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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pain

Intervention / Treatment
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* Drug: etoricoxib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type of gynaecologic surgery: diagnostic laparoscopy sterilization removal of ovarial cyst chromopertubation laparoscopic myomectomy laparoscopic fenestration of ovaria laparoscopic adhesiolysis Age 18-50 years. Evaluated risk of anaesthetic procedure according to ASA (American Society of Anaesthesiologist) classification: ASA I or II. Patients agreed to participate in the study and signed the informed consent. Exclusion Criteria: ASA III or more Emergency surgery Major laparoscopic surgery i.e. hysterectomy Duration of surgery more than 90 minutes Chronic pain History of hypersensitivity to the active substance or to any of the excipients of study drug (Paracetamol or Etoricoxib) Active peptic ulceration or active gastro-intestinal (GI) bleeding. 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. Pregnancy and lactation Severe hepatic dysfunction (serum albumin < 25 g/l or Child-Pugh score ≥ 10). Estimated renal creatinine clearance < 30 mL/min. Children and adolescents under 16 years of age. Inflammatory bowel disease. Congestive heart failure (NYHA II-IV). Patients with hypertension whose blood pressure has not been adequately controlled. Established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease, unstable angina. Patient has undergone coronary artery bypass graft surgery, angioplasty, or had myocardial infarction, cerebrovascular accident or transient ischemic attack within the past 6 months. History of drug abuse.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: etoricoxib 120 mg<br>active control | Drug: etoricoxib<br>* etoricoxib 120 mg, paracetamol 1 g<br>|
| Placebo Comparator: 2<br>Placebo | Drug: etoricoxib<br>* etoricoxib 120 mg, paracetamol 1 g<br>|
| Active Comparator: 3<br>Paracetamol 1 g and etoricoxib 120 mg | Drug: etoricoxib<br>* etoricoxib 120 mg, paracetamol 1 g<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scale |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vomiting |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preoperative pain prophylaxis, postoperative pain