RecruitingPhase 4NCT04908579

Efficacy of Preventive Ketamine on Postoperative Pain

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

Sponsor

Ain Shams University

Enrollment

90 participants

Start Date

Jun 15, 2021

Study Type

INTERVENTIONAL

Conditions

Postoperative Pain

Summary

* 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.

Eligibility

Min Age: 21 YearsMax Age: 60 Years

Inclusion Criteria2

\- Body mass index \> 35 and \< 60 kg/m2
Either medically free or with well controlled hypertension and/or diabetes.

Exclusion Criteria7

\- 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.

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Interventions

DRUGbupivacaine(intraperitoneally) and ketamine (intraperitoneally)

1. 40 ml volume of bupivacaine 0.25% + ketamine 0.5 mg/kg distributed as 30 ml intraperitoneally and 10 ml as port site infiltration 2. 10 ml normal saline 0.9% will be given intravenous.

DRUGbupivacaine(intraperitoneally) and ketamine (intravenously)

1. 40 ml volume of bupivacaine 0.25% only distributed as 30 ml intraperitoneally and 10 ml as port site infiltration 2. 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.

DRUGbupivacaine(intraperitoneally)

1. 40 ml volume of bupivacaine 0.25% only distributed as 30 ml intraperitoneally and 10 ml as port site infiltration 2. 10 ml normal saline 0.9% will be given intravenous.