TRAUMEEL for Pain After Total Knee/Hip Arthroplasty

Phase 3

Terminated

• Conditions: Total Knee and Total Hip Arthroplasty
• Interventions: Other: Placebo; Other: Traumeel S

• Registration Number: NCT00307853
• Lead Sponsor: Shaare Zedek Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-03-27
• Study First Submitted QC: 2006-03-27
• Study First Posted: 2006-03-28
• Study Start: 2008-08
• Primary Completion: 2009-08
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-18
• Last Update Posted: 2009-10-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 224

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
1	Traumeel S	TraumeelS

Primary Outcome Measures

Name	Time	Method
Cumulative 48-hour postoperative morphine consumption as consumed by the patient via the PCA device	48h

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Dept. of Orthopedic Surgery, Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel

Department of Orthopedics, Meir Medical Center; 🇮🇱 Kfar Saba, Israel