Ultrasound Guided TAPB vs Surgical TAPB With Bupivacaine in Cesarean Section

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Pain; Cesarean Section; Bupivacaine; Ultrasound Guided Transversus Abdominis Plane Block; Surgical Transversus Abdominis Plane Block
• Intervention / Treatment: Procedure: surgical TAP block; Procedure: US guided TAP block

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Neveen A. Kohaf, Ph.D; Phone Number: +201069482380; Email: nevenabdo@azhar.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11865
    • Recruiting
    • Kohaf
    • Contact: Neveen A. Kohaf, Ph.D; Phone Number: 01069482380

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 35 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: 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.; Other Names: bupivacaine, normal saline, fentanyl, pethidine
Active Comparator: 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.	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.; Other Names: bupivacaine, normal saline, fentanyl , pethidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to perform block.	The time taken to perform the block will be recorded by an independent observer.	1 hour postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Patients hemodynamics (heart rate will be recorded)	24 hours postoperatively
Mean arterial blood pressure	Patients hemodynamics (mean arterial blood pressure will be recorded)	24 hours postoperatively
Pain score	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').	24 hours postoperatively
Time to first analgesic request	The time to first analgesic request will be recorded	24 hours postoperatively
Amount of post operative analgesic consumption	The amount of post operative analgesic consumption will be recorded	24 hours postoperatively
Time spent in operating room	The time spent in operating room will be recorded	24 hours postoperatively
Incidence of Adverse reactions	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).	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2023
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: February 19, 2023
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Actual): March 2, 2023

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Bupivacaine; Meperidine
• Other Study ID Numbers: DFM-IRB 00012367- 23-02-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon reasonable request from the principle investigator
• IPD Sharing Time Frame: for one year after completion of the study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No