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

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

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

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

Resource links provided by NLM:

MedlinePlus related topics: Fractures Surgery

Drug Information available for: Traumeel S

U.S. FDA Resources

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:	April 2010
Estimated Primary Completion Date:	June 2011 (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
Jerusalem, 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:	Shaare Zedek Medical Center, ( Menachem Oberbaum, MD )
Study ID Numbers:	NoF 06 CTIL
Study First Received:	March 27, 2006
Last Updated:	April 19, 2009
ClinicalTrials.gov Identifier:	NCT00307905 History of Changes
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

Additional relevant MeSH terms:

Femoral Neck Fractures
Hip Fractures
Femoral Fractures
Fractures, Bone

Wounds and Injuries
Disorders of Environmental Origin
Leg Injuries

ClinicalTrials.gov processed this record on July 06, 2009