NCT05750992

Brief Summary

The aim of this study is to compare Surgical Transversus abdominis plane block and Ultrasound guided transversus abdominis plane block (TAPB) as a postoperative analgesic regimen in female patients undergoing elective cesarean delivery.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Apr 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress83%
Apr 2023Dec 2026

First Submitted

Initial submission to the registry

February 19, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 2, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

April 10, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

January 6, 2026

Status Verified

July 1, 2025

Enrollment Period

3.7 years

First QC Date

February 19, 2023

Last Update Submit

January 4, 2026

Conditions

Cesarean SectionUltrasound Guided Transversus Abdominis Plane BlockSurgical Transversus Abdominis Plane BlockBupivacaineAcute Pain

Outcome Measures

Primary Outcomes (1)

  • Time to perform block.

    The time taken to perform the block will be recorded by an independent observer.

    1 hour postoperatively

Secondary Outcomes (7)

  • Heart rate

    24 hours postoperatively

  • Mean arterial blood pressure

    24 hours postoperatively

  • Pain score

    24 hours postoperatively

  • Time to first analgesic request

    24 hours postoperatively

  • Amount of post operative analgesic consumption

    24 hours postoperatively

  • +2 more secondary outcomes

Study Arms (2)

surgical TAP block

ACTIVE COMPARATOR

twenty-five pregnant women will receive surgical TAP block performed by 40 ml of 0.25% bupivacaine (10 ml 0.5% bupivacaine bilaterally diluted with 10cc normal saline and 100 μg of fentanyl), the total volume was divided equally and administered bilaterally by the surgeon.

Procedure: surgical TAP block

US guided TAP block

ACTIVE COMPARATOR

25 pregnant women will receive US guided T.A.P block performed by 40 ml of 0.25% bupivacaine (10 ml 0.5% bupivacaine bilaterally diluted with 10cc normal saline and 100 μg of fentanyl), the total volume was divided equally and administered bilaterally.

Procedure: US guided TAP block

Interventions

surgical TAP blockPROCEDURE

performed by 40 ml of 0.25% bupivacaine (10 ml 0.5% bupivacaine bilaterally diluted with 10cc normal saline and 100 μg of fentanyl), the total volume was divided equally and administered bilaterally by the surgeon.

Also known as: bupivacaine, normal saline, fentanyl, pethidine
surgical TAP block
US guided TAP blockPROCEDURE

performed by 40 ml of 0.25% bupivacaine (10 ml 0.5% bupivacaine bilaterally diluted with 10cc normal saline and 100 μg of fentanyl), the total volume was divided equally and administered bilaterally.

Also known as: bupivacaine, normal saline, fentanyl , pethidine
US guided TAP block

Eligibility Criteria

Age21 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Full term pregnant women
  • Older than 21 years of age
  • Had elective cesarean section with Pfannenstiel incision.

You may not qualify if:

  • Patients with cesarean section using different surgical incision
  • History of addiction \[including opioids and benzodiazepines\]
  • Allergy to the anesthetic analgesia
  • Psychological disorders
  • Coagulopathies
  • Infection at the block injection site.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kohaf

Cairo, 11865, Egypt

RECRUITING

MeSH Terms

Conditions

Acute Pain

Interventions

BupivacaineSaline SolutionFentanylMeperidine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsonipecotic AcidsAcids, Heterocyclic

Central Study Contacts

Neveen A. Kohaf, Ph.D

CONTACT

+201069482380nevenabdo@azhar.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Clinical Pharmacy

Study Record Dates

First Submitted

February 19, 2023

First Posted

March 2, 2023

Study Start

April 10, 2023

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

January 6, 2026

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

The data will be available upon reasonable request from the principle investigator

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
for one year after completion of the study

Locations

EG(1)