Transverse Abdominal Plane Block for Caesarean

Efficacy of Transverse Abdominal Plane Block (TAP Block) With Bupivacaine and Dexamethasone for the Management of Post-cesarean Pain at the CHU Sourô Sanou (CHUSS) in Bobo-Dioulasso

Cesarean sectionis a commonly performed major surgical procedure that results in significant postoperative pain. The objective of this study was to evaluate the effectiveness in the management of post-cesarean pain at the CHU Souro Sanou of Bobo-Dioulasso

Study Overview

• Status: Completed
• Conditions: Caesarean Section; Pain
• Intervention / Treatment: Other: TAP block

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Burkina Faso
  • Houet
    • Bobo-Dioulasso, Houet, Burkina Faso
      • CHU Souro Sanou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adult parturients (≥ 18 years old) awaiting caesarean section under spinal anesthesia
• ASAI, ASAII

Exclusion Criteria:

• Lack of informed consent,
• Parturients with cognitive disorders,
• Parturients with notion of chronic pain,
• Allergy to local anesthetics,
• Morphine allergy
• Parturients not understanding pain assessment scores

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: group 1; will receive at induction of spinal anesthesia 100 µg of morphine
Experimental: group 2; No morphine in spinal anesthesia but will receive a bilateral TAP block with 20 ml of Bupivacaine 0.25% and dexamethasone 4 mg in the same syringe on each side	Other: TAP block; TAP block under ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of mild pain on mobilization in the first 24 postoperative hours	The numerical pain score after moving from a lying position to a sitting position	Hours 24 postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of mild pain at rest in the first 24 postoperative hours	The numerical pain score at rest	Hours 24 postoperative
Proportion of mild pain on mobilization in the first 48 postoperative hours	The numerical pain score after moving from a lying position to a sitting position	Hours 48 postoperative
Proportion of nausea-vomiting postoperative during the first 48 hours	At each passage of the nurses	Hours 48 postoperative
Proportion of maternal satisfaction during the first 48 hours postoperatively	The simple numerical score	Hours 48 postoperative

Collaborators and Investigators

• Sponsor: Université NAZI BONI

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2022
• Primary Completion (Actual): January 20, 2023
• Study Completion (Actual): February 20, 2023

Study Registration Dates

• First Submitted: October 16, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 20, 2022

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 3, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Caesarean, TAP-block, Postoperative pain
• Other Study ID Numbers: INSSA 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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