Leg Amputation and Continuous Sciatic Nerve Block (CAPDAF)
Primary Purpose
Phantom Limb, Leg Amputation
Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
ropivacaine/placebo
Sponsored by
About this trial
This is an interventional treatment trial for Phantom Limb focused on measuring phantom limb pain, amputation, anesthetics, local, postoperative analgesia, ropivacaine, analgesia
Eligibility 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
Sites / Locations
- Département d'anesthésie réanimation I, Hopital Pellegrin, CHU de Bordeaux
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Continuous sciatic nerve bloc : ropivacaine infusion
Continuous sciatic nerve bloc : NaCl Infusion
Outcomes
Primary Outcome Measures
Total intravenous morphine consumption
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
tolerance and adverse effects of morphine during the protocol in the 2 groups of patients
incidence of stump pain and phantom limb pain, time of outbreak, intensity (VAS), characteristics (French version of the McGill Pain Questionnaire and DN4 qu
use of prosthesis
Full Information
NCT ID
NCT00427947
First Posted
January 26, 2007
Last Updated
December 28, 2009
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT00427947
Brief Title
Leg Amputation and Continuous Sciatic Nerve Block
Acronym
CAPDAF
Official Title
Continuous Popliteal Sciatic Nerve Block Interest in Postoperative Pain Management for Patients With Leg Amputation
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Terminated
Why Stopped
lack of patients
Study Start Date
December 2006 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Bordeaux
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phantom Limb, Leg Amputation
Keywords
phantom limb pain, amputation, anesthetics, local, postoperative analgesia, ropivacaine, analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Continuous sciatic nerve bloc : ropivacaine infusion
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Continuous sciatic nerve bloc : NaCl Infusion
Intervention Type
Drug
Intervention Name(s)
ropivacaine/placebo
Intervention Description
Continuous sciatic nerve bloc
Primary Outcome Measure Information:
Title
Total intravenous morphine consumption
Time Frame
during the first 72 postoperative hours following leg (below knee) amputation
Secondary Outcome Measure Information:
Title
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
Title
tolerance and adverse effects of morphine during the protocol in the 2 groups of patients
Time Frame
during the first 72 postoperative hours
Title
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
Title
use of prosthesis
Time Frame
1, 3, 6 and 12 months postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karine NOUETTE GAULAIN, Dr
Organizational Affiliation
University Hospital, Bordeaux, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antoine BENARD, Dr
Organizational Affiliation
university hospital, Bordeaux, France
Official's Role
Study Chair
Facility Information:
Facility Name
Département d'anesthésie réanimation I, Hopital Pellegrin, CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France
12. IPD Sharing Statement
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Leg Amputation and Continuous Sciatic Nerve Block
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