Pre-emptive Sciatic Bloc to Prevent Lower Limb Phantom Pain

Phantom Limb Pain Clinical Trial

Official title:

a Prospective Case Series of Pre-emptive Pre-amputation Sciatic Nerve Block to Prevent Lower Limb Phantom Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00528463
• Other study ID #: edm1
• Status: Completed
• Phase: Phase 4
• First received: September 10, 2007
• Last updated: February 1, 2010
• Start date: January 2005
• Est. completion date: September 2007

Study information

• Verified date: September 2007
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Phantom Limb
• Phantom Limb Pain

Intervention

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

Locations

Country	Name	City	State
Canada	CHU	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of lower limb phantom pain		3 month post amputation	No