Laparoscopic-assisted Versus Ultrasonography-guided Trans... | NCT06345248

Studies
Laparoscopic-assisted Versus Ultrasonography-guided Transversus Abdominis Plane Block in Laparoscopic Sleeve Gastrectomy

NCT06345248

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Apr 3, 2024Actual

Enrollment

74Estimated

Phase

Not Applicable

Conditions

Transversus Abdominis Plane

Interventions

US-TAP
LAPTAP

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

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2024Estimated

Primary Completion Date

Apr 1, 2025Estimated

Completion Date

May 1, 2025Estimated

First Submitted Date

Mar 28, 2024

First Submission Date that Met QC Criteria

Mar 28, 2024

First Posted Date

Apr 3, 2024Actual

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

Mar 28, 2024

Last Update Posted Date

Apr 3, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The transversus abdominis plane (TAP) block, whereby local anesthetic is injected between the internal oblique and transversus abdominis fascia to facilitate blockade of somatic afferents nerves, is an effective, non-narcotic adjunct incorporated into many ERAS protocols. We hypothesized that surgeon delivered LAP-TAPs would be non-inferior to anesthesia-delivered US-TAPs in terms of post-operative pain control

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

74Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
US-TAP group	Active Comparator		Procedure: US-TAP
LAPTAP group	Active Comparator		Procedure: LAPTAP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
US-TAP	Procedure	regional block team under ultrasound guidance	US-TAP group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
morphine needed	mg	UP TO 24 HOURE

Secondary Outcomes

Measure	Description	Time Frame
first analgesic request time	he time elapsed between the end of the operation till the first analgesic dose	up to 24 hours
patients' satisfaction	scale of 1-4 (1, poor; 2, acceptable; 3, satisfactory; and 4, excellent)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Elective laparoscopic sleeve gastrectomy aging > 18years BMI > 40 kg/m2, ASA score I-III

Exclusion Criteria:

history of chronic opioid consumption suffering from contraindications to regional blocks suffering from allergy to study drugs, history of prior complex abdominal wall reconstruction

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 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
Cairo university		Cairo		11562	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Still working

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided