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

Double-Blind, Randomized, Placebo -Controlled 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

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.

Study Overview

• Status: Terminated
• Conditions: Pain
• Intervention / Treatment: Drug: etoricoxib

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Estonia
  • Tallinn, Estonia, 10138
    • East Tallinn Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2; Placebo	Drug: etoricoxib; etoricoxib 120 mg, paracetamol 1 g
Active Comparator: etoricoxib 120 mg; active control	Drug: etoricoxib; etoricoxib 120 mg, paracetamol 1 g
Active Comparator: 3; Paracetamol 1 g and etoricoxib 120 mg	Drug: etoricoxib; etoricoxib 120 mg, paracetamol 1 g

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain scale	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Vomiting	24 hours

Collaborators and Investigators

• Sponsor: East Tallinn Central Hospital
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Tiina Arumägi, MD, East Tallinn Central Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: September 30, 2008
• First Submitted That Met QC Criteria: September 30, 2008
• First Posted (Estimate): October 1, 2008

Study Record Updates

• Last Update Posted (Estimate): January 31, 2012
• Last Update Submitted That Met QC Criteria: January 29, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: postoperative pain; preoperative pain prophylaxis
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Etoricoxib
• Other Study ID Numbers: 35195; EUDRACT 2008-004098-17