Transverse Abdominal Plane Block for Caesarean

Sponsor

Université NAZI BONI (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05588752

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

24.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Caesarean Section; Pain	Other: TAP block	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Oct 20, 2022

Anticipated Primary Completion Date :

Jan 20, 2023

Anticipated Study Completion Date :

Feb 20, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Proportion of mild pain on mobilization in the first 24 postoperative hours [Hours 24 postoperative]
The numerical pain score after moving from a lying position to a sitting position

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Souro Sanou	Bobo-Dioulasso	Houet	Burkina Faso

Sponsors and Collaborators

Université NAZI BONI

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ismael Guibla, Clinical doctor, Université NAZI BONI

ClinicalTrials.gov Identifier:

NCT05588752

Other Study ID Numbers:

INSSA 2

First Posted:

Oct 20, 2022

Last Update Posted:

Oct 20, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ismael Guibla, Clinical doctor, Université NAZI BONI

Caesarean, TAP-block, Postoperative pain

Study Results

No Results Posted as of Oct 20, 2022