TRAUMEEL for Pain After Total Knee/Hip Arthroplasty

This study has been terminated.
(lack of patients)
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00307853
First received: March 27, 2006
Last updated: October 18, 2009
Last verified: October 2009
  Purpose

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
Total Knee and Total Hip Arthroplasty
Drug: Traumeel S
Other: Traumeel S
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • Cumulative 48-hour postoperative morphine consumption as consumed by the patient via the PCA device [ Time Frame: 48h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUC of NRS scores for days 14-17. [ Time Frame: 14-17d ] [ Designated as safety issue: No ]
  • Cumulative 24-hour postoperative morphine consumption as consumed by the patient via the PCA device [ Time Frame: 24h ] [ Designated as safety issue: No ]
  • Number of primary oral analgesic tablets ingested between days 14-17 [ Time Frame: 14-17d ] [ Designated as safety issue: No ]
  • ESR and hs-CPR at three and six days and six weeks [ Time Frame: 6d and 3weeks ] [ Designated as safety issue: No ]
  • IL-6 at three and six days [ Time Frame: 3 and 6d ] [ Designated as safety issue: No ]
  • Post operative blood loss [ Time Frame: postoperative period ] [ Designated as safety issue: No ]
  • WOMAC [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Safety of post operative treatment [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Development of acute confusional state in the postoperative period [ Time Frame: 14-17d ] [ Designated as safety issue: No ]

Estimated Enrollment: 224
Study Start Date: August 2008
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
TraumeelS
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.
Placebo Comparator: Placebo 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00307853

Locations
Israel
Dept. of Orthopedic Surgery, Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Department of Orthopedics, Meir Medical Center
Kfar Saba, Israel
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Menachem Oberbaum, MD Shaare Zedek Medical Center, Jerusalem, Israel
  More Information

No publications provided

Responsible Party: Menachem Oberbaum, MD, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT00307853     History of Changes
Other Study ID Numbers: AP 06
Study First Received: March 27, 2006
Last Updated: October 18, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by Shaare Zedek Medical Center:
homeopathy
pain
traumeel s
total knee arthroplasty
total hip arthroplasty

ClinicalTrials.gov processed this record on July 29, 2014