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Clinical Trials in Egypt / NCT04908579
Recruiting Phase 4

Efficacy of Preventive Ketamine on Postoperative Pain

NCT04908579 · tracked via the Priya Life Science Egypt tracker
Phase
Phase 4
Started
2021-06-15
Last updated
2026-07-07

Condition(s) studied

Postoperative Pain

Investigational drug(s) / intervention(s)

bupivacaine(intraperitoneally) and ketamine (intraperitoneally) →bupivacaine(intraperitoneally) and ketamine (intravenously) →bupivacaine(intraperitoneally) →

bupivacaine(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.

bupivacaine(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.

bupivacaine(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.

Study 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

Sex
ALL
Min age
21 Years
Max age
60 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Ain-Shams University Hospitals Cairo Egypt Recruiting

More Ain Shams University trials in Egypt

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04908579 on ClinicalTrials.gov ↗ ← All trials in Egypt