Lornoxicam vs. Paracetamol After Lower Abdominal Surgery

Phase 4

Completed

• Conditions: Postoperative Pain
• Interventions: Other: placebo; Drug: Lornoxicam; Drug: Paracetamol

• Registration Number: NCT01564680
• Lead Sponsor: Imam Abdulrahman Bin Faisal University

Brief Summary

Background: The aim of this prospective, randomized, double-blind study is to determine the most effective supplemental analgesic, paracetamol or lornoxicam for postoperative pain relief after lower abdominal surgery.

Methods: Sixty patients scheduled for lower abdominal surgery under general anesthesia were randomly allocated to receive either isotonic saline (Control group), intravenous paracetamol 1 g every 6 h (Paracetamol group) or lornoxicam 16 mg then 8 mg after 12 h (Lornoxicam group). Additionally pain was treated postoperatively using morphine patient-controlled analgesia. Postoperative pain scores measured by the verbal pain score (VPS), morphine consumption and the incidence of side effects were measured at 1, 2, 4, 8, 12 and 24 hours postoperatively.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2012-03
• Study First Submitted: 2012-03-26
• Study First Submitted QC: 2012-03-27
• Last Update Submitted: 2012-03-27
• Study First Posted: 2012-03-28
• Last Update Posted: 2012-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• lower abdominal surgery

Exclusion Criteria

• body weight more than 150% of their ideal body weight
• history of significant cardiac, pulmonary, renal, hepatic or hematological disease; chronic drug or alcohol abuse; hypersensitivity to any of the studied drugs; bronchial asthma; gastritis or peptic ulcer; and pregnancy
• patients who received any analgesic drug a day before surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	placebo	Patients will receive normal saline at skin closure, at 6, 12, 18 hours postoperatively.
Lornoxicam	Lornoxicam	Lornoxicam 16 mg will be given at skin closure and 8 mg will be given 12 hours postoperatively
Paracetamol	Paracetamol	1 gm of paracetamol will be given at skin closure, 6, 12, 18 hours postoperatively

Primary Outcome Measures

Name	Time	Method
Postoperative pain	24 hours	Postoperative pain scores measured by the verbal pain score (VPS)1, 2, 4, 8, 12 and 24 hours postoperatively.

Secondary Outcome Measures

Name	Time	Method
Morphine consumption	24 hours	pain was treated postoperatively using morphine patient-controlled analgesia. Morphine consumption was measured at 1, 2, 4, 8, 12 and 24 hours postoperatively
Incidence of side-effects	24 hours	incidence of side effects was measured at 1,2,4,8, 12, 24 hr postoperatively.

Trial Locations

Locations (1)

Dammam University, KFHU; 🇸🇦 Al-Khobar, EP, Saudi Arabia