Fracture of Neck of Femur, Pain
Conditions
Keywords
homeopathy, pain, traumeel s, Fracture of neck of femur, Surgical correction of fracture of neck of hip
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.
Interventions
DRUGTraumeel S
homeopathic remedy
DRUGPlacebo remedy
identical size, shape and taste of treatment medication
Sponsors
Shaare Zedek Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative 48-hour postoperative morphine consumption | 48h |
Secondary
| Measure | Time frame |
|---|---|
| AUC of NRS scores for days 14-17.; | 17d |
| Composite measure of pain intensity and opiate consumption; | 17d |
| Number of primary oral analgesic tablets ingested between days 14-17; | 17d |
| ESR and hs-CPR at three and six days and six weeks; | 42d |
| Secondary: AUC of NRS scores for first 48 hrs.; | 48h |
| Post operative blood loss; | 48h |
| WOMAC; | 17d |
| Safety of post operative treatment | 17d |
| IL-6 at three and six days; | 6d |
Countries
Israel
Outcome results
None listed