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

This study has been terminated.
(The gynecological laparoscopic surgery transition to day surgery made following the study protocol not possible.)
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Tiina Arumagi, East Tallinn Central Hospital
ClinicalTrials.gov Identifier:
NCT00763685
First received: September 30, 2008
Last updated: January 29, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Pain
Drug: etoricoxib
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by East Tallinn Central Hospital:

Primary Outcome Measures:
  • Pain scale [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vomiting [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: June 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: etoricoxib 120 mg
active control
Drug: etoricoxib
etoricoxib 120 mg, paracetamol 1 g
Placebo Comparator: 2
Placebo
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00763685

Locations
Estonia
East Tallinn Central Hospital
Tallinn, Estonia, 10138
Sponsors and Collaborators
East Tallinn Central Hospital
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Tiina Arumägi, MD East Tallinn Central Hospital
  More Information

No publications provided

Responsible Party: Tiina Arumagi, anaesthesiologist, East Tallinn Central Hospital
ClinicalTrials.gov Identifier: NCT00763685     History of Changes
Other Study ID Numbers: 35195, EUDRACT 2008-004098-17
Study First Received: September 30, 2008
Last Updated: January 29, 2012
Health Authority: Estonia: The State Agency of Medicine

Keywords provided by East Tallinn Central Hospital:
preoperative pain prophylaxis
postoperative pain

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Acetaminophen
Etoricoxib
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014