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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2010 by Diskapi Teaching and Research Hospital.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01069055
First Posted: February 17, 2010
Last Update Posted: February 24, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Diskapi Teaching and Research Hospital
February 16, 2010
February 17, 2010
February 24, 2010
February 2010
June 2010   (Final data collection date for primary outcome measure)
Postoperative pain and comfort [ Time Frame: 24 and 48 hours ]
Same as current
Complete list of historical versions of study NCT01069055 on ClinicalTrials.gov Archive Site
Postoperative late pain complaint and quality of life [ Time Frame: 4. week ]
Same as current
Not Provided
Not Provided
 
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
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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Inguinal Hernia
  • Postoperative Pain
  • Other: Sterile Saline
    Group I: 100 ml intravenous saline infusion as placebo 30 minitues before the surgery.
    Other Name: Saline
  • Drug: Intravenous lornoxicam
    Group II: 8 mg intravenous lornoxicam infusion in 100 ml saline 30 minitues before the surgery.
    Other Name: Lornoxicam: Xefo
  • Drug: Intravenous paracetamol
    Group III: 1 g intravenous paracetamol infusion in 100 ml saline 30 minitues before the surgery.
    Other Name: Paracetamol: Perfalgan
  • Placebo Comparator: Placebo Control
    Group I (Placebo Control) 100 ml intravenous saline infusion as placebo 30 minitues before the surgery.
    Intervention: Other: Sterile Saline
  • Active Comparator: Lornoxicam
    Group II: 8 mg intravenous lornoxicam infusion in 100 ml saline 30 minitues before the surgery.
    Intervention: Drug: Intravenous lornoxicam
  • Active Comparator: Paracetamol
    Group III: 1 g intravenous paracetamol infusion in 100 ml saline 30 minitues before the surgery.
    Intervention: Drug: Intravenous paracetamol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
60
June 2010
June 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
 
NCT01069055
HerniaAnalgesia2010-001
Yes
Not Provided
Not Provided
Diskapi Teaching and Research Hospital, Ministry of Health
Diskapi Teaching and Research Hospital
Not Provided
Principal Investigator: Ercan Sonmez, MD Diskapi Teaching and Research Hospital
Diskapi Teaching and Research Hospital
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP