Cesarean SectionNCT06858891
The Effect of TAP Block on Maternal-Infant Bonding
A study testing Transversus abdominis plane (TAP) block in people with Cesarean Section and Transversus Abdominis Plane (TAP) Block, run by Adiyaman University Research Hospital.
Trial summary
Cesarean delivery is a common surgical procedure that is typically performed under spinal anesthesia. Postoperative pain management has a significant impact on both the mother's physical recovery and the quality of maternal-infant bonding. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Section, Transversus Abdominis Plane (TAP) Block
- What is being tested?
- Transversus abdominis plane (TAP) block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- 10 Mar 2025to 10 Apr 2025
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 aged or older patients,
- Agree to participate in the study
- Pregnant women without any maternal or fetal pathology during the pregnancy.
Who cannot join
- <18 age
- Deny to participate in the study
- maternal or fetal pathology during the pregnancy
- Allergy to local anesthetics
- local ingection at block side
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: The Effect of Transversus Abdominis Plane Block on Maternal-Infant Bonding in Cesarean Sections Performed Under Spinal Anesthesia
Cesarean delivery is a common surgical procedure that is typically performed under spinal anesthesia. Postoperative pain management has a significant impact on both the mother's physical recovery and the quality of maternal-infant bonding. The quality of maternal-infant bonding is influenced by various factors, including postoperative pain, early mobilization, initiation of breastfeeding, stress, psychological status, and hormonal balance. Studies have reported that adequate postoperative pain management, early breastfeeding, and early mobilization have positive effects on maternal-infant bonding.
Transversus abdominis plane (TAP) block is a regional anesthesia technique known for its efficacy in controlling postoperative pain. Bilateral TAP block performed after cesarean section has been associated with lower pain scores, reduced analgesic consumption, and shorter hospital stays. However, its impact on maternal-infant bonding has not been fully elucidated.
This study aims to investigate the effect of bilateral TAP block on maternal-infant bonding in women undergoing cesarean section under spinal anesthesia.
Read the detailed description
This study aims to investigate the effect of TAP block on maternal-infant bonding in women undergoing cesarean section under spinal anesthesia. Participants will be randomly assigned to two groups: one group will receive a TAP block in addition to standard care, while the other group will receive only standard pain management. Maternal-infant bonding will be assessed using the maternal bonding scale and behavioral evaluations at 48 hours and one month postpartum.
The primary outcome is to evaluate whether the TAP block improves early bonding by reducing pain and enhancing maternal comfort. Secondary outcomes include maternal pain scores, mobilization time, and initiation of breastfeeding. This study aims to contribute to the optimization of pain management strategies in cesarean deliveries, ultimately improving both maternal recovery and neonatal outcomes.
- Being tested
- Transversus abdominis plane (TAP) block
- Keywords
- cesarean section, Transversus Abdominis Plane (TAP) Block, Maternal-Infant Bonding
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus abdominis plane (TAP) blockProcedure or surgery
Under ultrasound guidance, 20 cc of 0.25% bupivacaine was planned to be administered between the internal oblique and transversus abdominis fascial planes on both lateral aspects of the anterior abdominal wall.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | standard pain management |
| Block group | Experimental | standard pain management + Bilateral TAP block Receives: Procedure: Transversus abdominis plane (TAP) block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Maternal Parenting Self-Efficacy (PMP S-E) score
The PMP S-E is a questionnaire consisting of 18 questions that assess the mother's bond with her baby and her sense of parenthood. Each question consists of 4 options and will be scored on a scale from 0 to 3. The total score of the questionnaire will range from 0 to 54.
Measured: Postoperative 48th hour, based on a single assessment
Secondary outcomes (1)
Visual Analog scale (VAS) score
Postoperative pain scores will be assesed with visual analog scale at postoperative period. Vas score will range to 0-10. O refers to no pain and 10 refers to the worst pain ever had.
