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

Overview

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.

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

Conditions

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Eligibility

Locations (1)

Outcomes