Efficacy of Preventive Ketamine on Postoperative Pain

Study Overview
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Brief Summary
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Although bariatric surgery is mainly performed laparoscopically, analgesic optimization is still essential to reduce complications and to improve the patients' comfort. In laparoscopic sleeve gastrectomy, the intraoperative peritoneal instillation of bupivacaine hydrochloride (30 ml, 0.25%) was known to be safe and effective in reducing postoperative pain, nausea, and vomiting. Furthermore, usage of ketamine both as a pre and post-operative pain management is well established. Ketamine can be used solely or in combination with other co-adjuvant drugs, increasing their efficacy. Many therapeutic properties of ketamine have been attributed to its antagonism mechanism to N-Methyl-D-aspartate receptors.

Official Title
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Efficacy of Preventive Ketamine on Postoperative Pain: A Randomized, Double-blind Trial of Patients Undergoing Laparoscopic Sleeve Gastrectomy

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: bupivacaine(intraperitoneally) and ketamine (intraperitoneally)
* Drug: bupivacaine(intraperitoneally) and ketamine (intravenously)
* Drug: bupivacaine(intraperitoneally)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Body mass index > 35 and < 60 kg/m2 Either medically free or with well controlled hypertension and/or diabetes. Exclusion Criteria: - Patient's refusal to participate in the study BMI > 60 kg/m2. Age less than 21 years. Patients with severe systemic disease which is not life-threatening. Patients on antipsychotics, antidepressants and/or corticosteroids. Patients with history of obstructive sleep apnea. Allergic reaction to any of the study medications.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: - GROUP (I): 30 patients<br> | Drug: bupivacaine(intraperitoneally) and ketamine (intraperitoneally)<br>* 40 ml volume of bupivacaine 0.25% + ketamine 0.5 mg/kg distributed as 30 ml intraperitoneally and 10 ml as port site infiltration 10 ml normal saline 0.9% will be given intravenous.<br>|
| Active Comparator: - GROUP (II): 30 patients<br> | Drug: bupivacaine(intraperitoneally) and ketamine (intravenously)<br>* 40 ml volume of bupivacaine 0.25% only distributed as 30 ml intraperitoneally and 10 ml as port site infiltration 10 ml volume of ketamine 0.5 mg/kg intravenously will be given after delivering the gastric sleeve and before start closure of port sites.<br>|
| Active Comparator: - GROUP (III) (Control): 30 patients<br> | Drug: bupivacaine(intraperitoneally)<br>* 40 ml volume of bupivacaine 0.25% only distributed as 30 ml intraperitoneally and 10 ml as port site infiltration 10 ml normal saline 0.9% will be given intravenous.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first given rescue analgesia(minutes) | Time to first given rescue analgesia(minutes) | 24 hours postoperatively |