Caesarean Section; PainNCT05588752
Transverse Abdominal Plane Block for Caesarean
A study testing TAP block in people with Caesarean Section; Pain, run by Université NAZI BONI at 1 site in Burkina Faso.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caesarean Section; Pain
- What is being tested?
- TAP block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBurkina Faso
- Study dates
- 20 Oct 2022to 20 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult parturients (≥ 18 years old) awaiting caesarean section under spinal anesthesia
- ASAI, ASAII
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- TAP block
- Keywords
- Caesarean, TAP-block, Postoperative pain
- Medical subject headings
- Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP blockOther
TAP block under ultrasound
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: TAP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Hours 24 postoperative
Secondary outcomes (4)
Proportion of mild pain at rest in the first 24 postoperative hours
The numerical pain score at rest
Measured: 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
Measured: Hours 48 postoperative
Proportion of nausea-vomiting postoperative during the first 48 hours
At each passage of the nurses
Measured: Hours 48 postoperative
Proportion of maternal satisfaction during the first 48 hours postoperatively
The simple numerical score
Measured: Hours 48 postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start20 Oct 2022
- Primary completion20 Jan 2023
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caesarean Section; PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université NAZI BONI
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismael Guibla, Université NAZI BONI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588752
- Sponsor's protocol ID
- INSSA 2
- Status last verified
- Sep 2023
- First submitted
- 16 Oct 2022
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05588752
- Acronym / sponsor ID
- INSSA 2
- Conditions
- Caesarean Section; Pain
- Keywords
- Caesarean, TAP-block, Postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Université NAZI BONIUniversity, hospital or other
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 20 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| group 1 | No intervention | –will receive at induction of spinal anesthesia 100 µg of morphine |
| group 2 | Experimental | Other: TAP blockNo 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult parturients (≥ 18 years old) awaiting caesarean section under spinal anesthesia
- ASAI, ASAII
Key exclusion criteria (6 listed)
- Lack of informed consent,
- Parturients with cognitive disorders,
- Parturients with notion of chronic pain,
- Allergy to local anesthetics,
- Morphine allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAP blockTAP block under ultrasound | Other | group 2 |
Primary outcome
Proportion of mild pain on mobilization in the first 24 postoperative hours
Time frame: Hours 24 postoperative
The numerical pain score after moving from a lying position to a sitting position
4 secondary outcomes
Proportion of mild pain at rest in the first 24 postoperative hours
Time frame: Hours 24 postoperative
Proportion of mild pain on mobilization in the first 48 postoperative hours
Time frame: Hours 48 postoperative
Proportion of nausea-vomiting postoperative during the first 48 hours
Time frame: Hours 48 postoperative
Proportion of maternal satisfaction during the first 48 hours postoperatively
Time frame: Hours 48 postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAP block in people with Caesarean Section; Pain, run by Université NAZI BONI at 1 site in Burkina Faso.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Burkina Faso. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of mild pain on mobilization in the first 24 postoperative hours (time frame: Hours 24 postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023; AzTrials last refreshed its copy on 28 Oct 2026.