Prevention of Phantom Limb and Stump Pain Using Ambulatory Continuous Peripheral Nerve Blocks: A Pilot Study

Phase 4

Terminated

• Conditions: Stump Pain; Phantom Limb Pain; Amputation

• Registration Number: NCT00771862
• Lead Sponsor: University of California, San Diego

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).

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-14
• Study First Submitted QC: 2008-10-14
• Study First Posted: 2008-10-15
• Primary Completion: 2017-05-30
• Study Completion: 2017-05-30
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-15
• Last Update Posted: 2018-03-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.	Week 4

Secondary Outcome Measures

Name	Time	Method
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.	4 weeks
Pain and Physical functioning: Brief Pain Inventory (includes the 11-point numeric rating scale of pain intensity)	Preoperative, then days 3, 8, 28, 84, and 365
Emotional Functioning: Beck Depression Inventory	Preoperative, then days 28 and 365

Trial Locations

Locations (1)

UCSD Medical Center; 🇺🇸 San Diego, California, United States