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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-11-30

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.

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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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etoricoxib 120 mg

active control

Group Type ACTIVE_COMPARATOR

etoricoxib

Intervention Type DRUG

etoricoxib 120 mg, paracetamol 1 g

2

Placebo

Group Type PLACEBO_COMPARATOR

etoricoxib

Intervention Type DRUG

etoricoxib 120 mg, paracetamol 1 g

3

Paracetamol 1 g and etoricoxib 120 mg

Group Type ACTIVE_COMPARATOR

etoricoxib

Intervention Type DRUG

etoricoxib 120 mg, paracetamol 1 g

Interventions

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etoricoxib

etoricoxib 120 mg, paracetamol 1 g

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No