Pain Post Abdominal Laparoscopy Prevention With Arcoxia

Hospital Vozandez

Status and phase: Completed; Phase 4

Conditions: Laparoscopic Surgery for Cholecystitis; Laparoscopic Surgery for Ovarian Cysts; Laparoscopic Surgery for Appendicitis

Treatments: Drug: etoricoxib 120 mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00565682

DOLAAR

Details and patient eligibility

About

To test the analgesic efficacy of etoricoxib used before a surgical procedure compared to the already known effect when administered after such a procedure. Patient will be receiving either etoricoxib or the respective placebo one hour before surgery, then two hours after those receiving the active will receive placebo and those that received placebo will be given etoricoxib. Pain score measurements will be performed sequentially. Rescue medication will be available all the time.

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Voluntary acceptance to participate in the study and signed the informed consent form
• Age older than 18 years old and younger than 70 years
• Diagnosis of appendicitis, cholecystitis or ovarian cysts suitable of laparoscopic surgery

Exclusion criteria

• Age less than 18 years or older than 70 years.
• Laparoscopic procedures for diagnostic purposes.
• Current use of anticoagulants.
• Known hypersensitivity to etoricoxib or its components.
• History of a CABG or MI (less than 1 year)
• History of unstable angina (over the past six months).
• Current inflammatory bowel disease.
• Uncontrolled hypertension or heart failure
• Renal dysfunction/impairment (creatinine clearance < 30ml/min)
• Cirrhosis or severe hepatic dysfunction
• Any degree of dehydration (mild to severe)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 1 patient group

A

Experimental group

Description:

Etoricoxib 120 mg

Treatment:

Drug: etoricoxib 120 mg