TRAUMEEL for Pain After Fracture of Neck of Femur

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pain, Fracture of Neck of Femur

Intervention / Treatment
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* Drug: Traumeel S
* Drug: Placebo remedy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>TRAUMEEL S | Drug: Traumeel S<br>* homeopathic remedy<br>|
| Placebo Comparator: B<br>placebo remedy | Drug: Placebo remedy<br>* identical size, shape and taste of treatment medication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative 48-hour postoperative morphine consumption |  | 48h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary: AUC of NRS scores for first 48 hrs.; |  | 48h | 
| 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 | 
| IL-6 at three and six days; |  | 6d | 
| Post operative blood loss; |  | 48h | 
| WOMAC; |  | 17d | 
| Safety of post operative treatment |  | 17d | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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homeopathy, pain, traumeel s, Fracture of neck of femur, Surgical correction of fracture of neck of hip