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NCT Number: NCT05750992

Ultrasound Guided TAPB vs Surgical TAPB With Bupivacaine in Cesarean Section

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.

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Key information

Conditions

Cesarean Section Acute Pain Bupivacaine Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Surgical Transversus Abdominis Plane Block Ultrasound Guided Transversus Abdominis Plane Block

Age range

21 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kohaf

Cairo, 11865, Egypt

Location status: Recruiting

Location contact

Neveen A. Kohaf, Ph.D

CONTACT

01069482380

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Surgical TAP block

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.

Other names: bupivacaine, normal saline, fentanyl, pethidine

US guided TAP block

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.

Other names: bupivacaine, normal saline, fentanyl , pethidine

Primary outcomes

  1. Time to perform block.

    Time frame: 1 hour postoperatively

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

Secondary outcomes

  1. Heart rate

    Time frame: 24 hours postoperatively

    Patients hemodynamics (heart rate will be recorded)

  2. Mean arterial blood pressure

    Time frame: 24 hours postoperatively

    Patients hemodynamics (mean arterial blood pressure will be recorded)

  3. Pain score

    Time frame: 24 hours postoperatively

    The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').

  4. Time to first analgesic request

    Time frame: 24 hours postoperatively

    The time to first analgesic request will be recorded

  5. Amount of post operative analgesic consumption

    Time frame: 24 hours postoperatively

    The amount of post operative analgesic consumption will be recorded

  6. Time spent in operating room

    Time frame: 24 hours postoperatively

    The time spent in operating room will be recorded

  7. Incidence of Adverse reactions

    Time frame: 24 hours postoperatively

    Adverse events will be recorded such as nausea, vomiting, hypotension (Mean arterial blood pressure < 20% of baseline readings and will be managed by ephedrine 5 mg IV and/or normal saline IV) and bradycardia (heart rate < 60 beats/min and will be managed by atropine 0.6 mg IV).

Study contacts

Contact information is provided by the study sponsor or research team.

Neveen A. Kohaf, Ph.D

CONTACT

[email protected]

+201069482380

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Ultrasound Guided Transversus Abdominis Plane Block (TAPB) vs Surgical TAPB With Bupivacaine for Acute Pain Control in Cesarean Section: A Randomized Clinical Trial

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 2, 2023
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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