Pre-emptive Sciatic Bloc to Prevent Lower Limb Phantom Pain

NCT ID: NCT00528463

Last Updated: 2010-02-02

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2007-09-30

Brief Summary

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Phantom limb pain is a complication of amputation. Although pre-empitve epidural analgesia was once thought to prevent such a com plication, recent studies did not demonstrate this. Peripheral blocks are more powerful then epidurals, and can even influence somatotropic representation in the brain. This a prospective case series in which the investigators hope to show a decrease, against historical control, of the incidence of post-operative amputation lower limb phantom pain. The investigators established the block at least 24 hours pre-operative and continue it for at least 2 days. Patient are followed daily for the 1st 3 days and then up to 3 month for the incidence of phantom limb pain. The investigators hope to recruit 30 patients.

Detailed Description

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Conditions

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Phantom Limb Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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sciatic block

One arm, all patient studied received a block

Group Type EXPERIMENTAL

sciatic nerve block

Intervention Type PROCEDURE

Sciatic nerve block, Labatt approach, with a stimuplex needle and catheter. Once localized, a bolus of 20 mL ropivacaine 1,0% is given through the catheter and is followed by a perfusion of ropivacaine 0,2% 6-10 mL/hre for at least 24 hours pre-op and 48 hours post-op

Interventions

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sciatic nerve block

Sciatic nerve block, Labatt approach, with a stimuplex needle and catheter. Once localized, a bolus of 20 mL ropivacaine 1,0% is given through the catheter and is followed by a perfusion of ropivacaine 0,2% 6-10 mL/hre for at least 24 hours pre-op and 48 hours post-op

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patient scheduled for lower limb amputation

Exclusion Criteria

* Inability to consent
* Contraindication to peripheral nerve block
* Inability to perform the block
* Inadequate time frame (less than 24 hours prior to surgery)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

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CHUS

Principal Investigators

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ETIENNE DE MEDICIS, MD, MSC

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke

Locations

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CHU

Sherbrooke, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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edm1

Identifier Type: -

Identifier Source: org_study_id

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