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Pre-emptive Sciatic Bloc to Prevent Lower Limb Phantom Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00528463
First Posted: September 12, 2007
Last Update Posted: February 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Université de Sherbrooke
September 10, 2007
September 12, 2007
February 2, 2010
January 2005
September 2007   (Final data collection date for primary outcome measure)
incidence of lower limb phantom pain [ Time Frame: 3 month post amputation ]
Same as current
Complete list of historical versions of study NCT00528463 on ClinicalTrials.gov Archive Site
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Pre-emptive Sciatic Bloc to Prevent Lower Limb Phantom Pain
a Prospective Case Series of Pre-emptive Pre-amputation Sciatic Nerve Block to Prevent Lower Limb Phantom Pain
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.
Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Phantom Limb Pain
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
Experimental: sciatic block
One arm, all patient studied received a block
Intervention: Procedure: sciatic nerve block
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
September 2007
September 2007   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00528463
edm1
No
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Étienne de Médicis, CHUS
Université de Sherbrooke
Not Provided
Principal Investigator: ETIENNE DE MEDICIS, MD, MSC Université de Sherbrooke
Université de Sherbrooke
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP