Comparison of Lornoxicam and Paracetamol for Pre-emptive Intravenous Analgesia for Elective Inguinal Hernia Repair
Pre-emptive Intravenous Analgesia for Elective Inguinal Hernia Repair: Prospective Randomized Double-blinded Placebo Controlled Comparison of Lornoxicam and Paracetamol
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2010
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 16, 2010
CompletedFirst Posted
Study publicly available on registry
February 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedFebruary 24, 2010
February 1, 2010
4 months
February 16, 2010
February 23, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative pain and comfort
24 and 48 hours
Secondary Outcomes (1)
Postoperative late pain complaint and quality of life
4. week
Study Arms (3)
Placebo Control
PLACEBO COMPARATORGroup I (Placebo Control) 100 ml intravenous saline infusion as placebo 30 minitues before the surgery.
Lornoxicam
ACTIVE COMPARATORGroup II: 8 mg intravenous lornoxicam infusion in 100 ml saline 30 minitues before the surgery.
Paracetamol
ACTIVE COMPARATORGroup III: 1 g intravenous paracetamol infusion in 100 ml saline 30 minitues before the surgery.
Interventions
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.
Eligibility Criteria
You may qualify if:
- inguinal hernia
- unilateral hernia
- general anesthesia
- elective repair
You may not qualify if:
- drug allergy
- bilateral hernia
- local anesthesia
- local blockade
- regional anesthesia
- emergency surgery
- complicated hernia
- recurrent hernia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Diskapi Teaching and Research Hospital
Ankara, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ercan Sonmez, MD
Diskapi Teaching and Research Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 16, 2010
First Posted
February 17, 2010
Study Start
February 1, 2010
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
February 24, 2010
Record last verified: 2010-02