Comparative study of two anesthetic techniques to prevent phantom pain after leg amputatio

• Conditions: Phantom limb pain following amputation of the lower leg due to critical limb ischemia.; MedDRA version: 16.1Level: LLTClassification code 10004227Term: Below knee amputationSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2013-000875-33-ES
• Lead Sponsor: Academic Medical Center, University of Amsterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-17
• Last Update Posted: 14 July 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Patients undergoing elective transtibial amputation for peripheral vascular disease, age over 18 years, ASA* status II to IV.
*ASA American Society of Anesthesiology.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

Exclusion Criteria

- contraindication to peripheral regional anesthesia
- confirmed allergy to local anesthetics
- prior amputation resulting in current phantom limb pain
- severe psychiatric disease
- pregnancy or breastfeeding status
- amputation for tumour surgery
- traumatic amputation and
- inability to give written and informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified