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

University of California San Diego

Status and phase: Terminated; Phase 4

Conditions: Amputation; Phantom Limb Pain; Stump Pain

Treatments: Procedure: perineural ropivicaine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00771862

Phantom Pain Prevention PILOT

Details and patient eligibility

About

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.

Full 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).

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups, including a placebo group

1. standard care

Placebo Comparator group

Description:

1 day of perineural ropivacaine 0.2% infusion followed by 4-5 days of normal saline infusion.

Treatment:

Procedure: perineural ropivicaine

2: experimental care

Active Comparator group

Description:

4-5 days of perineural ropivacaine 0.4% infusion.

Treatment:

Procedure: perineural ropivicaine