Pain, PostoperativeNCT07736989
Ultrasound-Guided Bilateral Transversalis Fascia Plane Block With vs Without Dexamethasone for Cesarean Delivery
An observational study of Pain, Postoperative and Analgesia, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
Cesarean delivery is one of the most frequently performed surgical procedures worldwide, and effective postoperative pain management is essential to facilitate early mobilization, maternal-infant bonding, breastfeeding, and overall recovery. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pain, Postoperative, Analgesia
- How many people
- 93 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Aug 2026to 17 Aug 2026
- Phase
- Observational
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Adult women who underwent elective cesarean delivery under spinal anesthesia and received bilateral ultrasound-guided transversalis fascia plane block with or without dexamethasone for postoperative analgesia between November 1, 2025, and June 30, 2026, at our institution.
Who may be able to join
- Female patients aged 18-50 years.
- Elective cesarean delivery performed under spinal anesthesia.
- Bilateral ultrasound-guided transversalis fascia plane block performed for postoperative analgesia.
- Availability of complete perioperative and postoperative follow-up records.
Who cannot join
- Emergency cesarean delivery.
- General anesthesia or combined spinal-epidural anesthesia.
- Contraindication to transversalis fascia plane block.
- Chronic opioid use.
- Allergy to bupivacaine or dexamethasone.
- Missing or incomplete postoperative follow-up data.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bahcesehir Unişversity Medicalpark Goztepe hospital
Istanbul
About this study
Official title: Postoperative Analgesic Outcomes After Bilateral Ultrasound-Guided Transversalis Fascia Plane Block With or Without Dexamethasone in Cesarean Delivery: A Retrospective Cohort Study
Cesarean delivery is one of the most frequently performed surgical procedures worldwide, and effective postoperative pain management is essential to facilitate early mobilization, maternal-infant bonding, breastfeeding, and overall recovery. Ultrasound-guided transversalis fascia plane block (TFPB) has become an increasingly utilized component of multimodal analgesia following cesarean delivery because it provides effective somatic analgesia of the lower anterior abdominal wall. Adjuvants such as dexamethasone are frequently added to local anesthetics with the aim of prolonging block duration and improving postoperative analgesia; however, evidence regarding the clinical benefits of dexamethasone as an adjunct in TFPB remains limited.
At our institution, bilateral ultrasound-guided TFPB is routinely performed for postoperative analgesia in patients undergoing cesarean delivery under spinal anesthesia, provided there is no contraindication and informed consent has been obtained. According to the treating anesthesiologist's routine clinical preference, dexamethasone may be added to the local anesthetic solution in some patients, whereas others receive local anesthetic alone. This retrospective cohort study will review the medical records and postoperative follow-up forms of patients who underwent cesarean delivery between November 1, 2025, and June 30, 2026. Postoperative analgesic outcomes, including opioid consumption, pain scores, time to first analgesic request, postoperative nausea and vomiting, recovery quality, and block-related adverse events, will be compared between patients receiving bilateral TFPB with dexamethasone and those receiving bilateral TFPB without dexamethasone. The findings are expected to provide real-world evidence regarding the potential contribution of dexamethasone to the analgesic efficacy of bilateral TFPB following cesarean delivery.
- Conditions
- Pain, Postoperative, Analgesia
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TFPB + Dexamethasone | Patients who received bilateral ultrasound-guided transversalis fascia plane block with 25 mL of 0.25% bupivacaine per side plus 8 mg dexamethasone for postoperative analgesia following cesarean delivery under spinal anesthesia. | |
| TFPB Alone | Patients who received bilateral ultrasound-guided transversalis fascia plane block with 25 mL of 0.25% bupivacaine per side for postoperative analgesia following cesarean delivery under spinal anesthesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative opioid consumption during the first 24 postoperative hours
Total opioid consumption delivered through the patient-controlled analgesia device during the first 24 hours after surgery, expressed in mg. Patients were instructed to use the PCA device when the Numeric Rating Scale pain score was 4 or higher.
Measured: First 24 hours after surgery
Secondary outcomes (3)
Postoperative pain intensity
Pain intensity assessed using the Numeric Rating Scale (NRS, 0-10).
Measured: 1, 3, 6, 9, 12, 18, and 24 hours after surgery
Time to first analgesic request
Time from completion of surgery to the first patient-controlled analgesia (PCA) demand for postoperative analgesia.
Measured: Within the first 24 postoperative hours
Quality of postoperative recovery
Quality of recovery assessed using the Obstetric Quality of Recovery-10 questionnaire.
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start3 Aug 2026
- Primary completion17 Aug 2026
- Study completion17 Aug 2026
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 Pain, PostoperativeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selma Basyigit, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736989
- Sponsor's protocol ID
- TFPBinCD
- Status last verified
- Aug 2026
- First submitted
- 27 Jul 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cadirci DY, Aydin ME, Ahiskalioglu EO, Celik EC, Yayik AM, Coruh S, Senocak GNC, Ciftci B, Ahiskalioglu A. Intrathecal morphine versus transversalis fascia and transversus abdominis plane blocks combination on obstetric quality of recovery after cesarean delivery: a randomized controlled trial. BMC Anesthesiol. 2025 Dec 17;26(1):46. doi: 10.1186/s12871-025-03559-0.
