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Pre-emptive Sciatic Bloc to Prevent Lower Limb Phantom Pain

Primary Purpose

Phantom Limb Pain

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
sciatic nerve block
Sponsored by
Université de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Phantom Limb Pain focused on measuring Pre-emptive analgesia, Peripheral nerve block (sciatic), phantom lomb pain

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • CHU

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

sciatic block

Arm Description

One arm, all patient studied received a block

Outcomes

Primary Outcome Measures

incidence of lower limb phantom pain

Secondary Outcome Measures

Full Information

First Posted
September 10, 2007
Last Updated
February 1, 2010
Sponsor
Université de Sherbrooke
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1. Study Identification

Unique Protocol Identification Number
NCT00528463
Brief Title
Pre-emptive Sciatic Bloc to Prevent Lower Limb Phantom Pain
Official Title
a Prospective Case Series of Pre-emptive Pre-amputation Sciatic Nerve Block to Prevent Lower Limb Phantom Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Université de Sherbrooke

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phantom Limb Pain
Keywords
Pre-emptive analgesia, Peripheral nerve block (sciatic), phantom lomb pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sciatic block
Arm Type
Experimental
Arm Description
One arm, all patient studied received a block
Intervention Type
Procedure
Intervention Name(s)
sciatic nerve block
Intervention Description
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
Primary Outcome Measure Information:
Title
incidence of lower limb phantom pain
Time Frame
3 month post amputation

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ETIENNE DE MEDICIS, MD, MSC
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada

12. IPD Sharing Statement

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Pre-emptive Sciatic Bloc to Prevent Lower Limb Phantom Pain

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