Optimizing Postoperative Pain Control After Laparoscopic... | NCT06007378

Studies
Optimizing Postoperative Pain Control After Laparoscopic Colorectal Surgery

NCT06007378

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Feb 18, 2026Actual

Enrollment

120Actual

Phase

Not Applicable

Conditions

Postoperative Pain

Interventions

Bupivacaine and ketamine
Bupivacaine and transdermal fentanyl patch
Bupivacain

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

Feb 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 5, 2023Actual

Primary Completion Date

Jul 22, 2025Actual

Completion Date

Jul 22, 2025Actual

First Submitted Date

Aug 17, 2023

First Submission Date that Met QC Criteria

Aug 17, 2023

First Posted Date

Aug 23, 2023Actual

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

Feb 16, 2026

Last Update Posted Date

Feb 18, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ibrahim Mamdouh Esmat, Assistant Professor of Anesthesia and Intensive Care, 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

Erector spinae plane block (ESPB) is a novel regional block technique that was proven to have superior outcomes in relieving postoperative pain in colorectal surgeries.Ketamine enhances the impact of local anaesthetics by reducing the duration and extent of motor block while shortening the onset of sensory and motor block.Transdermal Fentanyl Patch (TFP) was better than transdermal buprenorphine in postoperative analgesia following abdominal surgeries.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Bupivacaine and ketamine	Other	Other: Bupivacaine and ketamine
Bupivacaine and transdermal fentanyl patch	Other	Other: Bupivacaine and transdermal fentanyl patch
Bupivacaine	Other	Other: Bupivacain

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bupivacaine and ketamine	Other	Bilateral erector spinae plane block (bupivacaine and ketamine)	Bupivacaine and ketamine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The time to first rescue analgesia after surgery (hour)	The time to first rescue analgesia after surgery (hour)	The first 48 hours after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing laparoscopic colorectal surgery.
American Society of Anesthesiologists (ASA) physical status I or II.

Exclusion Criteria:

Known allergy to one of the study medications.
Skin infections at the site of the needle puncture.
Hepatic, renal or cardiac dysfunction.
Patients diagnosed with obstructive sleep apnoea

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

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

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

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002045	Bupivacaine
D007649	Ketamine

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

Browse Leaves

Not provided

Browse Branches

Not provided