TRAUMEEL for Pain After Total Knee/Hip Arthroplasty - Full Text View

Sponsored by:	Shaare Zedek Medical Center
Information provided by:	Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:	NCT00307853

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 III

Drug Information available for: Traumeel S

U.S. FDA Resources

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.

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:	February 2008
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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: 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.

Arms

Assigned Interventions

1: Active Comparator

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: 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.

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

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

Contacts

Contact: Menachem Oberbaum, MD

972-2-6666395

oberbaum@szmc.org.il

Locations

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

Sponsors and Collaborators

Shaare Zedek Medical Center

Investigators

Principal Investigator:

Menachem Oberbaum, MD

Shaare Zedek Medical Center, Jerusalem, Israel

More Information

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

Keywords provided by Shaare Zedek Medical Center:

homeopathy
pain
traumeel s
total knee arthroplasty
total hip arthroplasty

Study placed in the following topic categories:

Pain

ClinicalTrials.gov processed this record on January 14, 2009