The Analgesic Efficacy of M-TAPA for Laparoscopic Abdomin... | NCT07540689

Studies
The Analgesic Efficacy of M-TAPA for Laparoscopic Abdominal Surgery in Children

NCT07540689

Sponsor

Kasr El Aini Hospital

Status

Recruiting

Last Update Posted

Apr 23, 2026Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Post Operative Pain

Interventions

port site infiltration
M-TAPA

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

Apr 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

May 2026Estimated

Primary Completion Date

Dec 2026Estimated

Completion Date

Apr 2027Estimated

First Submitted Date

Apr 14, 2026

First Submission Date that Met QC Criteria

Apr 14, 2026

First Posted Date

Apr 20, 2026Actual

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

Apr 20, 2026

Last Update Posted Date

Apr 23, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

This investigation aims to assess the efficacy of M-TAPA in children undergoing laparoscopic abdominal surgery.

Sixty pediatric patients undergoing laparoscopic abdominal surgery under general anesthesia will be enrolled in this single-center study. Preoperatively, participants will be randomly assigned to receive either port-site local anesthetic infiltration or M-TAPA.

Detailed Description

This investigation aims to assess the efficacy of M-TAPA in children undergoing laparoscopic abdominal surgery.

Sixty pediatric patients undergoing laparoscopic abdominal surgery under general anesthesia will be enrolled in this single-center study. Preoperatively, participants will be randomly assigned to a port site local anesthetic infiltration. or M-TAPA.

port-site local anesthetic infiltration Before the skin incision, the surgeon will inject 0.17 mL/kg of 0.25% bupivacaine (up to 2 mg/kg) via infiltration into the skin, subcutaneous tissue, and muscle fascia at the three laparoscopic ports.
M-TAPA. Before skin incision, Ultrasound will be used to perform bilateral M-TAPA.0.25 mL/kg of 0.25% bupivacaine will be administered at each side.

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

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
port site infiltration	Active Comparator	Children will receive port site LA infiltration.	Procedure: port site infiltration
M-TAPA	Active Comparator	Children will receive bilaterall ultrasound guided M-TAPA block.	Procedure: M-TAPA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
port site infiltration	Procedure	children will receive port site LA infiltration.	port site infiltration

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
FLACC pain score	The FLACC (Face, Leg, Activity, Cry, Consolability) pain score ( Each category is scored on a 0-2 scale, which results in a total score of 0-10 0:comfortable, 1-3: mild discomfort, 4-6: moderate discomfort, & 7-10: severe discomfort ) (FLACC) scale pain score at 6 hours.	6 hours postoperatively.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age (1-7) years.
Both genders.
American Society of Anaesthesiologists (ASA) - physical status I-II.
Children undergoing elective laparoscopic abdominal surgery.

Exclusion Criteria:

Parental refusal.
Bleeding disorders with INR > 1.5 and/or platelets < 50 000.
History of allergic reactions to local anesthetics.
Rash or signs of infection at the injection site.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

7 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmed M Elhaddad, Ass.prof.	Contact	01224042847	02	drblacksmith@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kasralainy Hospital	Recruiting	Cairo	Elmanial	11562	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

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Browse Branches

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