NCT06345248

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

April 3, 2024

Status Verified

March 1, 2024

Enrollment Period

1 year

First QC Date

March 28, 2024

Last Update Submit

March 28, 2024

Conditions

Transversus Abdominis Plane

Outcome Measures

Primary Outcomes (1)

  • morphine needed

    mg

    UP TO 24 HOURE

Secondary Outcomes (3)

  • first analgesic request time

    up to 24 hours

  • patients' satisfaction

    UP TO 24 HOURE

  • opioid-associated side effects

    UP TO 24 HOURE

Study Arms (2)

US-TAP group

ACTIVE COMPARATOR
Procedure: US-TAP

LAPTAP group

ACTIVE COMPARATOR
Procedure: LAPTAP

Interventions

US-TAPPROCEDURE

regional block team under ultrasound guidance

US-TAP group
LAPTAPPROCEDURE

performed TAP block under direct visualization with the laparoscope

LAPTAP group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Cairo, 11562, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 28, 2024

First Posted

April 3, 2024

Study Start

April 1, 2024

Primary Completion

April 1, 2025

Study Completion

May 1, 2025

Last Updated

April 3, 2024

Record last verified: 2024-03

Locations

EG(1)