Ambulatory Continuous Peripheral Nerve Blocks for Treatment of Post-Amputation Phantom Limb and Stump Pain
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Amputation Phantom Limb Stump Pain |
Procedure: perineural ropivacaine |
| 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 |
- 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 ]
- Physical Functioning · Brief Pain Inventory [ Time Frame: pre-intervention, then days 1, 3, 8, 28, 84, and 365 ] [ 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: Yes ]
| Enrollment: | 7 |
| Study Start Date: | October 2008 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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 |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00667264
| United States, California | |
| UCSD Medical Center | |
| San Diego, California, United States, 92103 | |
| Principal Investigator: | Brian Ilfeld, M.D., M.S. | University of California, 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: | NCT00667264 History of Changes |
| Other Study ID Numbers: | UCSD Phantom Pilot, GM077026 |
| Study First Received: | April 24, 2008 |
| Last Updated: | June 26, 2012 |
| 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 ucsd Post-amputation phantom limb or stump pain |
Additional relevant MeSH terms:
|
Phantom Limb Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain |
Pain, Postoperative Pathologic Processes Perceptual Disorders Postoperative Complications Signs and Symptoms |
ClinicalTrials.gov processed this record on February 27, 2015