Leg Amputation and Continuous Sciatic Nerve Block (CAPDAF)

This study has been terminated.
(lack of patients)
Sponsor:
Information provided by:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00427947
First received: January 26, 2007
Last updated: December 28, 2009
Last verified: December 2009
  Purpose

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.


Condition Intervention Phase
Phantom Limb
Leg Amputation
Drug: ropivacaine/placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Continuous Popliteal Sciatic Nerve Block Interest in Postoperative Pain Management for Patients With Leg Amputation

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Total intravenous morphine consumption [ Time Frame: during the first 72 postoperative hours following leg (below knee) amputation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: during the 72 first postoperative hours and on the 7th postoperative day ] [ Designated as safety issue: Yes ]
  • tolerance and adverse effects of morphine during the protocol in the 2 groups of patients [ Time Frame: during the first 72 postoperative hours ] [ Designated as safety issue: Yes ]
  • incidence of stump pain and phantom limb pain, time of outbreak, intensity (VAS), characteristics (French version of the McGill Pain Questionnaire and DN4 qu [ Time Frame: 1, 3, 6 and 12 months postoperative ] [ Designated as safety issue: No ]
  • use of prosthesis [ Time Frame: 1, 3, 6 and 12 months postoperative ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: December 2006
Study Completion Date: December 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Continuous sciatic nerve bloc : ropivacaine infusion
Drug: ropivacaine/placebo
Continuous sciatic nerve bloc
Placebo Comparator: 2
Continuous sciatic nerve bloc : NaCl Infusion
Drug: ropivacaine/placebo
Continuous sciatic nerve bloc

  Hide Detailed Description

Detailed Description:

Introduction:

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. Indeed, per operative placement of a perinervous catheter by the surgeon allows a morphine consumption decrease of about 30%. Nevertheless, the interest of a sciatic block providing analgesia in the tibial and fibular territories has still to be assessed in this indication.

Phantom limb pain complicates leg amputation in 50 to 80% of cases. Risk factors of this complication are numerous, from central or peripheral origin. Phantom limb pain postpones patients' social and professional rehabilitation, and results in an increased medical consumption. Prevention of these pains has been studied in various clinical trials, and results need confirmation. Thus, epidural analgesia alone does not decrease the long term incidence of phantom limb pain.

Objectives:

Primary : To compare intravenous morphine consumption during the 72 first postoperative hours following leg (below knee) amputation of patients randomly assigned in two groups. One group benefit from perioperative locoregional analgesia by ropivacaine via a popliteal sciatic catheter, the other group is given placebo through the catheter.

Secondary :

  • To assess tolerance and adverse effects (myalgia, infection, adverse effects of local anaesthetics) of the popliteal sciatic catheter during the 72 first postoperative hours and on the 7th postoperative day, in patients with ASA physical status 2 or 3
  • To compare tolerance and adverse effects of morphine during the protocol in the 2 groups of patients
  • To assess the long term effects of the preoperative continuous popliteal sciatic nerve block: incidence of stump pain and phantom limb pain, time of outbreak, intensity (VAS), characteristics (French version of the McGill Pain Questionnaire and DN4 questionnaire), and the analgesic consumption over a year.
  • To assess the possibility for the patients to use a prosthesis

Population:

Eighty four patients scheduled for leg amputation (below knee), randomly allocated in 2 groups of forty patients, according to the type of analgesia. Patients were enrolled in the general and vascular surgery unit, CHU (University Hospital) Pellegrin Bordeaux.

Methods:

Randomised clinical trial, with two parallel groups, with direct individual benefit, double-blinded, realised on a population of patients undergoing leg amputation, comparing different clinical parameters of postoperative pain evaluation, and outbreak of phantom limb pain according to the group of analgesia.

  • One group of patients with locoregional analgesia associated with morphine administration (assessed treatment)
  • One group of patients with morphine analgesia only (reference treatment). Patients will be followed for one year. This study will last 3 years in a general and vascular surgery unit, inclusion will be realised during 34 months by anaesthetists and surgeons, an extension of this study for one year will be done with the objective of a cohort follow-up.

Statistical analysis will be done with intention to treat.

Anticipated results:

To prove the efficacy of the continuous popliteal sciatic nerve block in postoperative analgesia after leg amputation.

To 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00427947

Locations
France
Département d'anesthésie réanimation I, Hopital Pellegrin, CHU de Bordeaux
Bordeaux, France, 33076
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Karine NOUETTE GAULAIN, Dr University Hospital, Bordeaux, France
Study Chair: Antoine BENARD, Dr university hospital, Bordeaux, France
  More Information

No publications provided

Responsible Party: Jean-Pierre LEROY / Clinical Research and Innovation Director, University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00427947     History of Changes
Other Study ID Numbers: 9440-05, 2004-037
Study First Received: January 26, 2007
Last Updated: December 28, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
phantom limb pain
amputation
anesthetics, local
postoperative analgesia
ropivacaine
analgesia

Additional relevant MeSH terms:
Phantom Limb
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Pain
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014