TRAUMEEL for Pain After Total Knee/Hip Arthroplasty

Total Knee and Total Hip Arthroplasty Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00307853
• Other study ID #: AP 06
• Status: Terminated
• Phase: Phase 3
• First received: March 27, 2006
• Last updated: October 18, 2009
• Start date: August 2008

Study information

• Verified date: October 2009
• Source: Shaare Zedek Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 224
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Total Knee and Total Hip Arthroplasty

Intervention

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
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.

Locations

Country	Name	City	State
Israel	Dept. of Orthopedic Surgery, Shaare Zedek Medical Center	Jerusalem
Israel	Department of Orthopedics, Meir Medical Center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative 48-hour postoperative morphine consumption as consumed by the patient via the PCA device		48h	No
Secondary	AUC of NRS scores for days 14-17.		14-17d	No
Secondary	Cumulative 24-hour postoperative morphine consumption as consumed by the patient via the PCA device		24h	No
Secondary	Number of primary oral analgesic tablets ingested between days 14-17		14-17d	No
Secondary	ESR and hs-CPR at three and six days and six weeks		6d and 3weeks	No
Secondary	IL-6 at three and six days		3 and 6d	No
Secondary	Post operative blood loss		postoperative period	No
Secondary	WOMAC		6 weeks	No
Secondary	Safety of post operative treatment		6 weeks	Yes
Secondary	Development of acute confusional state in the postoperative period		14-17d	No