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

East Tallinn Central Hospital

Status and phase: Terminated; Phase 4

Conditions: Pain

Treatments: Drug: etoricoxib

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00763685

35195

EUDRACT 2008-004098-17

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 3 patient groups, including a placebo group

etoricoxib 120 mg

Active Comparator group

Description:

active control

Treatment:

Drug: etoricoxib

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: etoricoxib

3

Active Comparator group

Description:

Paracetamol 1 g and etoricoxib 120 mg

Treatment:

Drug: etoricoxib