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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2017-05-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Amputation Phantom Limb Pain Stump Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1. standard care

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

Group Type PLACEBO_COMPARATOR

perineural ropivicaine

Intervention Type PROCEDURE

Subjects will be randomized to one of two groups: ropivicaine 0.2% infusion for days 0-1 then infusion with normal saline (placebo) for days 1 through catheter removal (POD 4 or 5) or ropivicaine 0.4% infusion for day 0 through catheter removal (POD 4 or 5). The infusion rate will be set at 7-11 mL/h.

2: experimental care

4-5 days of perineural ropivacaine 0.4% infusion.

Group Type ACTIVE_COMPARATOR

perineural ropivicaine

Intervention Type PROCEDURE

Subjects will be randomized to one of two groups: ropivicaine 0.2% infusion for days 0-1 then infusion with normal saline (placebo) for days 1 through catheter removal (POD 4 or 5) or ropivicaine 0.4% infusion for day 0 through catheter removal (POD 4 or 5). The infusion rate will be set at 7-11 mL/h.

Interventions

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perineural ropivicaine

Subjects will be randomized to one of two groups: ropivicaine 0.2% infusion for days 0-1 then infusion with normal saline (placebo) for days 1 through catheter removal (POD 4 or 5) or ropivicaine 0.4% infusion for day 0 through catheter removal (POD 4 or 5). The infusion rate will be set at 7-11 mL/h.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No