TAP BlockPhase 4NCT07616180
Fixed-Mass Different Volumes Bupivacaine TAP Block After Cesarean
A Phase 4 study testing Bupivacaine in people with TAP Block and Caesarean Section, run by Cairo University.
Trial summary
Cesarean section is commonly associated with moderate to severe postoperative pain, which may delay mobilisation, impair breastfeeding, and affect mother-infant bonding. Although opioids, NSAIDs, and neuraxial techniques are commonly used for post-cesarean analgesia, their side effects have encouraged the use of… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- TAP Block, Caesarean Section, Postoperative Pain
- What is being tested?
- Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 6 Jun 2026to Oct 2026
- Phase
- Phase 4
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- full-term parturients,
- aged > 18 years
- ASA physical status II
- patients who are scheduled for elective CS with Pfannenstiel incisions under spinal anaesthesia.
Who cannot join
- Parturients with contraindications to spinal anaesthesia,
- Having a scar or infection at the site of the block
- BMI > 35 Kg/m2,
- on chronic use of pain medications,
- Refusing to participate.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Ultrasound-guided Transversus Abdominis Plane Block After Cesarean Section Using Two Different Bupivacaine Volumes With a Fixed Drug Mass. A Randomized Comparative Trial.
Cesarean section is commonly associated with moderate to severe postoperative pain, which may delay mobilisation, impair breastfeeding, and affect mother-infant bonding. Although opioids, NSAIDs, and neuraxial techniques are commonly used for post-cesarean analgesia, their side effects have encouraged the use of peripheral nerve blocks such as the transversus abdominis plane block.
The TAP block is a fascial plane block that provides analgesia by depositing local anaesthetic between the internal oblique and transversus abdominis muscles. Its efficacy after cesarean section has been demonstrated, particularly when long-acting intrathecal opioids are not used. However, the optimal local anaesthetic volume and dose remain unclear. Since the TAP block depends on adequate spread of local anaesthetic, larger volumes may improve analgesic coverage, but increasing the dose may raise the risk of systemic toxicity.
Therefore, this study investigates whether using the same fixed mass of bupivacaine in two different volumes affects the analgesic efficacy of TAP block after cesarean section, hypothesising that the larger volume may provide better postoperative analgesia.
- Conditions
- TAP Block, Caesarean Section, Postoperative Pain
- Being tested
- Bupivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Ultrasound-guided bilateral transversus abdominis plane block using 150 mg plain bupivacaine after cesarean section. The same total bupivacaine dose will be administered in two different volumes: 60 mL total volume, 30 mL per side
BupivacaineDrug
Ultrasound-guided bilateral transversus abdominis plane block using 150 mg plain bupivacaine after cesarean section. The same total bupivacaine dose will be administered in two different volumes: 120 mL total volume, 60 mL per side.
| Study group | Role | What they receive |
|---|---|---|
| Fixed-mass, high-volume bupivacaine TAP block | Experimental | Participants will receive a bilateral ultrasound-guided TAP block using 150 mg of plain bupivacaine, diluted to a total volume of 60 mL, injected as 30 mL per side. Receives: Drug: Bupivacaine |
| Fixed-mass, low-volume bupivacaine TAP block | Experimental | Participants will receive a bilateral ultrasound-guided TAP block using 150 mg of plain bupivacaine, diluted to a total volume of 120 mL, injected as 60 mL per side. Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
total postoperative morphine consumption
Measured: first 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 posted1 Jun 2026
- Study start6 Jun 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TAP BlockStudies of the same condition, open and under way.
- More trials run by Cairo 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer Ahmed, MD, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616180
- Sponsor's protocol ID
- MD-185-2023
- Status last verified
- May 2026
- First submitted
- 16 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Transversus Abdominis Plane Block After Cesarean Section Using Two Different Bupivacaine Volumes With a Fixed Drug Mass. A Randomized Comparative Trial.
- ClinicalTrials.gov ID
- NCT07616180
- Acronym / sponsor ID
- MD-185-2023
- Conditions
- TAP Block, Caesarean Section, Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 6 Jun 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 1 Jun 2026 (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 section is commonly associated with moderate to severe postoperative pain, which may delay mobilisation, impair breastfeeding, and affect mother-infant bonding. Although opioids, NSAIDs, and neuraxial techniques are commonly used for post-cesarean analgesia, their side effects have encouraged the use of peripheral nerve blocks such as the transversus abdominis plane block.
The TAP block is a fascial plane block that provides analgesia by depositing local anaesthetic between the internal oblique and transversus abdominis muscles. Its efficacy after cesarean section has been demonstrated, particularly when long-acting intrathecal opioids are not used. However, the optimal local anaesthetic volume and dose remain unclear. Since the TAP block depends on adequate spread of local anaesthetic, larger volumes may improve analgesic coverage, but increasing the dose may raise the risk of systemic toxicity.
Therefore, this study investigates whether using the same fixed mass of bupivacaine in two different volumes affects the analgesic efficacy of TAP block after cesarean section, hypothesising that the larger volume may provide better postoperative analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixed-mass, high-volume bupivacaine TAP block | Experimental | Drug: BupivacaineParticipants will receive a bilateral ultrasound-guided TAP block using 150 mg of plain bupivacaine, diluted to a total volume of 60 mL, injected as 30 mL per side. |
| Fixed-mass, low-volume bupivacaine TAP block | Experimental | Drug: BupivacaineParticipants will receive a bilateral ultrasound-guided TAP block using 150 mg of plain bupivacaine, diluted to a total volume of 120 mL, injected as 60 mL per side. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- full-term parturients,
- aged > 18 years
- ASA physical status II
- patients who are scheduled for elective CS with Pfannenstiel incisions under spinal anaesthesia.
Key exclusion criteria (5 listed)
- Parturients with contraindications to spinal anaesthesia,
- Having a scar or infection at the site of the block
- BMI > 35 Kg/m2,
- on chronic use of pain medications,
- Refusing to participate.
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 |
|---|---|---|
| BupivacaineUltrasound-guided bilateral transversus abdominis plane block using 150 mg plain bupivacaine after cesarean section. The same total bupivacaine dose will be administered in two different volumes: 60 mL total volume, 30 mL per side | Drug | Fixed-mass, high-volume bupivacaine TAP block |
| BupivacaineUltrasound-guided bilateral transversus abdominis plane block using 150 mg plain bupivacaine after cesarean section. The same total bupivacaine dose will be administered in two different volumes: 120 mL total volume, 60 mL per side. | Drug | Fixed-mass, low-volume bupivacaine TAP block |
Primary outcome
total postoperative morphine consumption
Time frame: first 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 1 Jun 2026.
- Individual participant dataSharing planned: No
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Does the Transversus Abdominis Plane(TAP) Block Effectively Manage Pain After Laparoscopic Cholecystectomy?
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Transversalis Fascia Plane Versus Transversus Abdominis Plane Block for Postoperative Analgesia in Children
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine in people with TAP Block and Caesarean Section, run by Cairo University.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Abeer Ahmed, MD (+201005244590, abeer_ahmed@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total postoperative morphine consumption (time frame: first 24 hours 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 1 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.