Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00427947
Status:
TERMINATED
Last Update Posted:
2009-12-29
First Post:
2007-01-26
Brief Title:
Leg Amputation and Continuous Sciatic Nerve Block
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Continuous Popliteal Sciatic Nerve Block Interest in Postoperative Pain Management for Patients With Leg Amputation
Status:
TERMINATED
Status Verified Date:
2009-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPDAF
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2004-037 | None | None | None |