TRAUMEEL for Pain After Total Knee/Hip Arthroplasty

Shaare Zedek Medical Center

Status and phase: Terminated; Phase 3

Conditions: Total Knee and Total Hip Arthroplasty

Treatments: Other: Traumeel S; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00307853

AP 06

Details and patient eligibility

About

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.

Enrollment: 224 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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224 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

TraumeelS

Treatment:

Other: Traumeel S

Other: Traumeel S

Placebo

Placebo Comparator group

Treatment:

Other: Placebo