Lornoxicam vs. Paracetamol After Lower Abdominal Surgery

Study Overview
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Brief Summary
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Background: The aim of this prospective, randomized, double-blind study is to determine the most effective supplemental analgesic, paracetamol or lornoxicam for postoperative pain relief after lower abdominal surgery. Methods: Sixty patients scheduled for lower abdominal surgery under general anesthesia were randomly allocated to receive either isotonic saline (Control group), intravenous paracetamol 1 g every 6 h (Paracetamol group) or lornoxicam 16 mg then 8 mg after 12 h (Lornoxicam group). Additionally pain was treated postoperatively using morphine patient-controlled analgesia. Postoperative pain scores measured by the verbal pain score (VPS), morphine consumption and the incidence of side effects were measured at 1, 2, 4, 8, 12 and 24 hours postoperatively.

Official Title
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Intravenous Lornoxicam is More Effective Than Paracetamol as a Supplemental Analgesic After Lower Abdominal Surgery; A Randomized Controlled Trial

Conditions
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Postoperative Pain

Intervention / Treatment
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* Other: placebo
* Drug: Paracetamol
* Drug: Lornoxicam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: lower abdominal surgery Exclusion Criteria: body weight more than 150% of their ideal body weight history of significant cardiac, pulmonary, renal, hepatic or hematological disease; chronic drug or alcohol abuse; hypersensitivity to any of the studied drugs; bronchial asthma; gastritis or peptic ulcer; and pregnancy patients who received any analgesic drug a day before surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lornoxicam<br>Lornoxicam 16 mg will be given at skin closure and 8 mg will be given 12 hours postoperatively | Drug: Lornoxicam<br>* 16 mg at skin closure and 8 mg 12 hours postoperative<br>* Other names: xefo;|
| Placebo Comparator: Control<br>Patients will receive normal saline at skin closure, at 6, 12, 18 hours postoperatively. | Other: placebo<br>* normal saline<br>* Other names: 0.9 N sodium chloride;|
| Experimental: Paracetamol<br>1 gm of paracetamol will be given at skin closure, 6, 12, 18 hours postoperatively | Drug: Paracetamol<br>* IV paracetamol infusion<br>* Other names: perfalgan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | Postoperative pain scores measured by the verbal pain score (VPS)1, 2, 4, 8, 12 and 24 hours postoperatively. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine consumption | pain was treated postoperatively using morphine patient-controlled analgesia. Morphine consumption was measured at 1, 2, 4, 8, 12 and 24 hours postoperatively | 24 hours | 
| Incidence of side-effects | incidence of side effects was measured at 1,2,4,8, 12, 24 hr postoperatively. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lower abdominal surgery, Paracetamol, Lornoxicam, Morphine