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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain; Inguinal Hernia
• Intervention / Treatment: Other: Sterile Saline; Drug: Intravenous lornoxicam; Drug: Intravenous paracetamol

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Diskapi Teaching and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Control; Group I (Placebo Control) 100 ml intravenous saline infusion as placebo 30 minitues before the surgery.	Other: Sterile Saline; Group I: 100 ml intravenous saline infusion as placebo 30 minitues before the surgery.; Other Names: Saline
Active Comparator: Lornoxicam; Group II: 8 mg intravenous lornoxicam infusion in 100 ml saline 30 minitues before the surgery.	Drug: Intravenous lornoxicam; Group II: 8 mg intravenous lornoxicam infusion in 100 ml saline 30 minitues before the surgery.; Other Names: Lornoxicam: Xefo
Active Comparator: Paracetamol; Group III: 1 g intravenous paracetamol infusion in 100 ml saline 30 minitues before the surgery.	Drug: Intravenous paracetamol; Group III: 1 g intravenous paracetamol infusion in 100 ml saline 30 minitues before the surgery.; Other Names: Paracetamol: Perfalgan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Postoperative pain and comfort	24 and 48 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Postoperative late pain complaint and quality of life	4. week

Collaborators and Investigators

• Sponsor: Diskapi Teaching and Research Hospital
• Investigators: Principal Investigator: Ercan Sonmez, MD, Diskapi Teaching and Research Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Anticipated): June 1, 2010
• Study Completion (Anticipated): June 1, 2010

Study Registration Dates

• First Submitted: February 16, 2010
• First Submitted That Met QC Criteria: February 16, 2010
• First Posted (Estimate): February 17, 2010

Study Record Updates

• Last Update Posted (Estimate): February 24, 2010
• Last Update Submitted That Met QC Criteria: February 23, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: surgery; general anesthesia; analgesia; inguinal hernia; SF36; pre-emptive
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Acetaminophen; Piroxicam; Lornoxicam
• Other Study ID Numbers: HerniaAnalgesia2010-001