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
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
60 participants
INTERVENTIONAL
2010-02-28
2010-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Placebo Control
Group I (Placebo Control) 100 ml intravenous saline infusion as placebo 30 minitues before the surgery.
Sterile Saline
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.
Intravenous lornoxicam
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.
Intravenous paracetamol
Group III: 1 g intravenous paracetamol infusion in 100 ml saline 30 minitues before the surgery.
Interventions
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Sterile Saline
Group I: 100 ml intravenous saline infusion as placebo 30 minitues before the surgery.
Intravenous lornoxicam
Group II: 8 mg intravenous lornoxicam infusion in 100 ml saline 30 minitues before the surgery.
Intravenous paracetamol
Group III: 1 g intravenous paracetamol infusion in 100 ml saline 30 minitues before the surgery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* unilateral hernia
* general anesthesia
* elective repair
Exclusion Criteria
* bilateral hernia
* local anesthesia
* local blockade
* regional anesthesia
* emergency surgery
* complicated hernia
* recurrent hernia
18 Years
ALL
No
Sponsors
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Diskapi Teaching and Research Hospital
OTHER
Responsible Party
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Ministry of Health
Principal Investigators
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Ercan Sonmez, MD
Role: PRINCIPAL_INVESTIGATOR
Diskapi Teaching and Research Hospital
Locations
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Diskapi Teaching and Research Hospital
Ankara, , Turkey (Türkiye)
Countries
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Facility Contacts
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Other Identifiers
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HerniaAnalgesia2010-001
Identifier Type: -
Identifier Source: org_study_id
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