TRAUMEEL for Pain After Total Knee/Hip Arthroplasty

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 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.

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 Pain After Total Knee and Total Hip Arthroplasty.

Conditions
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Total Knee and Total Hip Arthroplasty

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of either sex undergoing unilateral THAP or TKAP. 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 leg. 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: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>TraumeelS | Drug: Traumeel S<br>* All patients will receive an intra-operative injection of either Traumeel S or placebo solution. Afterwards, verum or indistinguishable placebo tablets, PO, two tablets five times daily from day 0 to 6 post-operatively, and two tablets three times daily from day 7 until day 21. To the extent possible, administration of tablets should be equally spaced between morning and evening (e.g. every 6 hours) at the same time every day.<br>Other: Traumeel S<br>* All patients will receive an intra-operative injection of either Traumeel S or placebo solution. Afterwards, verum or indistinguishable placebo tablets, PO, two tablets five times daily from day 0 to 6 post-operatively, and two tablets three times daily from day 7 until day 21. To the extent possible, administration of tablets should be equally spaced between morning and evening (e.g. every 6 hours) at the same time every day.<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* All patients will receive an intra-operative injection of either Traumeel S or placebo solution. Afterwards, verum or indistinguishable placebo tablets, PO, two tablets five times daily from day 0 to 6 post-operatively, and two tablets three times daily from day 7 until day 21. To the extent possible, administration of tablets should be equally spaced between morning and evening (e.g. every 6 hours) at the same time every day.<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 as consumed by the patient via the PCA device |  | 48h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC of NRS scores for days 14-17. |  | 14-17d | 
| Cumulative 24-hour postoperative morphine consumption as consumed by the patient via the PCA device |  | 24h | 
| Number of primary oral analgesic tablets ingested between days 14-17 |  | 14-17d | 
| ESR and hs-CPR at three and six days and six weeks |  | 6d and 3weeks | 
| IL-6 at three and six days |  | 3 and 6d | 
| Post operative blood loss |  | postoperative period | 
| WOMAC |  | 6 weeks | 
| Safety of post operative treatment |  | 6 weeks | 
| Development of acute confusional state in the postoperative period |  | 14-17d | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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homeopathy, pain, traumeel s, total knee arthroplasty, total hip arthroplasty