ObstetricNCT06386978
Analgesic Efficacy of Transvers Abdominis Plane Block and Transversalis Fascia Plane Block in Cesarean Section
A study testing Transverse Facia Plane Block (TAP Block) and Transversalis Facia Plane Block (TFP Block) in people with Obstetric, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
This study was designed as a prospective, randomized observational clinical trial. A total of 90 adult women were included in the study performed elective cesarean section. After excluding patients, the care of 90 was included and 3 of these amounts were reserved. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstetric
- What is being tested?
- Transverse Facia Plane Block (TAP Block) and Transversalis Facia Plane Block (TFP Block)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2025to 15 Dec 2025
- 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 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA I and ASA II,
- Pregnant patients accepting spinal anesthesia and procedure
Who cannot join
- Those who are allergic to local anesthetics,
- Those receiving steroid treatment,
- ASA III, ASA IV and ASA V,
- Patients under the age of 18,
- Patients with preeclampsia,
- Eclampsia,
- Placenta percreta and accreta and its complications,
- Emergency patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examination of the Postoperative Analgesic Efficacy of Transvers Abdominis Plane Block and Transversalis Fascia Plane Block in Cesarean Section Surgeries Performed Under Spinal Anesthesia
This study was designed as a prospective, randomized observational clinical trial.
A total of 90 adult women were included in the study performed elective cesarean section.
After excluding patients, the care of 90 was included and 3 of these amounts were reserved.
TAP Block Group (n=30,Group 1): Spinal Anesthesia + TAP block ; TFP Block group (n=30,Group 2): Spinal Anesthesia + TFP block ; Control group (n=30,Group 3); Spinal Anesthesia + No block;
Read the detailed description
This study was designed as a prospective, randomized observational clinical trial. Erciyes University Clinical Research Ethics Board 2024/209.
All participants in the study were adults and their information was confirmed in writing. Preoperative anesthesia assessment was made by an anesthetic injection, cesarean section surgeries for 90 women were planned to be performed on elective conditions among those registered between May 2024 and May 2025. ASA score, anesthesia method, age, weight, height, TAP block group (Group I) or TFP block group (Group II), Control group (Group III) :
Duration of spinal anesthesia, time of first analgesic request, total analgesic consumption for 24-48 hours, VAS score, additional analgesics, patient satisfaction, possible postoperative bleeding, vomiting, heat retention and other interruptions were recorded in the patients.
Those who were allergic to local anesthetics, steroid treatment areas, ASA III, ASA IV and ASA V, patients under the age of 18, preeclampsia, eclampsia, placenta percreta and accreta complications and emergency hospitals were excluded from the study. After excluding patients, the care of 90 was included and 3 of these amounts were reserved.
TAP Block Group (n=30,Group 1): Spinal Anesthesia + TAP block ; TFP Block group (n=30,Group 2): Spinal Anesthesia + TFP block ; Control group (n=30,Group 3): Spinal Anesthesia + No block; At the end of the surgery, TAP (Transverse Abdominis Plane Block) Block or TFP (Transversalis Fascia Plane Block) block was performed under aseptic conditions under ultrasonography guidance.
TAP (Transverse Abdominis Plane Block) Block for Group 1 patients and TFP (Transversalis Fascia Plane Block) block for Group 2 patients on both sides after negative aspiration, with 20 ml 0.25% bupivacaine (Marcaine®, Astra-Zeneca, Turkey) under ultrasonography guidance. It was done under aseptic conditions.
Patients who did not accept both blocks were included in Group 3 (Control group).
All patients were trained on visual analog score (VAS) by the anesthesia assistant during the preoperative evaluation. VAS used for pain assessment, a 10 cm long horizontal line was used.
From 0= (no pain) to 10= (most severe pain).
PCA morphine administration to all patients: The hourly limit was set as 4 mg, and the repeat limit was set as 10 minutes. If the 1 mg IV morphine bolus dose was not sufficient, it was planned to repeat it after 10 minutes, and if it was still not sufficient, paracetamol and diclofenac were planned to be administered.
