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

NCT00763685 | Terminated Phase 4

• 2 other identifiers: 35195EUDRACT 2008-004098-17
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain

Keywords

preoperative pain prophylaxis; postoperative pain

Outcome Measures

Primary Outcomes (1)

• Pain scale

  24 hours

Secondary Outcomes (1)

• Vomiting

  24 hours

Study Arms (3)

etoricoxib 120 mg

ACTIVE COMPARATOR

active control

Drug: etoricoxib

2

PLACEBO COMPARATOR

Placebo

Drug: etoricoxib

3

ACTIVE COMPARATOR

Paracetamol 1 g and etoricoxib 120 mg

Drug: etoricoxib

Interventions

etoricoxib DRUG

etoricoxib 120 mg, paracetamol 1 g

2; 3; etoricoxib 120 mg

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• East Tallinn Central Hospital: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

East Tallinn Central Hospital

Tallinn, 10138, Estonia

Location

MeSH Terms

Conditions

Pain; Pain, Postoperative

Interventions

Etoricoxib

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Tiina Arumägi, MD

  East Tallinn Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: anaesthesiologist

Study Record Dates

• First Submitted: September 30, 2008
• First Posted: October 1, 2008
• Study Start: June 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: January 31, 2012

Record last verified: 2012-01

Locations

ES (1)