Clinical trial NCT00768248: Naval Medical Center San Diego (NMCSD) - Ambulatory Continuous Peripheral Nerve Blocks for Treatment of Post-Amputation Phantom Limb and Stump Pain
Official title: Ambulatory Continuous Peripheral Nerve Blocks for Treatment of Post-Amputation Phantom Limb and Stump Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Amputation
Phantom Limb
Stump Pain
Keywords: pain
phantom limb
stump pain
catheter
nerve block
peripheral nerve block
NMCSD
Post-Amputation Phantom Limb or Stump Pain
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2008-10-08
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: 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
timeFrame: Week 4
Secondary outcomes:
measure: Physical Functioning · Brief Pain Inventory
timeFrame: pre-intervention, then days 1, 3, 8, 28, 84, and 365
measure: Emotional Functioning · Beck Depression Inventory
timeFrame: pre-intervention; and then day 28 and 365 post-intervention
measure: Nervous System Reorganization [if Patient Elected to Participate in the MRI Procedures] · MRI Procedure
timeFrame: pre-intervention; and then 8 and 28 days post-intervention
measure: 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
timeFrame: Day 8, Day 28, Month 12
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
Study officials:
affiliation: United States Naval Medical Center, San Diego
name: Steven Hanling, M.D.
role: PRINCIPAL_INVESTIGATOR
References: