Efficacy of Preventive Ketamine on Postoperative Pain | NCT04908579

Studies
Efficacy of Preventive Ketamine on Postoperative Pain

NCT04908579

Sponsor

Ain Shams University

Status

Recruiting

Last Update Posted

Jul 7, 2026Actual

Enrollment

90Estimated

Phase

Phase 4

Conditions

Postoperative Pain

Interventions

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

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2021Actual

Primary Completion Date

Sep 30, 2026Estimated

Completion Date

Sep 30, 2026Estimated

First Submitted Date

May 27, 2021

First Submission Date that Met QC Criteria

May 27, 2021

First Posted Date

Jun 1, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 3, 2026

Last Update Posted Date

Jul 7, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

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

Lead Sponsor

Ain Shams UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
- 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

Name	Type	Description	Arm Group Labels	Other Names
bupivacaine(intraperitoneally) and ketamine (intraperitoneally)	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to first given rescue analgesia(minutes)	Time to first given rescue analgesia(minutes)	24 hours postoperatively

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ibrahim Mamdouh Esmat	Contact	01001241928		ibrahim_mamdouh@med.asu.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain-Shams University Hospitals	Recruiting	Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

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Browse Branches

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