Amputation Clinical Trial
Official title:
Ambulatory Continuous Peripheral Nerve Blocks for Treatment of Post-Amputation Phantom Limb and Stump Pain
Verified date | July 2019 |
Source | University of California, San Diego |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 2 |
Est. completion date | January 2010 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | All |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Naval Medical Center San Diego | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego |
United States,
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 | ||
Secondary | Physical Functioning · Brief Pain Inventory | pre-intervention, then days 1, 3, 8, 28, 84, and 365 | ||
Secondary | Emotional Functioning · Beck Depression Inventory | pre-intervention; and then day 28 and 365 post-intervention | ||
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 | ||
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 |
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