Traumeel S for Reduction of Post Operative Pain Following Arthroscopy

Shaare Zedek Medical Center

Status and phase

Suspended

Phase 3

Conditions

Post-operative Pain

Treatments

Drug: Traumeel S: intra-operative irrigation + oral ingestion

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00307892

Arth 06 CTIL

Details and patient eligibility

About

The perception of pain is a complex process that is not yet fully understood. With outpatient knee arthroscopy becoming standard of care, postoperative pain management has become increasingly important in caring for patients. Traumeel S is a homeopathic complex widely used in German-speaking Europe for orthopedic pain and inflammation. It contains a mixture of medicinal plants and minerals, all highly diluted. In some recent studies, Traumeel has shown anti-inflammatory and analgesic activity.

In this study, the efficacy of Traumeel S will be compared with placebo in reducing pain during the first 48 hours after arthroscopy. Also compared will be 6 day pain levels, analgesic consumption, quality of life, post operative knee function, quadriceps atrophy and safety.

The study design is double blind RCT. 98 patients, aged 18-40 and undergoing arthroscopic meniscectomy or chondroplasty will be enrolled in the trial. Patients will be randomized to receive either intraoperative join irrigation with Traumeel S and oral treatment with Traumeel S, or placebo irrigation and oral ingestion. Patients will continue to take active or placebo medication for 6 days. Pain will be recorded daily by the patient in the patient diary using an 11-point numerical rating score (NRS-11. Patients will also record daily consumption of primary and "rescue" analgesics. Range of motion (RoM) will be measured on days 6 and 30 post-operatively, and the Lysholm knee scale and circumference of thigh above patella will be measured at 30 days. All these measures will be compared with baseline. Patients will be contacted daily by the research assistant to encourage compliance and to record their daily NRS and analgesic consumption in the CRF.

Enrollment

98 estimated patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients of either sex undergoing unilateral arthroscopy for menisectomy or chondroplasty, w/o ligament reconstruction .
Age 18 - 40 years.
Meeting none of exclusion criteria.

Exclusion criteria

Participation in another clinical trial within 4 weeks prior to enrollment.
Inability to comply with the study protocol.
Impossibility to be reached during the whole follow-up period (7 days post operative)
Refused to give oral consent to the telephone interviews
Previous arthroscopy on ipsilateral knee.
Current use of analgesia for any other reason except for the knee complaint.
Any disease considered to inhibit wound healing (e.g. Diabetes mellitus, Berger, any PVD, DVT).
Known sensitivity to dipyrone or diclofenac