Cesarean SectionsNCT07567612
Thoracic vs Lumbar Spinal Anesthesia for Cesarean Delivery
A study testing Thoracic Segmental Spinal Anesthesia and Lumbar Spinal Anesthesia in people with Cesarean Sections, run by Adiyaman University Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to compare the effects of thoracic segmental spinal anesthesia and conventional lumbar spinal anesthesia on postoperative recovery in patients undergoing elective cesarean section. Postoperative recovery will be assessed using the ObsQoR-11 score. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cesarean Sections
- What is being tested?
- Thoracic Segmental Spinal Anesthesia and Lumbar Spinal Anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2026to 15 Jul 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women scheduled for elective cesarean section
- ASA II-III
- Age 18-45 years
Who cannot join
- Contraindications to spinal anesthesia
- Coagulopathy or anticoagulant use
- Infection at puncture site
- Severe cardiac disease
- Patient refusal
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Adıyaman University Training and Research Hospital
Adıyaman, Adıyaman Province, 02200
NEZİR YILMAZ, 05068939496, yilmaznezir@hotmail.com
About this study
Official title: Comparison of Thoracic Segmental Spinal Anesthesia Versus Lumbar Spinal Anesthesia on Postoperative Recovery in Patients Undergoing Cesarean Section: A Randomized Controlled Trial
This randomized controlled trial aims to compare the effects of thoracic segmental spinal anesthesia and conventional lumbar spinal anesthesia on postoperative recovery in patients undergoing elective cesarean section. Postoperative recovery will be assessed using the ObsQoR-11 score. Hemodynamic parameters, vasopressor and anticholinergic requirements, perioperative complications, and mobilization time will also be evaluated.
Read the detailed description
Cesarean delivery is most commonly performed under lumbar spinal anesthesia; however, thoracic segmental spinal anesthesia has emerged as a potential alternative that may provide more segmental block with improved hemodynamic stability and recovery profile. This study will randomize patients to receive either lumbar spinal anesthesia at L3-4 or L4-5 levels or thoracic segmental spinal anesthesia at T10-11 or T11-12 levels. The primary outcome is postoperative recovery assessed by ObsQoR-11. Secondary outcomes include intraoperative hemodynamic changes, vasopressor (ephedrine) and atropine consumption, incidence of nausea and vomiting, post-dural puncture headache, and time to first mobilization.
- Conditions
- Cesarean Sections
- Being tested
- Thoracic Segmental Spinal Anesthesia, Lumbar Spinal Anesthesia
- Keywords
- Thoracic segmental spinal anesthesia, Lumbar spinal anesthesia, cesarean section, Quality of recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic Segmental Spinal AnesthesiaProcedure or surgery
Also called Lumbar Spinal Anesthesia
Thoracic Segmental Spinal Anesthesia: Spinal anesthesia will be performed at the thoracic interspace (T10-11 or T11-12) Lumbar Spinal Anesthesia: Spinal anesthesia will be performed at the lumbar interspace (L3-4 or L4-5)
Lumbar Spinal AnesthesiaProcedure or surgery
Participants in this group will receive conventional spinal anesthesia performed at the lumbar interspace (L3-4 or L4-5)
| Study group | Role | What they receive |
|---|---|---|
| Lumbar Spinal Anesthesia | Active comparator | Participants in this group will receive conventional spinal anesthesia performed at the lumbar interspace (L3-4 or L4-5). The goal is to achieve a standard sensory block level adequate for cesarean delivery. All procedures will be performed by experienced anesthesiologists under standardized conditions. Intraoperative management, including hemodynamic support and fluid administration, will follow the same institutional protocol as in the thoracic group. Receives: Procedure: Lumbar Spinal Anesthesia |
| Thoracic Segmental Spinal Anesthesia | Experimental | Participants allocated to this group will receive spinal anesthesia performed at the thoracic interspace (T10-11 or T11-12). The technique will aim to achieve a segmental sensory block sufficient for cesarean delivery while minimizing cephalad spread. Caudal spread of the local anesthetic will be limited in order to avoid unnecessary lower extremity motor block, thereby potentially facilitating earlier postoperative mobilization. All procedures will be performed by experienced anesthesiologists under standardized monitoring conditions. Intraoperative management, including fluid therapy and vasopressor administration, will be standardized according to institutional protocols. Receives: Procedure: Thoracic Segmental Spinal Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obstetric Quality of Recovery-11 score
Quality of recovery was assessed using the Obstetric Quality of Recovery-11 (ObsQoR-11) questionnaire. Each item is scored from 0 to 10, yielding a total score ranging from 0 to 110, where 110 indicates the best possible recovery and 0 indicates the worst.
Measured: Postoperative 24 hours
Secondary outcomes (3)
Mean arterial pressure
Mean arterial pressure (MAP), defined as the time-weighted average arterial pressure over a single cardiac cycle, was calculated using the standard formula: MAP = [(2 × diastolic blood pressure) + systolic blood pressure] / 3. Continuous or intermittent MAP measurements were used to assess hemodynamic stability and adequacy of organ perfusion throughout the perioperative period. Intraoperative hypotension was predefined as a MAP <6o mmHg.
Measured: 0, 5, 15, 30, 45 minutes intraoperatively
Heart rate
Heart rate (HR), expressed as beats per minute (bpm), was continuously monitored using standard electrocardiography. HR was used as an indicator of autonomic and hemodynamic response throughout the perioperative period. Tachycardia was predefined as HR >100 bpm and bradycardia as HR <50 bpm.
