NCT07720817

Brief Summary

This study aims to compare and evaluate the safety and efficacy of ultrasound guided retrolaminar block versus transverse abdominis plane block in laparoscopic upper abdominal surgeries. Both RLB and TAP blockade are hypothesized to reduce analgesic consumption, manage pain effectively and minimize side effects but their comparative effectiveness has not yet to be thoroughly explored.

Trial Health

63
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Trial Health Score

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

Enrollment
164

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Jul 2026Feb 2027

First Submitted

Initial submission to the registry

July 1, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

July 15, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 22, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

July 22, 2026

Status Verified

July 1, 2026

Enrollment Period

6 months

First QC Date

July 1, 2026

Last Update Submit

July 17, 2026

Conditions

Retrolaminar BlockTAP BlockLaparoscopic Abdominal Surgeries

Outcome Measures

Primary Outcomes (1)

  • The postoperative Quality of Recovery-15 score

    The Quality of Recovery-15 (QoR-15) questionnaire consists of 15 items. The total score ranges from 0 to 150, with higher scores indicating better postoperative recovery.

    24 hour postoperative

Secondary Outcomes (15)

  • Numeric Rating Scale (NRS) at rest and during coughing

    Immediately after arrival in the post-anesthesia care unit (0 hours), and at 2, 4, 6, 12, and 24 hours after surgery.

  • Total dose of rescue analgesics administered (mg) within the first 24 hours after surgery

    From the end of surgery to 24 hours after surgery.

  • Time to first postoperative opioid analgesic request (hours)

    From the end of surgery until the first request for opioid analgesia, up to 24 hours postoperatively

  • Duration of hospital stay

    From the date of surgery until hospital discharge, assessed for up to 30 days after surgery

  • Mean intraoperative mean arterial pressure (mmHg)

    At baseline (before block), immediately after block (0 minutes), at 5, 10, 20, 30, 60, 90, and 120 minutes after block , or until the end of surgery, whichever occurs first.

  • +10 more secondary outcomes

Study Arms (2)

Retrolaminar Block Group

EXPERIMENTAL

Patients will receive an ultrasound-guided retrolaminar block using 20 ml of 0.25% of bupivacaine administered at the T7 level at both sides

Procedure: Ultrasound-guided Retrolaminar Block group

Transverses Abdominis Plane (TAP) Block Group

ACTIVE COMPARATOR

Patients will receive an ultrasound-guided TAP block using 20 ml of 0.25% bupivacaine at both sids

Procedure: Transverses Abdominis Plane (TAP) Block Group

Interventions

Ultrasound-guided Retrolaminar Block groupPROCEDURE

Ultrasound-guided bilateral retrolaminar block performed before surgery using the study local anesthetic.

Retrolaminar Block Group
Transverses Abdominis Plane (TAP) Block GroupPROCEDURE

Ultrasound-guided bilateral transversus abdominis plane (TAP) block performed before surgery using the study local anesthetic.

Transverses Abdominis Plane (TAP) Block Group

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 21 and 65 years.
  • American Society of Anesthesiologists (ASA) physical status I or II.
  • Body mass index (BMI) less than 30 kg/m².
  • Scheduled for elective laparoscopic upper abdominal surgery under general anesthesia.

You may not qualify if:

  • Refusal to participate in the study.
  • Known allergy or hypersensitivity to any of the study drugs.
  • Infection at the planned block insertion site.
  • Severe uncontrolled cardiac, renal, hepatic, neurological, or respiratory disease.
  • Pre-existing chronic pain.
  • Immunodeficiency.
  • Coagulation abnormalities, anticoagulant therapy, or platelet count less than 80,000/µL.
  • Emergency surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Location

Study Officials

  • hatem saber mohamed ali, Professor

    Faculty of Medicine, Mansoura University

    STUDY CHAIR

  • Naglaa A Elnegeery, Associate Professor

    Faculty of Medicine, Mansoura University

    STUDY CHAIR

  • Ola Shawky Naguib El Nagar, Lecturer

    Faculty of Medicine, Mansoura University

    STUDY DIRECTOR

Central Study Contacts

mohamed elnagar Mohamed A. Elnagar MB BCh, MB BCh

CONTACT

+20 1009344804melnaggar789@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2026

First Posted

July 22, 2026

Study Start

July 15, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

July 22, 2026

Record last verified: 2026-07

Locations

EG(1)