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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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01069055
Enrollment
60
Registered
2010-02-17
Start date
2010-02-28
Completion date
2010-06-30
Last updated
2010-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia, Postoperative Pain

Keywords

inguinal hernia, surgery, general anesthesia, analgesia, pre-emptive, SF36

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.

Interventions

OTHERSterile Saline

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

DRUGIntravenous lornoxicam

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.

Sponsors

Diskapi Teaching and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Postoperative pain and comfort24 and 48 hours

Secondary

MeasureTime frame
Postoperative late pain complaint and quality of life4. week

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026