Cesarean SectionNCT05750992
Ultrasound Guided TAPB vs Surgical TAPB With Bupivacaine in Cesarean Section
A study testing surgical TAP block and US guided TAP block in people with Cesarean Section and Ultrasound Guided Transversus Abdominis Plane Block, run by Al-Azhar University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 21 to 35 years, women only
- Conditions the study is for
- Cesarean Section, Ultrasound Guided Transversus Abdominis Plane Block, Surgical Transversus Abdominis Plane Block
- What is being tested?
- surgical TAP block and US guided TAP block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2023to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Full term pregnant women
- Older than 21 years of age
- Had elective cesarean section with Pfannenstiel incision.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Kohaf
Cairo, 11865
Neveen A. Kohaf, Ph.D, 01069482380
About this study
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
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.
Read the detailed 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.
- Conditions
- Cesarean Section, Ultrasound Guided Transversus Abdominis Plane Block, Surgical Transversus Abdominis Plane Block, Bupivacaine, Acute Pain
- Being tested
- surgical TAP block, US guided TAP block
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical TAP blockProcedure or surgery
Also called bupivacaine, normal saline, fentanyl, pethidine
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 blockProcedure or surgery
Also called bupivacaine, normal saline, fentanyl , pethidine
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.
| Study group | Role | What they receive |
|---|---|---|
| surgical TAP block | Active comparator | twenty-five pregnant women will receive 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. Receives: Procedure: surgical TAP block |
| US guided TAP block | Active comparator | 25 pregnant women will receive US guided T.A.P 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. Receives: Procedure: US guided TAP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to perform block.
The time taken to perform the block will be recorded by an independent observer.
Measured: 1 hour postoperatively
Secondary outcomes (7)
Heart rate
Patients hemodynamics (heart rate will be recorded)
Measured: 24 hours postoperatively
Mean arterial blood pressure
Patients hemodynamics (mean arterial blood pressure will be recorded)
Measured: 24 hours postoperatively
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').
Measured: 24 hours postoperatively
Time to first analgesic request
The time to first analgesic request will be recorded
Measured: 24 hours postoperatively
Amount of post operative analgesic consumption
The amount of post operative analgesic consumption will be recorded
Measured: 24 hours postoperatively
Time spent in operating room
The time spent in operating room will be recorded
Measured: 24 hours postoperatively
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).
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start10 Apr 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neveen Abd El Maksoad Kohaf, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750992
- Sponsor's protocol ID
- DFM-IRB 00012367- 23-02-006
- Status last verified
- Jul 2025
- First submitted
- 19 Feb 2023
- Last updated
- 6 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon reasonable request from the principle investigator
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05750992
- Acronym / sponsor ID
- DFM-IRB 00012367- 23-02-006
- Conditions
- Cesarean Section, Ultrasound Guided Transversus Abdominis Plane Block, Surgical Transversus Abdominis Plane Block, Bupivacaine, Acute Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 2 Mar 2023 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgical TAP block | Active comparator | Procedure: surgical TAP blocktwenty-five pregnant women will receive 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 | Active comparator | Procedure: US guided TAP block25 pregnant women will receive US guided T.A.P 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. |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Full term pregnant women
- Older than 21 years of age
- Had elective cesarean section with Pfannenstiel incision.
Key exclusion criteria (6 listed)
- Patients with cesarean section using different surgical incision
- History of addiction [including opioids and benzodiazepines]
- Allergy to the anesthetic analgesia
- Psychological disorders
- Coagulopathies
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 |
|---|---|---|
| surgical TAP blockAlso: bupivacaine, normal saline, fentanyl, pethidineperformed 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. | Procedure or surgery | surgical TAP block |
| US guided TAP blockAlso: bupivacaine, normal saline, fentanyl , pethidineperformed 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. | Procedure or surgery | US guided TAP block |
Primary outcome
Time to perform block.
Time frame: 1 hour postoperatively
The time taken to perform the block will be recorded by an independent observer.
7 secondary outcomes
Heart rate
Time frame: 24 hours postoperatively
Mean arterial blood pressure
Time frame: 24 hours postoperatively
Pain score
Time frame: 24 hours postoperatively
Time to first analgesic request
Time frame: 24 hours postoperatively
Amount of post operative analgesic consumption
Time frame: 24 hours postoperatively
Time spent in operating room
Time frame: 24 hours postoperatively
Incidence of Adverse reactions
Time frame: 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon reasonable request from the principle investigator
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgical TAP block and US guided TAP block in people with Cesarean Section and Ultrasound Guided Transversus Abdominis Plane Block, run by Al-Azhar University at 1 site in Egypt.
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 3 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: looking for participants now, as of the sponsor's last update on 6 Jan 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neveen A. Kohaf, Ph.D (+201069482380, nevenabdo@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to perform block. (time frame: 1 hour postoperatively). 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 6 Jan 2026.