Leg Amputation and Continuous Sciatic Nerve Block

• Status: Terminated
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Analgesia following leg amputation is based on morphine administration. For elderly patients of ASA physical status 2 or 3, morphine sparing is possible when perinervous block techniques are used. Phantom limb pain complicates leg amputation in 50 to 80% of cases. Prevention of these pains has been studied in various clinical trials but the interest of perinervous block technique remains to be evaluated.

The purpose of the study is to evaluate the benefit of perioperative locoregional analgesia by ropivacaine via a popliteal sciatic catheter on intravenous morphine consumption during the 72 first postoperative hours following leg (below knee) amputation The study will be randomized, double blinded, controlled clinical trial and 84 patients undergoing leg amputation (below knee) will be included Patients will be divided into 2 groups: one group of patients who will benefit perioperative locoregional analgesia by ropivacaine via a popliteal sciatic catheter and morphine for analgesia and the other one who will benefit placebo through the catheter and morphine.

The investigators will evaluate the efficacy of the continuous popliteal sciatic nerve block in postoperative analgesia after leg amputation and prove the efficacy of a perioperative analgesia by continuous popliteal sciatic nerve block to prevent phantom limb pain after leg amputation in patients of ASA physical status 2 or 3.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bordeaux
• Treatments: Ropivacaine

Criteria

Inclusion Criteria:

• Patients scheduled for leg amputation following arteritis

• ASA score: 2-3

• Informed consent obtained from the patient

Exclusion Criteria:

• Patients involved in another clinical trial

• Post-infection OR post traumatic leg amputation

• Blood coagulation disorders

• Local anesthetic, morphine, or paracetamol allergy

• Local inflammatory signs

• Pregnant or breastfeeding women

• Patients with protective supervision