Homeopathy Assessment in Terms of the Consumption of Analgesics After Knee Ligamentoplasty
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.
|Pain||Drug: Arnica montana, 5 CH Drug: Bryonia alba, 5 CH Drug: Hypericum perforatum, 5 CH Drug: Ruta graveolens, 3 DH||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Homeopathy Assessment in Terms of the Consumption of Analgesics After Knee Ligamentoplasty|
- Morphine consumption delivered by PCA between 0 and 24 hours after a knee ligamentoplasty
- Morphine consumption between 0 and 72 hours after the ligamentoplasty
- Pain assessment at hour 0 (H0), H4, H24 and H72 with 10 cm Analogical Visual Scale
|Study Start Date:||December 2003|
|Estimated Study Completion Date:||May 2006|
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
- To assess the effect of homeopathy in terms of morphine consumption delivered by PCA (patient control analgesia) for 24 hours after a knee ligamentoplasty.
- 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
- age ranging from 18 to 60.
- patients candidates for a ligamentoplasty of the anterior cruciate ligament.
- patient with corticoid and immunodepressor treatment
Please refer to this study by its ClinicalTrials.gov identifier: NCT00222365
|University Hospital of Grenoble|
|Grenoble, France, 38043|
|Principal Investigator:||CRACOWSKI Jean-Luc, Dr||Clinical Trial Center|