TRAUMEEL for Pain After Fracture of Neck of Femur

October 28, 2010 updated by: Shaare Zedek Medical Center

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

224

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Dept. of Orthopedic Surgery, Shaare Zedek Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cumulative 48-hour postoperative morphine consumption
Time Frame: 48h
48h

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary: AUC of NRS scores for first 48 hrs.;
Time Frame: 48h
48h
AUC of NRS scores for days 14-17.;
Time Frame: 17d
17d
Composite measure of pain intensity and opiate consumption;
Time Frame: 17d
17d
Number of primary oral analgesic tablets ingested between days 14-17;
Time Frame: 17d
17d
ESR and hs-CPR at three and six days and six weeks;
Time Frame: 42d
42d
IL-6 at three and six days;
Time Frame: 6d
6d
Post operative blood loss;
Time Frame: 48h
48h
WOMAC;
Time Frame: 17d
17d
Safety of post operative treatment
Time Frame: 17d
17d

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaare Zedek Medical Center

Investigators

  • Principal Investigator: Menachem Oberbaum, MD, Shaare Zedek Medical Center, Jerusalem, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

March 27, 2006

First Submitted That Met QC Criteria

March 27, 2006

First Posted (Estimate)

March 28, 2006

Study Record Updates

Last Update Posted (Estimate)

October 29, 2010

Last Update Submitted That Met QC Criteria

October 28, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NoF 06 CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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