Total Knee and Total Hip Arthroplasty Clinical Trial
Official title:
A Randomised, Double - Blind, Placebo Controlled Clinical Trial to Assess the Efficacy of the Homeopathic Medication TRAUMEEL S in Controlling Pain After Total Knee and Total Hip Arthroplasty.
We hypothesize that Traumeel S is more effective than placebo in reducing 48-hour mean
cumulative morphine consumption following Total Knee or Hip Arthroplasty.
224 patients, meeting all inclusion and none of exclusion criteria, will be enrolled in the
trial. Patients will be randomized to receive either intraoperative injection and post
operative oral Traumeel S Tablets or placebo injection (normal saline) and indistinguishable
oral placebo tablets. Baseline measurements of relevant outcome measures will taken
preoperatively.
In the recovery room, the patient will begin to receive IV Dipyrone (Optalgin) 1000mg, for a
total of 4 doses during the first 24 hours postoperatively (1000 mg every 6 hours). Once
back in the ward, the patient will be connected to an IV Patient-Controlled Analgesia (PCA)
device, enabling the self-administration of morphine at a set dose of 1mg every 8 minutes,
should the patient require it. The PCA memory registers the time and dose, and the data will
be used later to evaluate post-operative pain.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment