Leg Amputation and Continuous Sciatic Nerve Block - Full Text View

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.

We 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 III

MedlinePlus related topics:

Anesthesia

ChemIDplus related topics:

Ropivacaine Ropivacaine Hydrochloride Ropivacaine monohydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Continuous Popliteal Sciatic Nerve Block Interest in Postoperative Pain Management for Patients With Leg Amputation

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:

To compare intravenous morphine consumption [ Time Frame: during the first 72 postoperative hours following leg (below knee) amputation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess 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 ]
To compare 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 ]
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 qu [ Time Frame: 1, 3, 6 and 12 months postoperative ] [ Designated as safety issue: No ]
To assess the possibility for the patients to use a prosthesis [ Time Frame: 1, 3, 6 and 12 months postoperative ] [ Designated as safety issue: No ]

Estimated Enrollment:	84
Study Start Date:	December 2006
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Continuous sciatic nerve bloc : ropivacaine infusion	Drug: ropivacaine/placebo Continuous sciatic nerve bloc
2: Placebo Comparator Continuous sciatic nerve bloc : NaCl Infusion	Drug: ropivacaine/placebo Continuous sciatic nerve bloc

Show Detailed Description

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

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

Contacts


Contact: Karine NOUETTE GAULAIN, Dr	33 (0) 5 56 79 55 14	karine.nouette-gaulain@chu-bordeaux.fr

Locations


France
	Département d'anesthésie réanimation I, Hopital Pellegrin, CHU de Bordeaux	Recruiting
	BORDEAUX, France, 33076
	Contact: Karine NOUETTE GAULAIN, Dr 33 (0) 5 56 79 55 14 karine.nouette-gaulain@chu-bordeaux.fr
	Sub-Investigator: Francois SZTARK, Pr
	Sub-Investigator: Philippe REVEL, Dr
	Sub-Investigator: Francoise MASSON, Dr
	Sub-Investigator: Dominique MIDY, Pr
	Sub-Investigator: Gérard SASSOUST, Dr
	Sub-Investigator: Bruno BROCHET, Pr

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

Responsible Party:	University Hospital, Bordeaux ( Jean-Pierre LEROY / Clinical Research and Innovation Director )
Study ID Numbers:	9440-05, 2004-037
First Received:	January 26, 2007
Last Updated:	August 20, 2008
ClinicalTrials.gov Identifier:	NCT00427947
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Bordeaux:

phantom limb pain

amputation

anesthetics, local

postoperative analgesia

ropivacaine

analgesia

Study placed in the following topic categories:

Signs and Symptoms

Ropivacaine

Neurologic Manifestations

Pain

Phantom Limb

Neurobehavioral Manifestations

Perceptual Disorders

Pain, Postoperative

Additional relevant MeSH terms:

Sensory System Agents

Therapeutic Uses

Physiological Effects of Drugs

Nervous System Diseases

Central Nervous System Depressants

Anesthetics

Peripheral Nervous System Agents

Central Nervous System Agents

Pharmacologic Actions

Anesthetics, Local

ClinicalTrials.gov processed this record on September 23, 2008

Sponsored by:	University Hospital, Bordeaux
Information provided by:	University Hospital, Bordeaux
ClinicalTrials.gov Identifier:	NCT00427947