Homeopathy Assessment in Terms of the Consumption of Analgesics After Knee Ligamentoplasty

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Homeopathy Assessment in Terms of the Consumption of Analgesics After Knee Ligamentoplasty

Conditions
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Pain

Intervention / Treatment
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* Drug: Arnica montana, 5 CH
* Drug: Bryonia alba, 5 CH
* Drug: Hypericum perforatum, 5 CH
* Drug: Ruta graveolens, 3 DH


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ranging from 18 to 60 years. Patients who are candidates for a ligamentoplasty of the anterior cruciate ligament. Exclusion Criteria: Patients with corticoid and immunodepressor treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Arnica montana, 5 CH|nan|
|Drug: Bryonia alba, 5 CH|nan|
|Drug: Hypericum perforatum, 5 CH|nan|
|Drug: Ruta graveolens, 3 DH|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine consumption delivered by PCA between 0 and 24 hours after a knee ligamentoplasty |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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homeopathy, assessment, pain, ligamentoplasty