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

Postoperative Pain Clinical Trial

Official title:

Pre-emptive Intravenous Analgesia for Elective Inguinal Hernia Repair: Prospective Randomized Double-blinded Placebo Controlled Comparison of Lornoxicam and Paracetamol

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01069055
• Other study ID #: HerniaAnalgesia2010-001
• Status: Not yet recruiting
• Phase: Phase 3
• First received: February 16, 2010
• Last updated: February 23, 2010
• Start date: February 2010
• Est. completion date: June 2010

Study information

• Verified date: February 2010
• Source: Diskapi Teaching and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia
• Pain, Postoperative
• Postoperative Pain

Intervention

Other:
• Sterile Saline
Group I: 100 ml intravenous saline infusion as placebo 30 minitues before the surgery.

Drug:
• 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.

Locations

Country	Name	City	State
Turkey	Diskapi Teaching and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Teaching and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain and comfort		24 and 48 hours	Yes
Secondary	Postoperative late pain complaint and quality of life		4. week	Yes