NCT00528463

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2005

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 12, 2007

Completed
Last Updated

February 2, 2010

Status Verified

September 1, 2007

Enrollment Period

2.7 years

First QC Date

September 10, 2007

Last Update Submit

February 1, 2010

Conditions

Phantom Limb Pain

Keywords

Pre-emptive analgesiaPeripheral nerve block (sciatic)phantom lomb pain

Outcome Measures

Primary Outcomes (1)

  • incidence of lower limb phantom pain

    3 month post amputation

Study Arms (1)

sciatic block

EXPERIMENTAL

One arm, all patient studied received a block

Procedure: sciatic nerve block

Interventions

sciatic nerve blockPROCEDURE

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

sciatic block

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient scheduled for lower limb amputation

You may not qualify if:

  • Inability to consent
  • Contraindication to peripheral nerve block
  • Inability to perform the block
  • Inadequate time frame (less than 24 hours prior to surgery)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Phantom Limb

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPain, PostoperativePostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsPain

Study Officials

  • ETIENNE DE MEDICIS, MD, MSC

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 10, 2007

First Posted

September 12, 2007

Study Start

January 1, 2005

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

February 2, 2010

Record last verified: 2007-09

Locations

CA(1)