Prospective, double-blind, randomised trial to assess the efficacy of continuous sciatic/posterior tibial nerve blockade via a neural sheath catheter in lower limb amputees - bupivacaine phantom pai

Phase 1

• Conditions: Stump and phantom limb pain after lower limb amputation; MedDRA version: 9.1Level: LLTClassification code 10056238Term: Phantom pain; MedDRA version: 9.1Level: LLTClassification code 10054711Term: Postoperative pain

• Registration Number: EUCTR2007-000619-27-GB
• Lead Sponsor: niversity Hospitals of Leicester NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-05-15
• Study Completion: 2013-04-30
• Last Update Posted: 25 May 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Patients admitted to our vascular unit requiring a below or above knee amputation irrespective of aetiology.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients not considered for surgical intervention.
2. Patients who are deemed unfit to undergo surgery under general anaesthesia.
3. Patients unable to operate a Patient-controlled analgesia device or cooperate with evaluation of pain scores e.g. those with confusional states.
4. Patients unwilling to consent
5. Allergy to any study medication

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To establish the effects of continuous peri- and post-operative sciatic/posterior tibial nerve blockade using a levobupivacaine infusion via a neural sheath catheter on late stump pain, phantom limb sensations and phantom limb pain.;Secondary Objective: To assess the effect of this technique on early postoperative pain and morphine requirements.<br><br>To ascertain the late effects on mood, physical disability and quality of life<br>;Primary end point(s): 1. Stump pain scores, phantom pain scores and non-painful phantom sensation at 12 months after surgery <br>2. The presence or absence of allodynia at the stump site at 12 months after surgery <br>