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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Control | Placebo Comparator | Group I (Placebo Control) 100 ml intravenous saline infusion as placebo 30 minitues before the surgery. |
|
| Lornoxicam | Active Comparator | Group II: 8 mg intravenous lornoxicam infusion in 100 ml saline 30 minitues before the surgery. |
|
| Paracetamol | Active Comparator | Group III: 1 g intravenous paracetamol infusion in 100 ml saline 30 minitues before the surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sterile Saline | Other | Group I: 100 ml intravenous saline infusion as placebo 30 minitues before the surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain and comfort | 24 and 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative late pain complaint and quality of life | 4. week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ercan Sonmez, MD | Diskapi Teaching and Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diskapi Teaching and Research Hospital | Ankara | Turkey (Türkiye) |
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| Intravenous lornoxicam | Drug | Group II: 8 mg intravenous lornoxicam infusion in 100 ml saline 30 minitues before the surgery. |
|
|
| Intravenous paracetamol | Drug | Group III: 1 g intravenous paracetamol infusion in 100 ml saline 30 minitues before the surgery. |
|
|
| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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