Intravenous Ibuprofen Versus Ketorolac in Bariatric Surgery

Study Overview
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Brief Summary
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The aim of the current study is to compare the analgesic effects of both drugs in patients with obesity undergoing bariatric surgery.

Detailed Description
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Upon arrival to the operating room, routine monitors (electrocardiogram, pulse oximetry, and non-invasive blood pressure monitor) will be applied; intravenous line will be secured, and prophylactic antiemetic will be provided in the form of slow intravenous injection of 5 mg dexamethasone drugs. Anesthesia Anesthesia will be induced with 2 mg/kg propofol, 2 mcg/kg fentanyl (lean body weight), and tracheal intubation will be facilitated by 0.6 mg/kg ideal body weight rocuronium after loss of consciousness. Anesthesia will be maintained with isoflurane 1-1.2% in oxygen and 0.1 mg/kg rocuronium every 30 minutes. Fentanyl boluses of 1 mcg/kg will be given if heart rate or/and systolic blood pressure >120% of baseline. Postoperatively, pain assessments using the visual analogue scale (VAS) will be performed at rest and during movement (knee flexion) at 0.5, 4, 10, 18, and 24 h after leaving the operating room. If the VAS score is > 3 intravenous nalbuphine 0.1-0.2 mg/kg (lean body weight) titrated to response with maximum single dose of 20 mg and maximum daily dose of 160 mg. Intravenous ondansetron 4 mg will be given to treat postoperative nausea or vomiting

Official Title
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Intravenous Ibuprofen Versus Ketorolac for Perioperative Pain Control in Morbid Obese Patients Undergoing Bariatric Surgery: a Randomized Controlled Trial

Conditions
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Postoperative Pain, Bariatric Surgery Candidate

Intervention / Treatment
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* Drug: Ketorolac group
* Drug: Ibuprofen group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult (18-65 years) patients body mass index ≥35 kg/m2 scheduled for laparoscopic bariatric surgery Exclusion Criteria: American Society of Anesthesiologists (ASA) physical class IV, severe cardiac comorbidity (impaired contractility with ejection fraction < 50%, heart block, significant arrhythmias, tight valvular lesions), known obstructive sleep apnea or patients with STOP-bang score ≥5, baseline SpO2 <95%, renal impairment, allergy to any of study's drugs, history of gastrointestinal bleeding or ulceration, or inflammatory bowel disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Active Comparator: Ketorolac group<br>ketorolac 30 mg (diluted in 200 mL normal saline) intravenously over 5 minutes | Drug: Ketorolac group<br>* 30 min preoperatively then every 8 hours postoperatively<br>|
| Active Comparator: Ibuprofen group<br>ibuprofen 800 mg intravenously (Diluted in 200 mL of normal saline) over 5 minutes | Drug: Ibuprofen group<br>* 30 min preoperatively then every 8 hours postoperatively<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS | Visual analogue scale | 30 minutes after extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total intraoperative fentanyl | mcg | 30 seconds after skin incision until 1 min after skin closure | 
| post operative nalbuphine | mg | 30 minutes after extubation until 24 hours postoperatively | 
| VAS | Visual analogue scale | at 0.5, 4, 10, 18, and 24 hours after extubation | 
| time to independent movement | defined as time from extubation to be able independently mobile e.g. using the bathroom | 30 minutes after extubation until 24 hours postoperatively |