Ultrasound Guided TAPB vs Surgical TAPB With Bupivacaine in Cesarean Section

Al-Azhar University

Status: Enrolling

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

Treatments: Procedure: US guided TAP block; Procedure: surgical TAP block

Study type: Interventional

Funder types: Other

Identifiers

NCT05750992

DFM-IRB 00012367- 23-02-006

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 21 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

surgical TAP block

Active Comparator group

Description:

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.

Treatment:

Procedure: surgical TAP block

US guided TAP block

Active Comparator group

Description:

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.

Treatment:

Procedure: US guided TAP block