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

Pain Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00763685
• Other study ID #: 35195
• Secondary ID: EUDRACT 2008-004
• Status: Terminated
• Phase: Phase 4
• First received: September 30, 2008
• Last updated: January 29, 2012
• Start date: June 2010
• Est. completion date: November 2011

Study information

• Verified date: January 2012
• Source: East Tallinn Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Estonia: The State Agency of Medicine
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Pain
• Pain, Postoperative

Intervention

Drug:
• etoricoxib
etoricoxib 120 mg, paracetamol 1 g

Locations

Country	Name	City	State
Estonia	East Tallinn Central Hospital	Tallinn

Sponsors (2)

Lead Sponsor	Collaborator
East Tallinn Central Hospital	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scale		24 hours	No
Secondary	Vomiting		24 hours	Yes