of Post-Amputation Phantom Limb and Stump Pain

This study has been terminated.
(No longer enrolling patients, not enough enrollment)
Sponsor:
Information provided by (Responsible Party):
Brian M. Ilfeld, MD, MS, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00768248
First received: October 7, 2008
Last updated: September 13, 2011
Last verified: September 2011
  Purpose

The purpose of this research study is 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.


Condition Intervention
Amputation
Phantom Limb
Stump Pain
Drug: perineural ropivacaine
Drug: normal saline (placebo)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ambulatory Continuous Peripheral Nerve Blocks for Treatment of Post-Amputation Phantom Limb and Stump Pain

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • 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 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physical Functioning · Brief Pain Inventory [ Time Frame: pre-intervention, then days 1, 3, 8, 28, 84, and 365 ] [ Designated as safety issue: No ]
  • Emotional Functioning · Beck Depression Inventory [ Time Frame: pre-intervention; and then day 28 and 365 post-intervention ] [ Designated as safety issue: No ]
  • Nervous System Reorganization [if patient elected to participate in the MRI procedures] · MRI procedure [ Time Frame: pre-intervention; and then 8 and 28 days post-intervention ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Day 8, Day 28, Month 12 ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: October 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active
3-7 days of perineural local anesthetic infusion
Drug: perineural ropivacaine
ropivacaine 0.4%; the basal rate will be set at 7 mL/h
Placebo Comparator: Placebo
3-7 days of perineural normal saline infusion
Drug: normal saline (placebo)
the basal rate will be set at 7 mL/h

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00768248

Locations
United States, California
Naval Medical Center San Diego
San Diego, California, United States, 92134
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Steven Hanling, M.D. United States Naval Medical Center, San Diego
  More Information

No publications provided

Responsible Party: Brian M. Ilfeld, MD, MS, Associate Professor, In Residence, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00768248     History of Changes
Other Study ID Numbers: NMCSD Phantom Pilot
Study First Received: October 7, 2008
Last Updated: September 13, 2011
Health Authority: United States: Federal Government

Keywords provided by University of California, San Diego:
pain
phantom limb
stump pain
catheter
nerve block
peripheral nerve block
NMCSD
Post-Amputation Phantom Limb or Stump Pain

Additional relevant MeSH terms:
Phantom Limb
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014