Clinical trial NCT00307853: TRAUMEEL for Pain After Total Knee/Hip Arthroplasty
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Total Knee and Total Hip Arthroplasty
Keywords: homeopathy
pain
traumeel s
total knee arthroplasty
total hip arthroplasty
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2006-03-28
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cumulative 48-hour postoperative morphine consumption as consumed by the patient via the PCA device
timeFrame: 48h
Secondary outcomes:
measure: AUC of NRS scores for days 14-17.
timeFrame: 14-17d
measure: Cumulative 24-hour postoperative morphine consumption as consumed by the patient via the PCA device
timeFrame: 24h
measure: Number of primary oral analgesic tablets ingested between days 14-17
timeFrame: 14-17d
measure: ESR and hs-CPR at three and six days and six weeks
timeFrame: 6d and 3weeks
measure: IL-6 at three and six days
timeFrame: 3 and 6d
measure: Post operative blood loss
timeFrame: postoperative period
measure: WOMAC
timeFrame: 6 weeks
measure: Safety of post operative treatment
timeFrame: 6 weeks
measure: Development of acute confusional state in the postoperative period
timeFrame: 14-17d
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Dept. of Orthopedic Surgery, Shaare Zedek Medical Center
city: Kfar Saba
country: Israel
facility: Department of Orthopedics, Meir Medical Center
Study officials:
affiliation: Shaare Zedek Medical Center, Jerusalem, Israel
name: Menachem Oberbaum, MD
role: PRINCIPAL_INVESTIGATOR
References: