TRAUMEEL for Pain After Fracture of Neck of Femur

This study has been withdrawn prior to enrollment.
(Anticipation of inadequate recruitment according to current format.)
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00307905
First received: March 27, 2006
Last updated: October 28, 2010
Last verified: October 2010
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel 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 Post-operative Pain After Fracture of Neck of Femur

Resource links provided by NLM:


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 2011
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
TRAUMEEL S
Drug: Traumeel S
homeopathic remedy
Placebo Comparator: B
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
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: NCT00307905

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: Menachem Oberbaum, MD, Shaare Zedek Medical Center,
ClinicalTrials.gov Identifier: NCT00307905     History of Changes
Other Study ID Numbers: NoF 06 CTIL
Study First Received: March 27, 2006
Last Updated: October 28, 2010
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

Additional relevant MeSH terms:
Fractures, Bone
Femoral Neck Fractures
Wounds and Injuries
Hip Fractures
Femoral Fractures
Leg Injuries

ClinicalTrials.gov processed this record on September 22, 2014