We hypothesize that Traumeel S is more effective than placebo in reducing 48-hour mean cumulative morphine consumption in patients scheduled for surgical correction of fracture of neck of hip. 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. Immediately after surgery, patients will receive an initial dose of morphine of 0.1mg/kg body weight. Patients will take the oral study medication for 21 days. Every four hours after surgery, patients will be asked to grade their pain on an NRS. Subsequent doses of morphine will be calculated based upon the patient's weight and current NRS, according to a preplanned scheme. Patients will be permitted to request additional morphine, beyond their calculated dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
224
homeopathic remedy
identical size, shape and taste of treatment medication
Dept. of Orthopedic Surgery, Shaare Zedek Medical Center
Jerusalem, Israel
Cumulative 48-hour postoperative morphine consumption
Time frame: 48h
Secondary: AUC of NRS scores for first 48 hrs.;
Time frame: 48h
AUC of NRS scores for days 14-17.;
Time frame: 17d
Composite measure of pain intensity and opiate consumption;
Time frame: 17d
Number of primary oral analgesic tablets ingested between days 14-17;
Time frame: 17d
ESR and hs-CPR at three and six days and six weeks;
Time frame: 42d
IL-6 at three and six days;
Time frame: 6d
Post operative blood loss;
Time frame: 48h
WOMAC;
Time frame: 17d
Safety of post operative treatment
Time frame: 17d
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