TRAUMEEL for Pain After Total Knee/Hip Arthroplasty

A Randomised, Double - Blind, Placebo Controlled Clinical Trial to Assess the Efficacy of the Homeopathic Medication TRAUMEEL S in Controlling Pain After Total Knee and Total Hip Arthroplasty.

We hypothesize that Traumeel S is more effective than placebo in reducing 48-hour mean cumulative morphine consumption following Total Knee or Hip Arthroplasty.

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.

In the recovery room, the patient will begin to receive IV Dipyrone (Optalgin) 1000mg, for a total of 4 doses during the first 24 hours postoperatively (1000 mg every 6 hours). Once back in the ward, the patient will be connected to an IV Patient-Controlled Analgesia (PCA) device, enabling the self-administration of morphine at a set dose of 1mg every 8 minutes, should the patient require it. The PCA memory registers the time and dose, and the data will be used later to evaluate post-operative pain.

Study Overview

• Status: Terminated
• Conditions: Total Knee and Total Hip Arthroplasty
• Intervention / Treatment: Drug: Traumeel S; Other: Traumeel S; Other: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 224
• Phase: Phase 3

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 91031
    • Dept. of Orthopedic Surgery, Shaare Zedek Medical Center
  • Kfar Saba, Israel
    • Department of Orthopedics, Meir Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients of either sex undergoing unilateral THAP or TKAP.
• 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 leg.
• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; All patients will receive an intra-operative injection of either Traumeel S or placebo solution. Afterwards, verum or indistinguishable placebo tablets, PO, two tablets five times daily from day 0 to 6 post-operatively, and two tablets three times daily from day 7 until day 21. To the extent possible, administration of tablets should be equally spaced between morning and evening (e.g. every 6 hours) at the same time every day.
Active Comparator: 1; TraumeelS	Drug: Traumeel S; All patients will receive an intra-operative injection of either Traumeel S or placebo solution. Afterwards, verum or indistinguishable placebo tablets, PO, two tablets five times daily from day 0 to 6 post-operatively, and two tablets three times daily from day 7 until day 21. To the extent possible, administration of tablets should be equally spaced between morning and evening (e.g. every 6 hours) at the same time every day.; Other: Traumeel S; All patients will receive an intra-operative injection of either Traumeel S or placebo solution. Afterwards, verum or indistinguishable placebo tablets, PO, two tablets five times daily from day 0 to 6 post-operatively, and two tablets three times daily from day 7 until day 21. To the extent possible, administration of tablets should be equally spaced between morning and evening (e.g. every 6 hours) at the same time every day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cumulative 48-hour postoperative morphine consumption as consumed by the patient via the PCA device	48h

Secondary Outcome Measures

Outcome Measure	Time Frame
AUC of NRS scores for days 14-17.	14-17d
Cumulative 24-hour postoperative morphine consumption as consumed by the patient via the PCA device	24h
Number of primary oral analgesic tablets ingested between days 14-17	14-17d
ESR and hs-CPR at three and six days and six weeks	6d and 3weeks
IL-6 at three and six days	3 and 6d
Post operative blood loss	postoperative period
WOMAC	6 weeks
Safety of post operative treatment	6 weeks
Development of acute confusional state in the postoperative period	14-17d

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Anticipated): August 1, 2009

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 20, 2009
• Last Update Submitted That Met QC Criteria: October 18, 2009
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Keywords: pain; total hip arthroplasty; total knee arthroplasty; homeopathy; traumeel s
• Other Study ID Numbers: AP 06