Study to Evaluate the Efficacy of Pre-operative Administration of Etoricoxib 120 mg, Etoricoxib 120 mg and Paracetamol 1 g Combination or Placebo in the Treatment of Postoperative Pain in Patients Undergoing Gynaecologic Laparoscopic Surgery

• Status: Terminated
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

Primary Hypothesis:

1. The analgesic effect of etoricoxib 120 mg administered 1 hour preoperatively is greater than that of placebo in the treatment of postoperative pain.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: East Tallinn Central Hospital
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Acetaminophen; Etoricoxib

Criteria

Inclusion Criteria:

1. Type of gynaecologic surgery:

• diagnostic laparoscopy

• sterilization

• removal of ovarial cyst

• chromopertubation

• laparoscopic myomectomy

• laparoscopic fenestration of ovaria

• laparoscopic adhesiolysis

2. Age 18-50 years.

3. Evaluated risk of anaesthetic procedure according to ASA (American Society of Anaesthesiologist) classification: ASA I or II.

4. Patients agreed to participate in the study and signed the informed consent.

Exclusion Criteria:

1. ASA III or more

2. Emergency surgery

3. Major laparoscopic surgery i.e. hysterectomy

4. Duration of surgery more than 90 minutes

5. Chronic pain

6. History of hypersensitivity to the active substance or to any of the excipients of study drug (Paracetamol or Etoricoxib)

7. Active peptic ulceration or active gastro-intestinal (GI) bleeding.

8. Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors.

9. Pregnancy and lactation

10. Severe hepatic dysfunction (serum albumin < 25 g/l or Child-Pugh score ≥ 10).

11. Estimated renal creatinine clearance < 30 mL/min.

12. Children and adolescents under 16 years of age.

13. Inflammatory bowel disease.

14. Congestive heart failure (NYHA II-IV).

15. Patients with hypertension whose blood pressure has not been adequately controlled.

16. Established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease, unstable angina.

17. Patient has undergone coronary artery bypass graft surgery, angioplasty, or had myocardial infarction, cerebrovascular accident or transient ischemic attack within the past 6 months.

18. History of drug abuse.