- Conditions
- Obstetric
- Being tested
- Transverse Facia Plane Block (TAP Block), Transversalis Facia Plane Block (TFP Block), Control
- Keywords
- ceserean section, transverse abdominis plane block, transversalis facia plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transverse Facia Plane Block (TAP Block)Procedure or surgery
Spinal Anesthesia + TAP block
Transversalis Facia Plane Block (TFP Block)Procedure or surgery
Spinal Anesthesia + TFP block
ControlProcedure or surgery
Spinal anesthesia + No block
| Study group | Role | What they receive |
|---|---|---|
| TAP Group | Active comparator | TAP (Transverse Abdominis Plane Block) Block was performed in Group 1 patients after negative aspiration on both sides, under aseptic conditions with bupivacaine under ultrasonography guidance. Receives: Procedure: Transverse Facia Plane Block (TAP Block) |
| TFP Group | Active comparator | TFP (Transversalis facia plane block ) Block was performed in Group 2 patients after negative aspiration on both sides, under aseptic conditions with bupivacaine under ultrasonography guidance. Receives: Procedure: Transversalis Facia Plane Block (TFP Block) |
| Control Group | Active comparator | Patients in the Third group will be considered the control group and no block will be performed Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS score evaluation
A research asistant, bilinded to the group allocation, interviewedpatients and collected data in the24 hours postoperative period. Verbal Analog Pain Scale Score value will be the lowerst 0 and the highest 10. All the highest value, the patient's pain is at its maximum and whether higher scores mean worse outcome.
Measured: 1st, 6th, 12nd, 24 hours at rest, in the first 24hr first day of postoperative period.
Secondary outcomes (1)
time until the first analgesic request
These were the time until the first analgesic request, the number of patients requiring additional analgesics, the general dose of additional analgesic consumption and complications.
Measured: 1st, 6th, 12nd, 24 hours at rest, in the first 24hr first day of postoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start30 May 2025
- Primary completion30 Sep 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObstetricStudies of the same condition, open and under way.
- More trials run by TC Erciyes 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kudret Dogru, TC Erciyes University
- Investigators
- Kudret Dogru, Prof., Principal investigator, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386978
- Sponsor's protocol ID
- 2024/209
- Status last verified
- Dec 2025
- First submitted
- 15 Apr 2024
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Srivastava U, Verma S, Singh TK, Gupta A, Saxsena A, Jagar KD, Gupta M. Efficacy of trans abdominis plane block for post cesarean delivery analgesia: A double-blind, randomized trial. Saudi J Anaesth. 2015 Jul-Sep;9(3):298-302. doi: 10.4103/1658-354X.154732.
PubMed 26240550Aydin ME, Bedir Z, Yayik AM, Celik EC, Ates I, Ahiskalioglu EO, Ahiskalioglu A. Subarachnoid block and ultrasound-guided transversalis fascia plane block for caesarean section: A randomised, double-blind, placebo-controlled trial. Eur J Anaesthesiol. 2020 Sep;37(9):765-772. doi: 10.1097/EJA.0000000000001222.
PubMed 32412986
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Postoperative Analgesic Efficacy of Transvers Abdominis Plane Block and Transversalis Fascia Plane Block in Cesarean Section Surgeries Performed Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT06386978
- Acronym / sponsor ID
- 2024/209
- Conditions
- Obstetric
- Keywords
- ceserean section, transverse abdominis plane block, transversalis facia plane block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 30 May 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 26 Apr 2024 (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.
This study was designed as a prospective, randomized observational clinical trial.
A total of 90 adult women were included in the study performed elective cesarean section.
After excluding patients, the care of 90 was included and 3 of these amounts were reserved.
TAP Block Group (n=30,Group 1): Spinal Anesthesia + TAP block ; TFP Block group (n=30,Group 2): Spinal Anesthesia + TFP block ; Control group (n=30,Group 3); Spinal Anesthesia + No block;
Detailed description
This study was designed as a prospective, randomized observational clinical trial. Erciyes University Clinical Research Ethics Board 2024/209.
All participants in the study were adults and their information was confirmed in writing. Preoperative anesthesia assessment was made by an anesthetic injection, cesarean section surgeries for 90 women were planned to be performed on elective conditions among those registered between May 2024 and May 2025. ASA score, anesthesia method, age, weight, height, TAP block group (Group I) or TFP block group (Group II), Control group (Group III) :
Duration of spinal anesthesia, time of first analgesic request, total analgesic consumption for 24-48 hours, VAS score, additional analgesics, patient satisfaction, possible postoperative bleeding, vomiting, heat retention and other interruptions were recorded in the patients.
Those who were allergic to local anesthetics, steroid treatment areas, ASA III, ASA IV and ASA V, patients under the age of 18, preeclampsia, eclampsia, placenta percreta and accreta complications and emergency hospitals were excluded from the study. After excluding patients, the care of 90 was included and 3 of these amounts were reserved.
