Leg Amputation and Continuous Sciatic Nerve Block

NCT00427947 | Terminated Phase 3 DMC

• 2 other identifiers: 9440-052004-037
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Phantom Limb; Leg Amputation

Keywords

phantom limb pain; amputation; anesthetics, local; postoperative analgesia; ropivacaine; analgesia

Outcome Measures

Primary Outcomes (1)

• Total intravenous morphine consumption

  during the first 72 postoperative hours following leg (below knee) amputation

Secondary Outcomes (4)

• tolerance and adverse effects (myalgia, infection, adverse effects of local anaesthetics) of the popliteal sciatic catheter, in patients with ASA physical status 2 or 3

  during the 72 first postoperative hours and on the 7th postoperative day

• tolerance and adverse effects of morphine during the protocol in the 2 groups of patients

  during the first 72 postoperative hours

• incidence of stump pain and phantom limb pain, time of outbreak, intensity (VAS), characteristics (French version of the McGill Pain Questionnaire and DN4 qu

  1, 3, 6 and 12 months postoperative

• use of prosthesis

  1, 3, 6 and 12 months postoperative

Study Arms (2)

1

EXPERIMENTAL

Continuous sciatic nerve bloc : ropivacaine infusion

Drug: ropivacaine/placebo

2

PLACEBO COMPARATOR

Continuous sciatic nerve bloc : NaCl Infusion

Drug: ropivacaine/placebo

Interventions

ropivacaine/placebo DRUG

Continuous sciatic nerve bloc

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for leg amputation following arteritis
• ASA score: 2-3
• Informed consent obtained from the patient

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Département d'anesthésie réanimation I, Hopital Pellegrin, CHU de Bordeaux

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Phantom Limb; Agnosia

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Karine NOUETTE GAULAIN, Dr

  University Hospital, Bordeaux, France

  PRINCIPAL INVESTIGATOR

• Antoine BENARD, Dr

  university hospital, Bordeaux, France

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 26, 2007
• First Posted: January 29, 2007
• Study Start: December 1, 2006
• Primary Completion: April 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 29, 2009

Record last verified: 2009-12

Locations

FR (1)