We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00528463


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

Responsible Party: Étienne de Médicis, CHUS
ClinicalTrials.gov Identifier: NCT00528463     History of Changes
Other Study ID Numbers: edm1
First Submitted: September 10, 2007
First Posted: September 12, 2007
Last Update Posted: February 2, 2010
Last Verified: September 2007

Keywords provided by Université 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
Pain, Postoperative
Pain
Postoperative Complications
Pathologic Processes
Signs and Symptoms