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This study has been withdrawn prior to enrollment.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:
Shaare Zedek Medical Center
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
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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
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:
|
Femoral Neck Fractures Fractures, Bone Hip Fractures |
Femoral Fractures Wounds and Injuries Leg Injuries |
ClinicalTrials.gov processed this record on May 21, 2013