Ultrasound Guided TAPB vs Surgical TAPB With Bupivacaine in Cesarean Section

Acute Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05750992
• Other study ID #: DFM-IRB 00012367- 23-02-006
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: February 2024
• Source: Al-Azhar University
• Contact: Neveen A. Kohaf, Ph.D
• Phone: +201069482380
• Email: nevenabdo[@]azhar.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Bupivacaine
• Cesarean Section

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Kohaf	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to perform block.	The time taken to perform the block will be recorded by an independent observer.	1 hour postoperatively
Secondary	Heart rate	Patients hemodynamics (heart rate will be recorded)	24 hours postoperatively
Secondary	Mean arterial blood pressure	Patients hemodynamics (mean arterial blood pressure will be recorded)	24 hours postoperatively
Secondary	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
Secondary	Time to first analgesic request	The time to first analgesic request will be recorded	24 hours postoperatively
Secondary	Amount of post operative analgesic consumption	The amount of post operative analgesic consumption will be recorded	24 hours postoperatively
Secondary	Time spent in operating room	The time spent in operating room will be recorded	24 hours postoperatively
Secondary	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