Lornoxicam vs. Paracetamol After Lower Abdominal Surgery

March 27, 2012 updated by: Imam Abdulrahman Bin Faisal University

Intravenous Lornoxicam is More Effective Than Paracetamol as a Supplemental Analgesic After Lower Abdominal Surgery; A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
    • EP
      • Al-Khobar, EP, Saudi Arabia, 31952
        • Dammam University, KFHU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lornoxicam
Lornoxicam 16 mg will be given at skin closure and 8 mg will be given 12 hours postoperatively
Drug: Lornoxicam
16 mg at skin closure and 8 mg 12 hours postoperative
Other Names:
  • xefo
PLACEBO_COMPARATOR: Control
Patients will receive normal saline at skin closure, at 6, 12, 18 hours postoperatively.
Other: placebo
normal saline
Other Names:
  • 0.9 N sodium chloride
EXPERIMENTAL: Paracetamol
1 gm of paracetamol will be given at skin closure, 6, 12, 18 hours postoperatively
Drug: Paracetamol
IV paracetamol infusion
Other Names:
  • perfalgan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain
Time Frame: 24 hours
Postoperative pain scores measured by the verbal pain score (VPS)1, 2, 4, 8, 12 and 24 hours postoperatively.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphine consumption
Time Frame: 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
24 hours
Incidence of side-effects
Time Frame: 24 hours
incidence of side effects was measured at 1,2,4,8, 12, 24 hr postoperatively.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imam Abdulrahman Bin Faisal University

Investigators

  • Principal Investigator: Hany A Mowafi, MD, UD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (ACTUAL)

March 1, 2011

Study Completion (ACTUAL)

March 1, 2011

Study Registration Dates

First Submitted

March 26, 2012

First Submitted That Met QC Criteria

March 27, 2012

First Posted (ESTIMATE)

March 28, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 28, 2012

Last Update Submitted That Met QC Criteria

March 27, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #201021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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