Ultrasound Guided TAPB vs Surgical TAPB With Bupivacaine in Cesarean Section

NCT ID: NCT05750992

Last Updated: 2026-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-10

Study Completion Date

2026-12-30

Brief Summary

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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.

Detailed Description

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Caesarean delivery rates have been increasing worldwide nowadays. At rate of \[52%\], Egypt stands out among countries with the world's highest cesarean delivery percentages . Within the Arab region, rate of cesarean section far higher in Egypt than other Arab countries.

A much simpler and theoretically superior means of establishing a TAP block. When using a transcutaneous (conventional) approach there is always the risk of peritoneal puncture with its attendant complications. Moreover, there are technical difficulties, especially in obese women and the procedure requires specialist equipment, a skilled operator and training in ultrasonography. Our approach obviates these risks and difficulties because the procedure is carried out under direct vision, and it is much easier to perform by the surgeon during caesarean section.

Conditions

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Cesarean Section Ultrasound Guided Transversus Abdominis Plane Block Surgical Transversus Abdominis Plane Block Bupivacaine Acute Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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surgical TAP block

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.

Group Type ACTIVE_COMPARATOR

surgical TAP block

Intervention Type PROCEDURE

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.

US guided TAP block

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.

Group Type ACTIVE_COMPARATOR

US guided TAP block

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

US guided 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.

Intervention Type PROCEDURE

Other Intervention Names

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bupivacaine, normal saline, fentanyl, pethidine bupivacaine, normal saline, fentanyl , pethidine

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Neveen Abd El Maksoad Kohaf

Lecturer of Clinical Pharmacy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kohaf

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Neveen A. Kohaf, Ph.D

Role: CONTACT

+201069482380

Facility Contacts

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Neveen A. Kohaf, Ph.D

Role: primary

01069482380

Other Identifiers

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DFM-IRB 00012367- 23-02-006

Identifier Type: -

Identifier Source: org_study_id

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