Efficacy of Preventive Ketamine on Postoperative Pain

NCT04908579 | Recruiting Phase 4

• 1 other identifier: FMASU MD 87/ 2021
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Time to first given rescue analgesia(minutes)

  Time to first given rescue analgesia(minutes)

  24 hours postoperatively

Study Arms (3)

- GROUP (I): 30 patients

ACTIVE COMPARATOR

Drug: bupivacaine(intraperitoneally) and ketamine (intraperitoneally)

- GROUP (II): 30 patients

ACTIVE COMPARATOR

Drug: bupivacaine(intraperitoneally) and ketamine (intravenously)

- GROUP (III) (Control): 30 patients

ACTIVE COMPARATOR

Drug: bupivacaine(intraperitoneally)

Interventions

bupivacaine(intraperitoneally) and ketamine (intravenously) DRUG

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.

- GROUP (II): 30 patients

bupivacaine(intraperitoneally) DRUG

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.

- GROUP (III) (Control): 30 patients

bupivacaine(intraperitoneally) and ketamine (intraperitoneally) DRUG

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.

- GROUP (I): 30 patients

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain-Shams University Hospitals

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Ibrahim Mamdouh Esmat

CONTACT

01001241928; ibrahim_mamdouh@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 1, 2021
• Study Start: June 15, 2021
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)