Trial | NCT00763685  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Terminated

  • Indication/Condition

    Pain

  • Intervention/Treatment

    etoricoxib ...

  • Study Participants

    40
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 Started
Jun 30
2010
Primary Completion
Nov 30
2011
Study Completion
Nov 30
2011
Last Update
Jan 31
2012
Estimate

Drug etoricoxib

etoricoxib 120 mg, paracetamol 1 g

etoricoxib 120 mg Active Comparator

active control

2 Placebo Comparator

Placebo

3 Active Comparator

Paracetamol 1 g and etoricoxib 120 mg

Criteria 

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.
No Results Posted