TRAUMEEL for Pain After Fracture of Neck of Femur - Full Text View

Purpose

We hypothesize that Traumeel S is more effective than placebo in reducing 48-hour mean cumulative morphine consumption in patients scheduled for surgical correction of fracture of neck of hip.

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.

Condition	Intervention	Phase
Pain Fracture of Neck of Femur	Drug: Traumeel S Drug: Placebo remedy	Phase III

MedlinePlus related topics:

Fractures

ChemIDplus related topics:

Traumeel S

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel 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 Post-Operative Pain After Fracture of Neck of Femur

Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:

Cumulative 48-hour postoperative morphine consumption [ Time Frame: 48h ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Secondary: AUC of NRS scores for first 48 hrs.; [ Time Frame: 48h ] [ Designated as safety issue: Yes ]
AUC of NRS scores for days 14-17.; [ Time Frame: 17d ] [ Designated as safety issue: Yes ]
Composite measure of pain intensity and opiate consumption; [ Time Frame: 17d ] [ Designated as safety issue: Yes ]
Number of primary oral analgesic tablets ingested between days 14-17; [ Time Frame: 17d ] [ Designated as safety issue: Yes ]
ESR and hs-CPR at three and six days and six weeks; [ Time Frame: 42d ] [ Designated as safety issue: No ]
IL-6 at three and six days; [ Time Frame: 6d ] [ Designated as safety issue: No ]
Post operative blood loss; [ Time Frame: 48h ] [ Designated as safety issue: Yes ]
WOMAC; [ Time Frame: 17d ] [ Designated as safety issue: Yes ]
Safety of post operative treatment [ Time Frame: 17d ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	224
Study Start Date:	January 2009
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator TRAUMEEL S	Drug: Traumeel S homeopathic remedy
B: Placebo Comparator placebo remedy	Drug: Placebo remedy identical size, shape and taste of treatment medication

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 surgical correction of unilateral fracture of neck of hip.
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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00307905

Contacts


Contact: Menachem Oberbaum, MD	972-2-6666395	oberbaum@szmc.org.il

Locations


Israel
	Dept. of Orthopedic Surgery, Shaare Zedek Medical Center	Not yet recruiting
	Jerusalem, Israel
	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:	NoF 06 CTIL
First Received:	March 27, 2006
Last Updated:	October 6, 2008
ClinicalTrials.gov Identifier:	NCT00307905
Health Authority:	Israel: Ministry of Health

Keywords provided by Shaare Zedek Medical Center:

homeopathy

pain

traumeel s

Fracture of neck of femur

Surgical correction of fracture of neck of hip

Study placed in the following topic categories:

Femoral Neck Fractures

Hip Fractures

Femoral Fractures

Fractures, Bone

Wounds and Injuries

Disorders of Environmental Origin

Leg Injuries

Pain

Pain, Postoperative

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Shaare Zedek Medical Center
Information provided by:	Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:	NCT00307905