TAP Block Group (n=30,Group 1): Spinal Anesthesia + TAP block ; TFP Block group (n=30,Group 2): Spinal Anesthesia + TFP block ; Control group (n=30,Group 3): Spinal Anesthesia + No block; At the end of the surgery, TAP (Transverse Abdominis Plane Block) Block or TFP (Transversalis Fascia Plane Block) block was performed under aseptic conditions under ultrasonography guidance.
TAP (Transverse Abdominis Plane Block) Block for Group 1 patients and TFP (Transversalis Fascia Plane Block) block for Group 2 patients on both sides after negative aspiration, with 20 ml 0.25% bupivacaine (Marcaine®, Astra-Zeneca, Turkey) under ultrasonography guidance. It was done under aseptic conditions.
Patients who did not accept both blocks were included in Group 3 (Control group).
All patients were trained on visual analog score (VAS) by the anesthesia assistant during the preoperative evaluation. VAS used for pain assessment, a 10 cm long horizontal line was used.
From 0= (no pain) to 10= (most severe pain).
PCA morphine administration to all patients: The hourly limit was set as 4 mg, and the repeat limit was set as 10 minutes. If the 1 mg IV morphine bolus dose was not sufficient, it was planned to repeat it after 10 minutes, and if it was still not sufficient, paracetamol and diclofenac were planned to be administered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TAP Group | Active comparator | Procedure: Transverse Facia Plane Block (TAP Block)TAP (Transverse Abdominis Plane Block) Block was performed in Group 1 patients after negative aspiration on both sides, under aseptic conditions with bupivacaine under ultrasonography guidance. |
| TFP Group | Active comparator | Procedure: Transversalis Facia Plane Block (TFP Block)TFP (Transversalis facia plane block ) Block was performed in Group 2 patients after negative aspiration on both sides, under aseptic conditions with bupivacaine under ultrasonography guidance. |
| Control Group | Active comparator | Procedure: ControlPatients in the Third group will be considered the control group and no block will be performed |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ASA I and ASA II,
- Pregnant patients accepting spinal anesthesia and procedure
Key exclusion criteria (8 listed)
- Those who are allergic to local anesthetics,
- Those receiving steroid treatment,
- ASA III, ASA IV and ASA V,
- Patients under the age of 18,
- Patients with preeclampsia,
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 |
|---|---|---|
| Transverse Facia Plane Block (TAP Block)Spinal Anesthesia + TAP block | Procedure or surgery | TAP Group |
| Transversalis Facia Plane Block (TFP Block)Spinal Anesthesia + TFP block | Procedure or surgery | TFP Group |
| ControlSpinal anesthesia + No block | Procedure or surgery | Control Group |
Primary outcome
VAS score evaluation
Time frame: 1st, 6th, 12nd, 24 hours at rest, in the first 24hr first day of postoperative period.
A research asistant, bilinded to the group allocation, interviewedpatients and collected data in the24 hours postoperative period. Verbal Analog Pain Scale Score value will be the lowerst 0 and the highest 10. All the highest value, the patient's pain is at its maximum and whether higher scores mean worse outcome.
1 secondary outcome
time until the first analgesic request
Time frame: 1st, 6th, 12nd, 24 hours at rest, in the first 24hr first day of postoperative period
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 23 Dec 2025.
- Background: PubMed 26240550Srivastava U, Verma S, Singh TK, Gupta A, Saxsena A, Jagar KD, Gupta M. Efficacy of trans abdominis plane block for post cesarean delivery analgesia: A double-blind, randomized trial. Saudi J Anaesth. 2015 Jul-Sep;9(3):298-302. doi: 10.4103/1658-354X.154732.
- Background: PubMed 32412986Aydin ME, Bedir Z, Yayik AM, Celik EC, Ates I, Ahiskalioglu EO, Ahiskalioglu A. Subarachnoid block and ultrasound-guided transversalis fascia plane block for caesarean section: A randomised, double-blind, placebo-controlled trial. Eur J Anaesthesiol. 2020 Sep;37(9):765-772. doi: 10.1097/EJA.0000000000001222.
- Individual participant dataSharing planned: No
Related trials for Obstetric
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
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.
Kudret Dogru, Prof. principal investigator
TC Erciyes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transverse Facia Plane Block (TAP Block) and Transversalis Facia Plane Block (TFP Block) in people with Obstetric, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 8 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 23 Dec 2025. 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 Turkey (Türkiye). 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?
VAS score evaluation (time frame: 1st, 6th, 12nd, 24 hours at rest, in the first 24hr first day of postoperative period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06386978, which also lists 2 linked publications.
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 23 Dec 2025.