Transverse Abdominal Plane Block for Caesarean

NCT05588752 | Completed

• 1 other identifier: INSSA 2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Caesarean Section; Pain

Keywords

Caesarean, TAP-block, Postoperative pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Proportion of mild pain at rest in the first 24 postoperative hours

  Hours 24 postoperative

• Proportion of mild pain on mobilization in the first 48 postoperative hours

  Hours 48 postoperative

• Proportion of nausea-vomiting postoperative during the first 48 hours

  Hours 48 postoperative

• Proportion of maternal satisfaction during the first 48 hours postoperatively

  Hours 48 postoperative

Study Arms (2)

group 1

NO INTERVENTION

will receive at induction of spinal anesthesia 100 µg of morphine

group 2

EXPERIMENTAL

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

Interventions

TAP block OTHER

TAP block under ultrasound

group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Université NAZI BONI: lead

Study Sites (1)

CHU Souro Sanou

Bobo-Dioulasso, Houet, Burkina Faso

Location

MeSH Terms

Conditions

Pain; Pain, Postoperative

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical doctor

Model Details: Patients admitted for caesarean under spinal anesthesia were randomized according to the sealed envelope method into two groups. Group 1 received 100 µg of morphine intrathecally at induction and group 2 a bilateral TAP block at the end of cesarean section with 20 ml of bupivacaine 0.25% and dexamethasone 4 mg in the same syringe on each side.

Study Record Dates

• First Submitted: October 16, 2022
• First Posted: October 20, 2022
• Study Start: October 20, 2022
• Primary Completion: January 20, 2023
• Study Completion: February 20, 2023
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)