Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00222365
Status:
TERMINATED
Last Update Posted:
2006-11-14
First Post:
2005-09-14
Brief Title:
Homeopathy Assessment in Terms of the Consumption of Analgesics After Knee Ligamentoplasty
Sponsor:
University Hospital Grenoble
Organization:
University Hospital Grenoble
Study Overview
Official Title:
Homeopathy Assessment in Terms of the Consumption of Analgesics After Knee Ligamentoplasty
Status:
TERMINATED
Status Verified Date:
2006-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an add-on double blind and randomised clinical trial with three groups a homeopathic group a placebo group and a temporal control group
The aim of this trial is to assess the effect of homeopathy on the consumption of morphine delivered by PCA patient control analgesia for 24 hours after a knee ligamentoplasty
The aim of this trial is to assess the effect of homeopathy on the consumption of morphine delivered by PCA patient control analgesia for 24 hours after a knee ligamentoplasty
Detailed Description:
We test the effectiveness of an homeopathic drug versus placebo and a temporal control group patient with no add-on treatment following orthopedic knee surgery
All patients have a PCA of morphine for 24 hours after surgery After this period they can take an oral tablet of morphine on request
Group A Patients with study treatment homeopathy allocation Double blind group with 70 patients
Group B Patients with placebo allocation Double blind group with 70 patients
Group C Temporal control group with patients who take only the morphine Open group with 25 patients
The total power 70 70 25 165 patients
Main Objective
To assess the effect of homeopathy in terms of morphine consumption delivered by PCA patient control analgesia for 24 hours after a knee ligamentoplasty
Secondary Objectives
To assess the effect of homeopathy in terms of total morphine consumption between H24 and H72 after a knee ligamentoplasty
To assess the effect of homeopathy on the pain perception using a analogical visual scale for 72 hours
To asses the placebo effect of the homeopathic treatment
Main Assessment Criterion
Morphine consumption delivered by PCA between 0 and 24 hours after knee ligamentoplasty
Secondary Assessment Criteria
Morphine consumption between 0 and 72 hours after ligamentoplasty
Pain assessment at H0 H4 H24 and H72 using 10 cm Analogical Visual Scale
Inclusion Criteria
age ranging from 18 to 60
patients candidates for a ligamentoplasty of the anterior cruciate ligament
Exclusion Criteria
patient with corticoid and immunodepressor treatment
All patients have a PCA of morphine for 24 hours after surgery After this period they can take an oral tablet of morphine on request
Group A Patients with study treatment homeopathy allocation Double blind group with 70 patients
Group B Patients with placebo allocation Double blind group with 70 patients
Group C Temporal control group with patients who take only the morphine Open group with 25 patients
The total power 70 70 25 165 patients
Main Objective
To assess the effect of homeopathy in terms of morphine consumption delivered by PCA patient control analgesia for 24 hours after a knee ligamentoplasty
Secondary Objectives
To assess the effect of homeopathy in terms of total morphine consumption between H24 and H72 after a knee ligamentoplasty
To assess the effect of homeopathy on the pain perception using a analogical visual scale for 72 hours
To asses the placebo effect of the homeopathic treatment
Main Assessment Criterion
Morphine consumption delivered by PCA between 0 and 24 hours after knee ligamentoplasty
Secondary Assessment Criteria
Morphine consumption between 0 and 72 hours after ligamentoplasty
Pain assessment at H0 H4 H24 and H72 using 10 cm Analogical Visual Scale
Inclusion Criteria
age ranging from 18 to 60
patients candidates for a ligamentoplasty of the anterior cruciate ligament
Exclusion Criteria
patient with corticoid and immunodepressor treatment
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