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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

Primary Purpose

Pain

Status
Terminated
Phase
Phase 4
Locations
Estonia
Study Type
Interventional
Intervention
etoricoxib
Sponsored by
East Tallinn Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain focused on measuring preoperative pain prophylaxis, postoperative pain

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • East Tallinn Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

etoricoxib 120 mg

2

3

Arm Description

active control

Placebo

Paracetamol 1 g and etoricoxib 120 mg

Outcomes

Primary Outcome Measures

Pain scale

Secondary Outcome Measures

Vomiting

Full Information

First Posted
September 30, 2008
Last Updated
January 29, 2012
Sponsor
East Tallinn Central Hospital
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00763685
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Terminated
Why Stopped
The gynecological laparoscopic surgery transition to day surgery made following the study protocol not possible.
Study Start Date
June 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
East Tallinn Central Hospital
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
preoperative pain prophylaxis, postoperative pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
etoricoxib 120 mg
Arm Type
Active Comparator
Arm Description
active control
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
3
Arm Type
Active Comparator
Arm Description
Paracetamol 1 g and etoricoxib 120 mg
Intervention Type
Drug
Intervention Name(s)
etoricoxib
Intervention Description
etoricoxib 120 mg, paracetamol 1 g
Primary Outcome Measure Information:
Title
Pain scale
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Vomiting
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiina Arumägi, MD
Organizational Affiliation
East Tallinn Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
East Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia

12. IPD Sharing Statement

Learn more about this trial

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

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