Homeopathy Assessment in Terms of the Consumption of Analgesics After Knee Ligamentoplasty
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Enrollment
- 165
- Locations
- 2
- Primary Endpoint
- Morphine consumption delivered by PCA between 0 and 24 hours after a knee ligamentoplasty
Study Overview
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.
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Morphine consumption delivered by PCA between 0 and 24 hours after a knee ligamentoplasty
Secondary Outcomes
- 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