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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00307853 |
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Date of registration:
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27/03/2006 |
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Primary sponsor: |
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Public title:
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TRAUMEEL for Pain After Total Knee/Hip Arthroplasty
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Scientific 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. |
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Date of first enrolment:
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August 2008 |
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Target sample size:
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224 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00307853 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Israel
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Contacts
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Name:
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Menachem Oberbaum, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Shaare Zedek Medical Center, Jerusalem, Israel |
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Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Total Knee and Total Hip Arthroplasty
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Intervention(s)
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Drug: Traumeel S
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Other: Placebo
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Other: Traumeel S
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Primary Outcome(s)
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Cumulative 48-hour postoperative morphine consumption as consumed by the patient via the PCA device
[Time Frame: 48h]
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Secondary Outcome(s)
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AUC of NRS scores for days 14-17.
[Time Frame: 14-17d]
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Cumulative 24-hour postoperative morphine consumption as consumed by the patient via the PCA device
[Time Frame: 24h]
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Development of acute confusional state in the postoperative period
[Time Frame: 14-17d]
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ESR and hs-CPR at three and six days and six weeks
[Time Frame: 6d and 3weeks]
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IL-6 at three and six days
[Time Frame: 3 and 6d]
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Number of primary oral analgesic tablets ingested between days 14-17
[Time Frame: 14-17d]
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Post operative blood loss
[Time Frame: postoperative period]
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Safety of post operative treatment
[Time Frame: 6 weeks]
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WOMAC
[Time Frame: 6 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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