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Pre-emptive Sciatic Bloc to Prevent Lower Limb Phantom Pain

This study has been completed.
Sponsor:
Information provided by:
Universitaire de Sherbrooke
ClinicalTrials.gov Identifier:
NCT00528463
First received: September 10, 2007
Last updated: February 1, 2010
Last verified: September 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Phantom Limb Pain
 Procedure: sciatic nerve block
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: a Prospective Case Series of Pre-emptive Pre-amputation Sciatic Nerve Block to Prevent Lower Limb Phantom Pain

Further study details as provided by Universitaire de Sherbrooke:

Primary Outcome Measures:
  • incidence of lower limb phantom pain [ Time Frame: 3 month post amputation ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: January 2005
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sciatic block
One arm, all patient studied received a block
 Procedure: 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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00528463

Locations
Canada, Quebec
CHU
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Universitaire de Sherbrooke
Investigators
Principal Investigator: ETIENNE DE MEDICIS, MD, MSC UNIVERSITE DE SHERBROOKE
  More Information

No publications provided

Responsible Party: Étienne de Médicis, CHUS
ClinicalTrials.gov Identifier: NCT00528463     History of Changes
Other Study ID Numbers: edm1
Study First Received: September 10, 2007
Last Updated: February 1, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by Universitaire de Sherbrooke:
Pre-emptive analgesia
Peripheral nerve block (sciatic)
phantom lomb pain

Additional relevant MeSH terms:
Phantom Limb
Perceptual Disorders
Neurobehavioral Manifestations
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013