TRAUMEEL for Pain After Total Knee/Hip Arthroplasty

NCT00307853 | Terminated Phase 3

• 1 other identifier: AP 06
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 2

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.

Conditions

Total Knee and Total Hip Arthroplasty

Keywords

homeopathy; pain; traumeel s; total knee arthroplasty; total hip arthroplasty

Outcome Measures

Primary Outcomes (1)

• Cumulative 48-hour postoperative morphine consumption as consumed by the patient via the PCA device

  48h

Secondary Outcomes (9)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

TraumeelS

Drug: Traumeel S; Other: Traumeel S

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Traumeel S DRUG

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.

1

Placebo OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of either sex undergoing unilateral THAP or TKAP.
• Age over 18 years.
• Signature upon informed consent form

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (2)

Dept. of Orthopedic Surgery, Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

Department of Orthopedics, Meir Medical Center

Kfar Saba, Israel

Location

MeSH Terms

Conditions

Pain

Interventions

Traumeel S

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Menachem Oberbaum, MD

  Shaare Zedek Medical Center, Jerusalem, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 27, 2006
• First Posted: March 28, 2006
• Study Start: August 1, 2008
• Primary Completion: August 1, 2009
• Last Updated: October 20, 2009

Record last verified: 2009-10

Locations

IL (2)