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Sponsored by: |
Shaare Zedek Medical Center |
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Information provided by: | Shaare Zedek Medical Center |
ClinicalTrials.gov Identifier: | NCT00307853 |
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.
Condition | Intervention | Phase |
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Total Knee and Total Hip Arthroplasty |
Drug: Traumeel S Other: Traumeel S Other: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study |
Official Title: | 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. |
Estimated Enrollment: | 224 |
Study Start Date: | February 2008 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
TraumeelS
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Drug: Traumeel S
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.
Other: Traumeel S
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.
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Placebo: Placebo Comparator |
Other: Placebo
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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Menachem Oberbaum, MD | 972-2-6666395 | oberbaum@szmc.org.il |
Israel | |
Dept. of Orthopedic Surgery, Shaare Zedek Medical Center | Recruiting |
Jerusalem, Israel, 91031 | |
Contact: Menachem Oberbaum, M.D. 972-2-6666395 oberbaum@szmc.org.il |
Principal Investigator: | Menachem Oberbaum, MD | Shaare Zedek Medical Center, Jerusalem, Israel |
Responsible Party: | Shaare Zedek Medical Center ( Menachem Oberbaum, MD ) |
Study ID Numbers: | AP 06 |
Study First Received: | March 27, 2006 |
Last Updated: | September 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00307853 |
Health Authority: | Israel: Ministry of Health |
homeopathy pain traumeel s total knee arthroplasty total hip arthroplasty |
Pain |