Efficacy of Preventive Ketamine on Postoperative Pain

Sponsor

Ain Shams University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04908579

Collaborator

(none)

Enrollment

Location

Arms

15.5

Anticipated Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: bupivacaine(intraperitoneally) and ketamine (intraperitoneally) Drug: bupivacaine(intraperitoneally) and ketamine (intravenously) Drug: bupivacaine(intraperitoneally)	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jun 15, 2021

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Time to first given rescue analgesia(minutes) [24 hours postoperatively]
Time to first given rescue analgesia(minutes)

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain-Shams University Hospitals	Cairo		Egypt

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr.Ibrahim Mamdouh Esmat, Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt., Ain Shams University

ClinicalTrials.gov Identifier:

NCT04908579

Other Study ID Numbers:

FMASU MD 87/ 2021

First Posted:

Jun 1, 2021

Last Update Posted:

Jun 28, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Ketamine

Bupivacaine

Study Results

No Results Posted as of Jun 28, 2022