Measured: Postoperative 2th, 4th, 6th, 12th and 24th hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start10 Mar 2025 (estimated)
- Primary completion5 Apr 2025 (estimated)
- Study completion10 Apr 2025 (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.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to two groups using the sealed-envelope method: one group will receive bilateral transversus abdominis plane (TAP) block in addition to standard care, while the other group will receive only standard pain management.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adiyaman University Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nezir Yılmaz, Adiyaman University Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858891
- Sponsor's protocol ID
- ADYU-NYILMAZ--007
- Status last verified
- Feb 2025
- First submitted
- 28 Feb 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transversus Abdominis Plane Block on Maternal-Infant Bonding in Cesarean Sections Performed Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT06858891
- Acronym / sponsor ID
- ADYU-NYILMAZ--007
- Keywords
- cesarean section, Transversus Abdominis Plane (TAP) Block, Maternal-Infant Bonding
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Adiyaman University Research HospitalUniversity, hospital or other
- Study start
- 10 Mar 2025 (estimated)
- Primary completion
- 5 Apr 2025 (estimated)
- Study completion
- 10 Apr 2025 (estimated)
- First posted
- 5 Mar 2025 (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 delivery is a common surgical procedure that is typically performed under spinal anesthesia. Postoperative pain management has a significant impact on both the mother's physical recovery and the quality of maternal-infant bonding. The quality of maternal-infant bonding is influenced by various factors, including postoperative pain, early mobilization, initiation of breastfeeding, stress, psychological status, and hormonal balance. Studies have reported that adequate postoperative pain management, early breastfeeding, and early mobilization have positive effects on maternal-infant bonding.
Transversus abdominis plane (TAP) block is a regional anesthesia technique known for its efficacy in controlling postoperative pain. Bilateral TAP block performed after cesarean section has been associated with lower pain scores, reduced analgesic consumption, and shorter hospital stays. However, its impact on maternal-infant bonding has not been fully elucidated.
This study aims to investigate the effect of bilateral TAP block on maternal-infant bonding in women undergoing cesarean section under spinal anesthesia.
Detailed description
This study aims to investigate the effect of TAP block on maternal-infant bonding in women undergoing cesarean section under spinal anesthesia. Participants will be randomly assigned to two groups: one group will receive a TAP block in addition to standard care, while the other group will receive only standard pain management. Maternal-infant bonding will be assessed using the maternal bonding scale and behavioral evaluations at 48 hours and one month postpartum.
The primary outcome is to evaluate whether the TAP block improves early bonding by reducing pain and enhancing maternal comfort. Secondary outcomes include maternal pain scores, mobilization time, and initiation of breastfeeding. This study aims to contribute to the optimization of pain management strategies in cesarean deliveries, ultimately improving both maternal recovery and neonatal outcomes.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to two groups using the sealed-envelope method: one group will receive bilateral transversus abdominis plane (TAP) block in addition to standard care, while the other group will receive only standard pain management.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –standard pain management |
| Block group | Experimental | Procedure: Transversus abdominis plane (TAP) blockstandard pain management + Bilateral TAP block |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 aged or older patients,
- Agree to participate in the study
- Pregnant women without any maternal or fetal pathology during the pregnancy.
Key exclusion criteria (5 listed)
- <18 age
- Deny to participate in the study
- maternal or fetal pathology during the pregnancy
- Allergy to local anesthetics
- local ingection at block side
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 |
|---|---|---|
| Transversus abdominis plane (TAP) blockUnder ultrasound guidance, 20 cc of 0.25% bupivacaine was planned to be administered between the internal oblique and transversus abdominis fascial planes on both lateral aspects of the anterior abdominal wall. | Procedure or surgery | Block group |
Primary outcome
Perceived Maternal Parenting Self-Efficacy (PMP S-E) score
Time frame: Postoperative 48th hour, based on a single assessment
The PMP S-E is a questionnaire consisting of 18 questions that assess the mother's bond with her baby and her sense of parenthood. Each question consists of 4 options and will be scored on a scale from 0 to 3. The total score of the questionnaire will range from 0 to 54.
1 secondary outcome
Visual Analog scale (VAS) score
Time frame: Postoperative 2th, 4th, 6th, 12th and 24th hours
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 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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 study testing Transversus abdominis plane (TAP) block in people with Cesarean Section and Transversus Abdominis Plane (TAP) Block, run by Adiyaman University Research Hospital.
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 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 6 Mar 2025. 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.
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 Nezir Yılmaz, Associate Professor (+905068939496, yilmaznezir@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Maternal Parenting Self-Efficacy (PMP S-E) score (time frame: Postoperative 48th hour, based on a single assessment). 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 Mar 2025.