Measured: 0. - 5. - 15. - 30. - 45. minutes intraoperatively
Time to first mobilization
Measured: Up to 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 posted5 May 2026
- Study start5 May 2026 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 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
- NCT07567612
- Sponsor's protocol ID
- ADYU-ANS-NY-013
- Status last verified
- Apr 2026
- First submitted
- 23 Apr 2026
- Last updated
- 5 May 2026
- 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 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Thoracic Segmental Spinal Anesthesia Versus Lumbar Spinal Anesthesia on Postoperative Recovery in Patients Undergoing Cesarean Section: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07567612
- Acronym / sponsor ID
- ADYU-ANS-NY-013
- Conditions
- Cesarean Sections
- Keywords
- Thoracic segmental spinal anesthesia, Lumbar spinal anesthesia, cesarean section, Quality of recovery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Adiyaman University Research HospitalUniversity, hospital or other
- Study start
- 5 May 2026 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 5 May 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.
This randomized controlled trial aims to compare the effects of thoracic segmental spinal anesthesia and conventional lumbar spinal anesthesia on postoperative recovery in patients undergoing elective cesarean section. Postoperative recovery will be assessed using the ObsQoR-11 score. Hemodynamic parameters, vasopressor and anticholinergic requirements, perioperative complications, and mobilization time will also be evaluated.
Detailed description
Cesarean delivery is most commonly performed under lumbar spinal anesthesia; however, thoracic segmental spinal anesthesia has emerged as a potential alternative that may provide more segmental block with improved hemodynamic stability and recovery profile. This study will randomize patients to receive either lumbar spinal anesthesia at L3-4 or L4-5 levels or thoracic segmental spinal anesthesia at T10-11 or T11-12 levels. The primary outcome is postoperative recovery assessed by ObsQoR-11. Secondary outcomes include intraoperative hemodynamic changes, vasopressor (ephedrine) and atropine consumption, incidence of nausea and vomiting, post-dural puncture headache, and time to first mobilization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumbar Spinal Anesthesia | Active comparator | Procedure: Lumbar Spinal AnesthesiaParticipants in this group will receive conventional spinal anesthesia performed at the lumbar interspace (L3-4 or L4-5). The goal is to achieve a standard sensory block level adequate for cesarean delivery. All procedures will be performed by experienced anesthesiologists under standardized conditions. Intraoperative management, including hemodynamic support and fluid administration, will follow the same institutional protocol as in the thoracic group. |
| Thoracic Segmental Spinal Anesthesia | Experimental | Procedure: Thoracic Segmental Spinal AnesthesiaParticipants allocated to this group will receive spinal anesthesia performed at the thoracic interspace (T10-11 or T11-12). The technique will aim to achieve a segmental sensory block sufficient for cesarean delivery while minimizing cephalad spread. Caudal spread of the local anesthetic will be limited in order to avoid unnecessary lower extremity motor block, thereby potentially facilitating earlier postoperative mobilization. All procedures will be performed by experienced anesthesiologists under standardized monitoring conditions. Intraoperative management, including fluid therapy and vasopressor administration, will be standardized according to institutional protocols. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant women scheduled for elective cesarean section
- ASA II-III
- Age 18-45 years
Key exclusion criteria (5 listed)
- Contraindications to spinal anesthesia
- Coagulopathy or anticoagulant use
- Infection at puncture site
- Severe cardiac disease
- Patient refusal
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 |
|---|---|---|
| Thoracic Segmental Spinal AnesthesiaAlso: Lumbar Spinal AnesthesiaThoracic Segmental Spinal Anesthesia: Spinal anesthesia will be performed at the thoracic interspace (T10-11 or T11-12) Lumbar Spinal Anesthesia: Spinal anesthesia will be performed at the lumbar interspace (L3-4 or L4-5) | Procedure or surgery | Thoracic Segmental Spinal Anesthesia |
| Lumbar Spinal AnesthesiaParticipants in this group will receive conventional spinal anesthesia performed at the lumbar interspace (L3-4 or L4-5) | Procedure or surgery | Lumbar Spinal Anesthesia |
Primary outcome
Obstetric Quality of Recovery-11 score
Time frame: Postoperative 24 hours
Quality of recovery was assessed using the Obstetric Quality of Recovery-11 (ObsQoR-11) questionnaire. Each item is scored from 0 to 10, yielding a total score ranging from 0 to 110, where 110 indicates the best possible recovery and 0 indicates the worst.
3 secondary outcomes
Mean arterial pressure
Time frame: 0, 5, 15, 30, 45 minutes intraoperatively
Heart rate
Time frame: 0. - 5. - 15. - 30. - 45. minutes intraoperatively
Time to first mobilization
Time frame: Up to 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 5 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Cesarean Sections
RecruitingObservational study
Anesthetic Technique and Quality of Recovery After Cesarean Delivery
Ceserean Section, Obstetric Quality of Recovery
Not yet recruitingObservational study
Early Heart Rate Variability and Sleep and Quality of Recovery After Cesarean Delivery
Recovery of Function, Postoperative Period
Recruiting
Effects of Rehabilitation on Cesarean Scar Symptoms and Physical Recovery
Cesarean Birth, Massage
Not yet recruiting
Dural Puncture Epidural With 27G vs 26G Needles Versus Standard Epidural for Elective Cesarean Delivery
Cesarean Section, Anesthesia, Obstetrical
Active, not recruiting
Comparison of Prophylactic Continuous Infusion of Norepinephrine, Ephedrine, and Their Combination for Prevention of Hypotension During Spinal Anaesthesia for Caesarean Delivery
Maternal Hypotension After Spinal Anesthesia
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 Thoracic Segmental Spinal Anesthesia and Lumbar Spinal Anesthesia in people with Cesarean Sections, run by Adiyaman University Research Hospital 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 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 5 May 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?
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 NEZİR YILMAZ, 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?
Obstetric Quality of Recovery-11 score (time frame: Postoperative 24 hours). 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 5 May 2026.