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Trial record 56 of 424 for:    shaare zedek

TRAUMEEL for Pain After Total Knee/Hip Arthroplasty

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ClinicalTrials.gov Identifier: NCT00307853
Recruitment Status : Terminated (lack of patients)
First Posted : March 28, 2006
Last Update Posted : October 20, 2009
Sponsor:
Information provided by:
Shaare Zedek Medical Center

Tracking Information
First Submitted Date  ICMJE March 27, 2006
First Posted Date  ICMJE March 28, 2006
Last Update Posted Date October 20, 2009
Study Start Date  ICMJE August 2008
Estimated Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2008)
Cumulative 48-hour postoperative morphine consumption as consumed by the patient via the PCA device [ Time Frame: 48h ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 27, 2006)
Cumulative 48-hour postoperative morphine consumption
Change History Complete list of historical versions of study NCT00307853 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2008)
  • AUC of NRS scores for days 14-17. [ Time Frame: 14-17d ]
  • Cumulative 24-hour postoperative morphine consumption as consumed by the patient via the PCA device [ Time Frame: 24h ]
  • Number of primary oral analgesic tablets ingested between days 14-17 [ Time Frame: 14-17d ]
  • ESR and hs-CPR at three and six days and six weeks [ Time Frame: 6d and 3weeks ]
  • IL-6 at three and six days [ Time Frame: 3 and 6d ]
  • Post operative blood loss [ Time Frame: postoperative period ]
  • WOMAC [ Time Frame: 6 weeks ]
  • Safety of post operative treatment [ Time Frame: 6 weeks ]
  • Development of acute confusional state in the postoperative period [ Time Frame: 14-17d ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2006)
  • AUC of NRS scores for first 48 hrs.
  • AUC of NRS scores for days 14-17.
  • Composite measure of pain intensity and opiate consumption
  • Number of primary oral analgesic tablets ingested between days 14-17
  • ESR and hs-CPR at three and six days and six weeks
  • IL-6 at three and six days
  • Post operative blood loss
  • WOMAC
  • Safety of post operative treatment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TRAUMEEL for Pain After Total Knee/Hip Arthroplasty
Official Title  ICMJE 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.
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Total Knee and Total Hip Arthroplasty
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: 1
    TraumeelS
    Interventions:
    • Drug: Traumeel S
    • Other: Traumeel S
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: March 27, 2006)
224
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00307853
Other Study ID Numbers  ICMJE AP 06
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Menachem Oberbaum, MD, Shaare Zedek Medical Center
Study Sponsor  ICMJE Shaare Zedek Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Menachem Oberbaum, MD Shaare Zedek Medical Center, Jerusalem, Israel
PRS Account Shaare Zedek Medical Center
Verification Date October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP