Clinical trial NCT00771862: Prevention of Phantom Limb and Stump Pain Using Ambulatory Continuous Peripheral Nerve Blocks: A Pilot Study
Official title: Prevention of Phantom Limb and Stump Pain Using Ambulatory Continuous Peripheral Nerve Blocks: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Amputation
Phantom Limb Pain
Stump Pain
Keywords: pain
amputation
phantom limb
stump pain
catheter
nerve block
peripheral nerve block
ucsd
post-amputation phantom limb or stump pain
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2008-10-15
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this research study is to determine if putting local anesthetic through one or two percutaneous catheters placed next to the nerves that go to an amputated limb will decrease long-term pain in the amputated limb.

Detailed description: Specific Aim 1: To determine if, compared with current and customary analgesia, the addition of multiple-day ambulatory continuous peripheral nerve blocks decrease the incidence and severity of post-amputation phantom limb and stump pain.

Hypothesis 1: Following upper or lower extremity amputation, the incidence of phantom limb and/or stump pain will be significantly decreased four weeks following multiple-day ambulatory continuous peripheral nerve blocks as compared with patients receiving standard-of-care treatment.

Hypothesis 2: Following upper or lower extremity amputation, the severity of phantom limb and/or stump pain will be significantly decreased four weeks following multiple-day ambulatory continuous peripheral nerve blocks as compared with patients receiving standard-of-care treatment (as measured on the 11-point numeric rating scale).

Eligibility criteria: Inclusion Criteria:

* undergoing unilateral surgical amputation of the upper or lower extremity including at least one metacarpal or metatarsal bone, respectively
* currently without phantom limb and/or stump pain in a previously-amputated limb
* ages 18 years or older
* desiring perineural infusion for up to 6 days
* willing to have an ambulatory infusion following hospital discharge

Exclusion Criteria:

* hepatic or renal failure
* allergy to the study medications
* pregnancy
* incarceration
* possessing a contraindication to perineural catheter placement or perineural local anesthetic infusion

Primary outcomes:
measure: The primary outcome measurement will be the difference in average NRS (as administered as part of the Brief Pain Inventory) at 4 weeks between the two treatment groups.
timeFrame: Week 4
Secondary outcomes:
measure: Pain and Physical functioning: Brief Pain Inventory (includes the 11-point numeric rating scale of pain intensity)
timeFrame: Preoperative, then days 3, 8, 28, 84, and 365
measure: Emotional Functioning: Beck Depression Inventory
timeFrame: Preoperative, then days 28 and 365
measure: The incidence of phantom limb and/or stump pain will be significantly decreased four weeks following multiple-day ambulatory continuous peripheral nerve blocks as compared with patients receiving standard-of-care treatment.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Medical Center
state: California
Study officials:
affiliation: University of California, San Diego
name: Brian Ilfeld, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References: