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

Primary Purpose

Inguinal Hernia, Postoperative Pain

Status
Unknown status
Phase
Phase 3
Locations
Turkey
Study Type
Interventional
Intervention
Sterile Saline
Intravenous lornoxicam
Intravenous paracetamol
Sponsored by
Diskapi Teaching and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Inguinal Hernia focused on measuring inguinal hernia, surgery, general anesthesia, analgesia, pre-emptive, SF36

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Diskapi Teaching and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Placebo Control

Lornoxicam

Paracetamol

Arm Description

Group I (Placebo Control) 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.

Outcomes

Primary Outcome Measures

Postoperative pain and comfort

Secondary Outcome Measures

Postoperative late pain complaint and quality of life

Full Information

First Posted
February 16, 2010
Last Updated
February 23, 2010
Sponsor
Diskapi Teaching and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01069055
Brief Title
Comparison of Lornoxicam and Paracetamol for Pre-emptive Intravenous Analgesia for Elective Inguinal Hernia Repair
Official Title
Pre-emptive Intravenous Analgesia for Elective Inguinal Hernia Repair: Prospective Randomized Double-blinded Placebo Controlled Comparison of Lornoxicam and Paracetamol
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
February 2010 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
June 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Diskapi Teaching and Research Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia, Postoperative Pain
Keywords
inguinal hernia, surgery, general anesthesia, analgesia, pre-emptive, SF36

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo Control
Arm Type
Placebo Comparator
Arm Description
Group I (Placebo Control) 100 ml intravenous saline infusion as placebo 30 minitues before the surgery.
Arm Title
Lornoxicam
Arm Type
Active Comparator
Arm Description
Group II: 8 mg intravenous lornoxicam infusion in 100 ml saline 30 minitues before the surgery.
Arm Title
Paracetamol
Arm Type
Active Comparator
Arm Description
Group III: 1 g intravenous paracetamol infusion in 100 ml saline 30 minitues before the surgery.
Intervention Type
Other
Intervention Name(s)
Sterile Saline
Other Intervention Name(s)
Saline
Intervention Description
Group I: 100 ml intravenous saline infusion as placebo 30 minitues before the surgery.
Intervention Type
Drug
Intervention Name(s)
Intravenous lornoxicam
Other Intervention Name(s)
Lornoxicam: Xefo
Intervention Description
Group II: 8 mg intravenous lornoxicam infusion in 100 ml saline 30 minitues before the surgery.
Intervention Type
Drug
Intervention Name(s)
Intravenous paracetamol
Other Intervention Name(s)
Paracetamol: Perfalgan
Intervention Description
Group III: 1 g intravenous paracetamol infusion in 100 ml saline 30 minitues before the surgery.
Primary Outcome Measure Information:
Title
Postoperative pain and comfort
Time Frame
24 and 48 hours
Secondary Outcome Measure Information:
Title
Postoperative late pain complaint and quality of life
Time Frame
4. week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ercan Sonmez, MD
Organizational Affiliation
Diskapi Teaching and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diskapi Teaching and Research Hospital
City
Ankara
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alp Alptekin, MD
Phone
+90 312 5962370
Email
alptekinmd@yahoo.com
First Name & Middle Initial & Last Name & Degree
Hakan Kulacoglu, MD, FACS
Email
hakankulacoglu@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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