TRAUMEEL for Pain After Total Knee/Hip Arthroplasty

• Sponsor: Shaare Zedek Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00307853
• Collaborator: (none)
• Enrollment: 224
• Locations: 2
• Arms: 2
• Patients Per Site: 112

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Total Knee and Total Hip Arthroplasty	Drug: Traumeel S; Other: Traumeel S; Other: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 224 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Quadruple (Participant, Care Provider, 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 Pain After Total Knee and Total Hip Arthroplasty.
• Study Start Date: Aug 1, 2008
• Anticipated Primary Completion Date: Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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.
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.

Outcome Measures

Primary Outcome Measures

1. Cumulative 48-hour postoperative morphine consumption as consumed by the patient via the PCA device [48h]

Secondary Outcome Measures

1. AUC of NRS scores for days 14-17. [14-17d]

2. Cumulative 24-hour postoperative morphine consumption as consumed by the patient via the PCA device [24h]

3. Number of primary oral analgesic tablets ingested between days 14-17 [14-17d]

4. ESR and hs-CPR at three and six days and six weeks [6d and 3weeks]

5. IL-6 at three and six days [3 and 6d]

6. Post operative blood loss [postoperative period]

7. WOMAC [6 weeks]

8. Safety of post operative treatment [6 weeks]

9. Development of acute confusional state in the postoperative period [14-17d]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept. of Orthopedic Surgery, Shaare Zedek Medical Center	Jerusalem		Israel	91031
2	Department of Orthopedics, Meir Medical Center	Kfar Saba		Israel

Sponsors and Collaborators

• Shaare Zedek Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00307853
• Other Study ID Numbers: AP 06
• First Posted: Mar 28, 2006
• Last Update Posted: Oct 20, 2009
• Last Verified: Oct 1, 2009

• Keywords provided by , ,: homeopathy; pain; traumeel s; total knee arthroplasty; total hip arthroplasty

Study Results

No Results Posted as of Oct 20, 2009