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

Pain Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

• NCT number: NCT00222365
• Study type: Interventional
• Source: University Hospital, Grenoble
• Status: Terminated
• Phase: Phase 3
• Start date: December 2003
• Completion date: May 2006