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

Phase 4

Terminated

• Conditions: Pain
• Interventions: Drug: etoricoxib

• Registration Number: NCT00763685
• Lead Sponsor: East Tallinn Central Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-30
• Study First Submitted QC: 2008-09-30
• Study First Posted: 2008-10-01
• Study Start: 2010-06
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-29
• Last Update Posted: 2012-01-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 40

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
etoricoxib 120 mg	etoricoxib	active control
2	etoricoxib	Placebo
3	etoricoxib	Paracetamol 1 g and etoricoxib 120 mg

Primary Outcome Measures

Name	Time	Method
Pain scale	24 hours

Secondary Outcome Measures

Name	Time	Method
Vomiting	24 hours

Trial Locations

Locations (1)

East Tallinn Central Hospital; 🇪🇪 Tallinn, Estonia