Comparison of Lornoxicam and Paracetamol for Pre-emptive Intravenous Analgesia for Elective Inguinal Hernia Repair

NCT ID: NCT01069055

Last Updated: 2010-02-24

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-06-30

Brief Summary

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

The purpose of this study is to determine whether lornoxicam or paracetamol is more effective in providing pre-emptive analgesia for adult patients undergoing elective unilateral inguinal hernia repair under general anesthesia.

Detailed Description

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

Early postoperative pain is the major cause that may restric physical activity of the patients and delay in returning work. Newer non-steroid analgesic drugs (NSAD) can be helpful in overcoming this problem, especially in pre-emptive use. In this prospective randomized placebo controlled double blinded study we aimed to determine whether lornoxicam, as a NSAD, or paracetamol is more effective in providing pre-emptive analgesia for patients undergo elective unilateral inguinal hernai repair under general anesthesia. 60 patients above the age of 18, ASA score of I to III will be assigned into 3 groups. All the patients will be operated under general anesthesia. Recurrent hernia cases, pregnant or lactated women, patients allergic to the two drugs, patients with documented gastric disorders or bleeding disorder or under anticoagulent therapy will be excluded.

Group designs:

Group I: 100 ml intravenous saline infusion as placebo 30 minitues before the surgery.

Group II: 8 mg intravenous lornoxicam infusion in 100 ml saline 30 minitues before the surgery.

Group III: 1 g intravenous paracetamol infusion in 100 ml saline 30 minitues before the surgery.

All patients will receive patient controlled intravenous analgesia with morphine for 24 hours postoperatively.

Postoperative pain levels will be determined by VAS (visual analog scale) and morphine consumption will be recorded.

Patients will be prescribed with oral paracetamol (300 mg) plus codein (15 mg)at discharge at the end first 24 hours.

Patients will be asked to record daily consumption of given analgesic, pain response to physical activity by using Likert scale, and VAS scores daily.

The first follow-up examination will take place on day-7. The patients will be asked to keep recording the same parameters until the second hospital visit at 4th week.

On the follow-up examination at 4th week quality of life will be determined by SF-36 form.

The results will be analyzed using SPSS for Windows software.

Conditions

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

Inguinal Hernia 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

PREVENTION

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.

Placebo Control

Group I (Placebo Control) 100 ml intravenous saline infusion as placebo 30 minitues before the surgery.

Group Type PLACEBO_COMPARATOR

Sterile Saline

Intervention Type OTHER

Group I: 100 ml intravenous saline infusion as placebo 30 minitues before the surgery.

Lornoxicam

Group II: 8 mg intravenous lornoxicam infusion in 100 ml saline 30 minitues before the surgery.

Group Type ACTIVE_COMPARATOR

Intravenous lornoxicam

Intervention Type DRUG

Group II: 8 mg intravenous lornoxicam infusion in 100 ml saline 30 minitues before the surgery.

Paracetamol

Group III: 1 g intravenous paracetamol infusion in 100 ml saline 30 minitues before the surgery.

Group Type ACTIVE_COMPARATOR

Intravenous paracetamol

Intervention Type DRUG

Group III: 1 g intravenous paracetamol infusion in 100 ml saline 30 minitues before the surgery.

Interventions

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

Sterile Saline

Group I: 100 ml intravenous saline infusion as placebo 30 minitues before the surgery.

Intervention Type OTHER

Intravenous lornoxicam

Group II: 8 mg intravenous lornoxicam infusion in 100 ml saline 30 minitues before the surgery.

Intervention Type DRUG

Intravenous paracetamol

Group III: 1 g intravenous paracetamol infusion in 100 ml saline 30 minitues before the surgery.

Intervention Type DRUG

Other Intervention Names

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

Saline Lornoxicam: Xefo Paracetamol: Perfalgan

Eligibility Criteria

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

Inclusion Criteria

* inguinal hernia
* unilateral hernia
* general anesthesia
* elective repair

Exclusion Criteria

* drug allergy
* bilateral hernia
* local anesthesia
* local blockade
* regional anesthesia
* emergency surgery
* complicated hernia
* recurrent hernia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

Diskapi Teaching and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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

Ministry of Health

Principal Investigators

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

Ercan Sonmez, MD

Role: PRINCIPAL_INVESTIGATOR

Diskapi Teaching and Research Hospital

Locations

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

Diskapi Teaching and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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

Turkey (Türkiye)

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Alp Alptekin, MD

Role: primary

+90 312 5962370

Hakan Kulacoglu, MD, FACS

Role: backup

Other Identifiers

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

HerniaAnalgesia2010-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

Tizanidine and Pain After Herniorrhaphy
NCT02016443 COMPLETED PHASE4
QIPB in Inguinal Hernia
NCT06862609 RECRUITING NA
Local Anaesthetic Following Hernia Repair
NCT00471692 TERMINATED PHASE1