Ambulatory Continuous Peripheral Nerve Blocks for Treatment of Post-Amputation Phantom Limb and Stump Pain
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ClinicalTrials.gov Identifier: NCT00667264 |
Recruitment Status
:
Completed
First Posted
: April 28, 2008
Last Update Posted
: June 28, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Amputation Phantom Limb Stump Pain | Procedure: perineural ropivacaine | Not Applicable |
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 (Clinical Trial) |
Actual Enrollment : | 7 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Ambulatory Continuous Peripheral Nerve Blocks for Treatment of Post-Amputation Phantom Limb and Stump Pain |
Study Start Date : | October 2008 |
Actual Primary Completion Date : | January 2011 |
Actual Study Completion Date : | December 2011 |

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.
|
- 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 ]
- Physical Functioning · Brief Pain Inventory [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Day 8, Day 28, Month 12 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
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 |
First Posted: | April 28, 2008 Key Record Dates |
Last Update Posted: | June 28, 2012 |
Last Verified: | June 2012 |
Keywords provided by Brian M. Ilfeld, MD, MS, 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 Perceptual Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Pain, Postoperative Pain Postoperative Complications Pathologic Processes |
Signs and Symptoms Ropivacaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |