Status:
COMPLETED
Optimized Perioperative Analgesia Reduces the Prevalence and the Intensity of Phantom Pain in Lower Limb Amputation
Lead Sponsor:
University of Patras
Conditions:
Phantom Limb Pain
Eligibility:
All Genders
18-82 years
Phase:
PHASE2
PHASE3
Brief Summary
Severe pre-amputation pain is associated with phantom pain development, and phantom pain models assign major importance to central and peripheral nervous system changes related to pre-amputation pain....
Detailed Description
In a prospective, randomized, double-blind trial, 65 patients undergoing elective lower limb amputation were assigned to one of five analgesic regimens. Patients in groups 1-4 had lumbar epidural cath...
Eligibility Criteria
Inclusion
- Age \>18, Visual Analog. Scale (VAS) pain score \>70mm which was frequent or continuous one week before scheduled major (above or below knee) amputation, and patient consent.
Exclusion
- No written patient consent
- Age \< 18 years
- Age \> 82 years
- Antiplatelet medication
- Mental status not acceptable
- Exclusion criteria were age \>85
- Emergency amputation
- Ipsilateral re-amputation
- Foot or toe amputation
- Inability to complete a detailed pain questionnaire
- History of chronic pain or substance abuse
- Active psychiatric disease requiring treatment
- Any contraindication to epidural catheter placement (anticoagulation, anti-platelet medications, previous lumbar spine surgery).
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00443404
Start Date
December 1 2003
End Date
May 1 2009
Last Update
November 7 2011
Active Locations (1)
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1
Pátrai, Greece