Clinical trial NCT00307905: TRAUMEEL for Pain After Fracture of Neck of Femur
Official title: A Randomised, Double - Blind, Placebo Controlled Clinical Trial to Assess the Efficacy of the Homeopathic Medication TRAUMEEL S in Controlling Post-operative Pain After Fracture of Neck of Femur
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Pain
Fracture of Neck of Femur
Keywords: homeopathy
pain
traumeel s
Fracture of neck of femur
Surgical correction of fracture of neck of hip
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2006-03-28
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients of either sex undergoing surgical correction of unilateral fracture of neck of hip.
* Age over 18 years.
* Signature upon informed consent form

Exclusion Criteria:

* Participation in another clinical trial within 4 weeks prior to enrollment.
* Refused to give verbal consent to the telephone interviews
* Impossibility to be reached during the 14-17 days post operative
* Inability to comply with the study protocol for any other reason
* Previous major surgical procedure on ipsilateral hip.
* Current use of analgesics for any other reason.
* A history of chronic pain syndrome.
* Abused legal or illicit drug use.
* Hypersensitivity to botanicals of the Compositae family
* Known sensitivity to paracetamol, codeine or tramadol.

Primary outcomes:
measure: Cumulative 48-hour postoperative morphine consumption
timeFrame: 48h
Secondary outcomes:
measure: Secondary: AUC of NRS scores for first 48 hrs.;
timeFrame: 48h
measure: AUC of NRS scores for days 14-17.;
timeFrame: 17d
measure: Composite measure of pain intensity and opiate consumption;
timeFrame: 17d
measure: Number of primary oral analgesic tablets ingested between days 14-17;
timeFrame: 17d
measure: ESR and hs-CPR at three and six days and six weeks;
timeFrame: 42d
measure: IL-6 at three and six days;
timeFrame: 6d
measure: Post operative blood loss;
timeFrame: 48h
measure: WOMAC;
timeFrame: 17d
measure: Safety of post operative treatment
timeFrame: 17d
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Dept. of Orthopedic Surgery, Shaare Zedek Medical Center
Study officials:
affiliation: Shaare Zedek Medical Center, Jerusalem, Israel
name: Menachem Oberbaum, MD
role: PRINCIPAL_INVESTIGATOR
References: