CesareanNCT07916662
Segmental Thoracic vs Lumbar Spinal: Recovery After Elective Cesarean
A study testing Lumbar spinal anesthesia and Thoracic segmental spinal anesthesia in people with Cesarean, run by Adiyaman University Research Hospital.
Trial summary
This randomized controlled trial compares thoracic segmental spinal anesthesia (T10-11) with conventional lumbar spinal anesthesia (L4-5) in patients undergoing elective cesarean section. The primary outcome is postoperative quality of recovery assessed with 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
- What is being tested?
- Lumbar spinal anesthesia and Thoracic segmental spinal anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 5 Nov 2026to 31 Dec 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
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Thoracic Segmental Spinal Anesthesia Versus Conventional Lumbar Spinal Anesthesia on Early Mobilization and Obstetric Quality of Recovery in Elective Cesarean Delivery: A Randomized Controlled Trial
This randomized controlled trial compares thoracic segmental spinal anesthesia (T10-11) with conventional lumbar spinal anesthesia (L4-5) in patients undergoing elective cesarean section. The primary outcome is postoperative quality of recovery assessed with the ObsQoR-11 score. Secondary outcomes include block characteristics (onset time, number of blocked dermatomes, presence of sacral sparing, and postoperative motor block assessed with the Bromage scale), hemodynamic parameters, vasopressor and anticholinergic requirements, perioperative complications, and time to first mobilization.
Read the detailed description
Cesarean delivery is most commonly performed under lumbar spinal anesthesia. Thoracic segmental spinal anesthesia, performed at a higher interspace, may produce a more segmental block with less lower-limb motor involvement. Evidence in obstetric patients is limited. This trial will test whether the level of spinal injection, with agent, dose, and volume held constant, affects postoperative recovery after elective cesarean delivery.
Prospective, single-center, two-arm, parallel-group randomized controlled trial, 1:1 allocation. (Computer-generated block randomization) Patients and outcome assessors will be masked to allocation; the anesthesiologist performing the block cannot be masked.
All patients will receive isobaric bupivacaine 0.5% 1.5 mL (7.5 mg) with fentanyl 25 mcg (0.5 mL), total volume 2 mL, identical in both arms. Lumbar arm: L4-5 interspace. Thoracic arm: T10-11 interspace. The level will be identified by landmark technique with the patient in the sitting position, using a 26 G pencil-point spinal needle.
Spinal success will be tested by sensory and motor examination. Sensory block (onset, blocked dermatomes, sacral sparing) will be tested with pinprick, and motor block with the modified Bromage scale. Surgery will start when the block reaches T5. In case of a patchy block or inadequate sensory level, conversion to general anesthesia is planned.
Patients will be monitored with standard ASA monitoring. Hypotension will be defined as mean arterial pressure below 60 mmHg or a decrease of more than 20% from baseline, and will be treated with ephedrine 5 mg IV boluses. Bradycardia will be defined as a heart rate below 50 beats/min and will be treated with atropine 0.5 mg IV. Fluid replacement, antiemetic prophylaxis, postoperative analgesia, and the mobilization protocol will be identical in both arms.
- Conditions
- Cesarean
- Being tested
- Lumbar spinal anesthesia, Thoracic segmental spinal anesthesia
- Keywords
- Cesarean delivery, quality of recovery, thoracal segmental spinal anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar spinal anesthesiaProcedure or surgery
Participants in this group will receive conventional spinal anesthesia performed at the lumbar interspace ( L4-5)
Thoracic segmental spinal anesthesiaProcedure or surgery
Spinal anesthesia will be performed at the thoracic interspace (T10-11)
| Study group | Role | What they receive |
|---|---|---|
| Thoracic segmental spinal anesthesia | Experimental | Participants allocated to this arm will receive spinal anesthesia at the T10-11 interspace for elective cesarean delivery. After injection, onset time of the block, the number of blocked dermatomes, and the presence or absence of sacral sparing will be recorded, and motor block will be assessed with the modified Bromage scale at predefined intervals during the first 24 postoperative hours . All procedures will be performed by experienced anesthesiologists under standard monitoring. Fluid co-loading, hypotension and bradycardia thresholds with the corresponding vasopressor and atropine Receives: Procedure: Thoracic segmental spinal anesthesia |
| Lumbar Spinal Anesthesia | Active comparator | Lumbar Spinal Anesthesia Participants in this group will receive conventional spinal anesthesia performed at the lumbar interspace Procedure/Surgery: Lumbar Spinal Anesthesia- (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 |
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: at Postoperative 24th hours
Secondary outcomes (6)
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
Onset time of sensory block
Time from completion of intrathecal injection to loss of sensation to pinprick at the [ T4] dermatome, assessed every 1 minute until the level is reached.
Measured: Within 15 minutes after completion of intrathecal injection
Number of blocked dermatomes
Highest and lowest blocked dermatome levels assessed by pinprick testing, and the total number of blocked dermatomes calculated from them.
Measured: 15 minutes after completion of intrathecal injection.
Motor block (modified Bromage scale)
Motor block will be assessed with the modified Bromage scale (0 = able to raise the extended leg; 1 = unable to raise the extended leg but able to flex the knee; 2 = unable to flex the knee but able to move the foot; 3 = unable to move the leg or foot).
Measured: 1, 2, 4, 6, 12 and 24 hours after surgery
VAS scores
Numeric rating scale (0-10) pain scores at rest and on movement. 0 refer no pain and 10 refer the worst pain
Measured: 1, 2, 4, 6, 12 and 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 posted4 Nov 2026
- Study start5 Nov 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CesareanStudies 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
- 100 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
- NCT07916662
- Sponsor's protocol ID
- ADYU-ANS-NY-016
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 4 Nov 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 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Thoracic Segmental Spinal Anesthesia Versus Conventional Lumbar Spinal Anesthesia on Early Mobilization and Obstetric Quality of Recovery in Elective Cesarean Delivery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07916662
- Acronym / sponsor ID
- ADYU-ANS-NY-016
- Conditions
- Cesarean
- Keywords
- Cesarean delivery, quality of recovery, thoracal segmental spinal anesthesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Adiyaman University Research HospitalUniversity, hospital or other
- Study start
- 5 Nov 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Nov 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 compares thoracic segmental spinal anesthesia (T10-11) with conventional lumbar spinal anesthesia (L4-5) in patients undergoing elective cesarean section. The primary outcome is postoperative quality of recovery assessed with the ObsQoR-11 score. Secondary outcomes include block characteristics (onset time, number of blocked dermatomes, presence of sacral sparing, and postoperative motor block assessed with the Bromage scale), hemodynamic parameters, vasopressor and anticholinergic requirements, perioperative complications, and time to first mobilization.
Detailed description
Cesarean delivery is most commonly performed under lumbar spinal anesthesia. Thoracic segmental spinal anesthesia, performed at a higher interspace, may produce a more segmental block with less lower-limb motor involvement. Evidence in obstetric patients is limited. This trial will test whether the level of spinal injection, with agent, dose, and volume held constant, affects postoperative recovery after elective cesarean delivery.
Prospective, single-center, two-arm, parallel-group randomized controlled trial, 1:1 allocation. (Computer-generated block randomization) Patients and outcome assessors will be masked to allocation; the anesthesiologist performing the block cannot be masked.
All patients will receive isobaric bupivacaine 0.5% 1.5 mL (7.5 mg) with fentanyl 25 mcg (0.5 mL), total volume 2 mL, identical in both arms. Lumbar arm: L4-5 interspace. Thoracic arm: T10-11 interspace. The level will be identified by landmark technique with the patient in the sitting position, using a 26 G pencil-point spinal needle.
Spinal success will be tested by sensory and motor examination. Sensory block (onset, blocked dermatomes, sacral sparing) will be tested with pinprick, and motor block with the modified Bromage scale. Surgery will start when the block reaches T5. In case of a patchy block or inadequate sensory level, conversion to general anesthesia is planned.
Patients will be monitored with standard ASA monitoring. Hypotension will be defined as mean arterial pressure below 60 mmHg or a decrease of more than 20% from baseline, and will be treated with ephedrine 5 mg IV boluses. Bradycardia will be defined as a heart rate below 50 beats/min and will be treated with atropine 0.5 mg IV. Fluid replacement, antiemetic prophylaxis, postoperative analgesia, and the mobilization protocol will be identical in both arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracic segmental spinal anesthesia | Experimental | Procedure: Thoracic segmental spinal anesthesiaParticipants allocated to this arm will receive spinal anesthesia at the T10-11 interspace for elective cesarean delivery. After injection, onset time of the block, the number of blocked dermatomes, and the presence or absence of sacral sparing will be recorded, and motor block will be assessed with the modified Bromage scale at predefined intervals during the first 24 postoperative hours . All procedures will be performed by experienced anesthesiologists under standard monitoring. Fluid co-loading, hypotension and bradycardia thresholds with the corresponding vasopressor and atropine |
| Lumbar Spinal Anesthesia | Active comparator | Procedure: Lumbar spinal anesthesiaLumbar Spinal Anesthesia Participants in this group will receive conventional spinal anesthesia performed at the lumbar interspace Procedure/Surgery: Lumbar Spinal Anesthesia- (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. |
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 |
|---|---|---|
| Lumbar spinal anesthesiaParticipants in this group will receive conventional spinal anesthesia performed at the lumbar interspace ( L4-5) | Procedure or surgery | Lumbar Spinal Anesthesia |
| Thoracic segmental spinal anesthesiaSpinal anesthesia will be performed at the thoracic interspace (T10-11) | Procedure or surgery | Thoracic segmental spinal anesthesia |
Primary outcome
Obstetric Quality of Recovery-11 score
Time frame: at Postoperative 24th 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.
6 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
Onset time of sensory block
Time frame: Within 15 minutes after completion of intrathecal injection
Number of blocked dermatomes
Time frame: 15 minutes after completion of intrathecal injection.
Motor block (modified Bromage scale)
Time frame: 1, 2, 4, 6, 12 and 24 hours after surgery
VAS scores
Time frame: 1, 2, 4, 6, 12 and 24 hours after surgery
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 4 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Two Doses of IV Magnesium Sulfate for Prevention of Post-Spinal Shivering
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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 Lumbar spinal anesthesia and Thoracic segmental spinal anesthesia in people with Cesarean, 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 4 Nov 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.
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 (05068939496, 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: at Postoperative 24th 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 4 Nov 2026.