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

Sponsor:

Collaborators:

Summit Medical

National Institute of General Medical Sciences (NIGMS)

Information provided by (Responsible Party):

Brian M. Ilfeld, MD, MS, University of California, San Diego

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Amputation Phantom Limb Stump Pain	Procedure: perineural ropivacaine	Not Applicable

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).

Study Design


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

Resource links provided by the National Library of Medicine

Drug Information available for: Ropivacaine monohydrochloride

U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

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 ]

Secondary Outcome Measures :

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 ]

Eligibility Criteria

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

Information from the National Library of Medicine

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

Locations


United States, California
UCSD Medical Center
San Diego, California, United States, 92103

Sponsors and Collaborators

University of California, San Diego

Summit Medical

National Institute of General Medical Sciences (NIGMS)

Investigators


Principal Investigator:	Brian Ilfeld, M.D., M.S.	University of California, San Diego

More Information


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

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