PubMed 41408168Dost B, DE Cassai A, Bugada D, Balzani E, Karapinar YE, Beldagli M, Ozkal Yalin MS, Tulgar S, Ahiskalioglu A. The analgesic effect of transversalis fascia plane block after cesarean delivery: a systematic review and meta-analysis with trial sequential analysis. Minerva Anestesiol. 2025 Jun;91(6):564-572. doi: 10.23736/S0375-9393.25.18771-3.
PubMed 40693479
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesic Outcomes After Bilateral Ultrasound-Guided Transversalis Fascia Plane Block With or Without Dexamethasone in Cesarean Delivery: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07736989
- Acronym / sponsor ID
- TFPBinCD
- Conditions
- Pain, Postoperative, Analgesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 3 Aug 2026 (actual)
- Primary completion
- 17 Aug 2026 (actual)
- Study completion
- 17 Aug 2026 (actual)
- First posted
- 30 Jul 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 delivery is one of the most frequently performed surgical procedures worldwide, and effective postoperative pain management is essential to facilitate early mobilization, maternal-infant bonding, breastfeeding, and overall recovery. Ultrasound-guided transversalis fascia plane block (TFPB) has become an increasingly utilized component of multimodal analgesia following cesarean delivery because it provides effective somatic analgesia of the lower anterior abdominal wall. Adjuvants such as dexamethasone are frequently added to local anesthetics with the aim of prolonging block duration and improving postoperative analgesia; however, evidence regarding the clinical benefits of dexamethasone as an adjunct in TFPB remains limited.
At our institution, bilateral ultrasound-guided TFPB is routinely performed for postoperative analgesia in patients undergoing cesarean delivery under spinal anesthesia, provided there is no contraindication and informed consent has been obtained. According to the treating anesthesiologist's routine clinical preference, dexamethasone may be added to the local anesthetic solution in some patients, whereas others receive local anesthetic alone. This retrospective cohort study will review the medical records and postoperative follow-up forms of patients who underwent cesarean delivery between November 1, 2025, and June 30, 2026. Postoperative analgesic outcomes, including opioid consumption, pain scores, time to first analgesic request, postoperative nausea and vomiting, recovery quality, and block-related adverse events, will be compared between patients receiving bilateral TFPB with dexamethasone and those receiving bilateral TFPB without dexamethasone. The findings are expected to provide real-world evidence regarding the potential contribution of dexamethasone to the analgesic efficacy of bilateral TFPB following cesarean delivery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TFPB + Dexamethasone | – | –Patients who received bilateral ultrasound-guided transversalis fascia plane block with 25 mL of 0.25% bupivacaine per side plus 8 mg dexamethasone for postoperative analgesia following cesarean delivery under spinal anesthesia. |
| TFPB Alone | – | –Patients who received bilateral ultrasound-guided transversalis fascia plane block with 25 mL of 0.25% bupivacaine per side for postoperative analgesia following cesarean delivery under spinal anesthesia. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adult women who underwent elective cesarean delivery under spinal anesthesia and received bilateral ultrasound-guided transversalis fascia plane block with or without dexamethasone for postoperative analgesia between November 1, 2025, and June 30, 2026, at our institution.
Key inclusion criteria (4 listed)
- Female patients aged 18-50 years.
- Elective cesarean delivery performed under spinal anesthesia.
- Bilateral ultrasound-guided transversalis fascia plane block performed for postoperative analgesia.
- Availability of complete perioperative and postoperative follow-up records.
Key exclusion criteria (6 listed)
- Emergency cesarean delivery.
- General anesthesia or combined spinal-epidural anesthesia.
- Contraindication to transversalis fascia plane block.
- Chronic opioid use.
- Allergy to bupivacaine or dexamethasone.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cumulative opioid consumption during the first 24 postoperative hours
Time frame: First 24 hours after surgery
Total opioid consumption delivered through the patient-controlled analgesia device during the first 24 hours after surgery, expressed in mg. Patients were instructed to use the PCA device when the Numeric Rating Scale pain score was 4 or higher.
3 secondary outcomes
Postoperative pain intensity
Time frame: 1, 3, 6, 9, 12, 18, and 24 hours after surgery
Time to first analgesic request
Time frame: Within the first 24 postoperative hours
Quality of postoperative recovery
Time frame: 24 hours after surgery
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 18 Aug 2026.
- Background: PubMed 41408168Cadirci DY, Aydin ME, Ahiskalioglu EO, Celik EC, Yayik AM, Coruh S, Senocak GNC, Ciftci B, Ahiskalioglu A. Intrathecal morphine versus transversalis fascia and transversus abdominis plane blocks combination on obstetric quality of recovery after cesarean delivery: a randomized controlled trial. BMC Anesthesiol. 2025 Dec 17;26(1):46. doi: 10.1186/s12871-025-03559-0.
- Background: PubMed 40693479Dost B, DE Cassai A, Bugada D, Balzani E, Karapinar YE, Beldagli M, Ozkal Yalin MS, Tulgar S, Ahiskalioglu A. The analgesic effect of transversalis fascia plane block after cesarean delivery: a systematic review and meta-analysis with trial sequential analysis. Minerva Anestesiol. 2025 Jun;91(6):564-572. doi: 10.23736/S0375-9393.25.18771-3.
- 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?
An observational study of Pain, Postoperative and Analgesia, run by Bahçeşehir 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 4 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 18 Aug 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 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?
Cumulative opioid consumption during the first 24 postoperative hours (time frame: First 24 hours after surgery). 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 NCT07736989, 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 18 Aug 2026.