Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
224 participants
INTERVENTIONAL
2011-01-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A
TRAUMEEL S
Traumeel S
homeopathic remedy
B
placebo remedy
Placebo remedy
identical size, shape and taste of treatment medication
Interventions
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Traumeel S
homeopathic remedy
Placebo remedy
identical size, shape and taste of treatment medication
Eligibility Criteria
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Inclusion Criteria
* Age over 18 years.
* Signature upon informed consent form
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Shaare Zedek Medical Center
OTHER
Responsible Party
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Shaare Zedek Medical Center,
Principal Investigators
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Menachem Oberbaum, MD
Role: PRINCIPAL_INVESTIGATOR
Shaare Zedek Medical Center, Jerusalem, Israel
Locations
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Dept. of Orthopedic Surgery, Shaare Zedek Medical Center
Jerusalem, , Israel
Countries
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Other Identifiers
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NoF 06 CTIL
Identifier Type: -
Identifier Source: org_study_id