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

• 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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: bupivacaine(intraperitoneally) and ketamine (intraperitoneally); Drug: bupivacaine(intraperitoneally) and ketamine (intravenously); Drug: bupivacaine(intraperitoneally)

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ibrahim Mamdouh Esmat; Phone Number: 01001241928; Email: ibrahim_mamdouh@med.asu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Ain-Shams University Hospitals
    • Contact: Ibrahim Mamdouh Esmat; Phone Number: 01001241928; Email: ibrahim_mamdouh@med.asu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: - GROUP (I): 30 patients	Drug: bupivacaine(intraperitoneally) and ketamine (intraperitoneally); 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.
Active Comparator: - GROUP (II): 30 patients	Drug: bupivacaine(intraperitoneally) and ketamine (intravenously); 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.
Active Comparator: - GROUP (III) (Control): 30 patients	Drug: bupivacaine(intraperitoneally); 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2021
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: May 27, 2021
• First Submitted That Met QC Criteria: May 27, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Anesthetics, Local; Ketamine; Bupivacaine
• Other Study ID Numbers: FMASU MD 87/ 2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No