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Pre-emptive Sciatic Bloc to Prevent Lower Limb Phantom Pain

This study has been completed.
Sponsor:
Information provided by:
Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT00528463
First received: September 10, 2007
Last updated: February 1, 2010
Last verified: September 2007
  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 Université 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528463

Locations
Canada, Quebec
CHU
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Université 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 Université de Sherbrooke:
Pre-emptive analgesia
Peripheral nerve block (sciatic)
phantom lomb pain

Additional relevant MeSH terms:
Phantom Limb
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Pain
Pain, Postoperative
Pathologic Processes
Perceptual Disorders
Postoperative Complications
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014