Lornoxicam vs. Paracetamol After Lower Abdominal Surgery

NCT ID: NCT01564680

Last Updated: 2012-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lornoxicam

Lornoxicam 16 mg will be given at skin closure and 8 mg will be given 12 hours postoperatively

Group Type EXPERIMENTAL

Lornoxicam

Intervention Type DRUG

16 mg at skin closure and 8 mg 12 hours postoperative

Control

Patients will receive normal saline at skin closure, at 6, 12, 18 hours postoperatively.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

normal saline

Paracetamol

1 gm of paracetamol will be given at skin closure, 6, 12, 18 hours postoperatively

Group Type EXPERIMENTAL

Paracetamol

Intervention Type DRUG

IV paracetamol infusion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

placebo

normal saline

Intervention Type OTHER

Paracetamol

IV paracetamol infusion

Intervention Type DRUG

Lornoxicam

16 mg at skin closure and 8 mg 12 hours postoperative

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

0.9 N sodium chloride perfalgan xefo

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Imam Abdulrahman Bin Faisal University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hany A Mowafi, MD

Role: PRINCIPAL_INVESTIGATOR

UD

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dammam University, KFHU

Khobar, EP, Saudi Arabia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Saudi Arabia

References

Explore related publications, articles, or registry entries linked to this study.

Mowafi HA, Elmakarim EA, Ismail S, Al-Mahdy M, El-Saflan AE, Elsaid AS. Intravenous lornoxicam is more effective than paracetamol as a supplemental analgesic after lower abdominal surgery: a randomized controlled trial. World J Surg. 2012 Sep;36(9):2039-44. doi: 10.1007/s00268-012-1649-2.

Reference Type DERIVED
PMID: 22584689 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

#201021

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pain Management After Surgery
NCT05154682 UNKNOWN PHASE3