- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07567612
Thoracic vs Lumbar Spinal Anesthesia for Cesarean Delivery
April 28, 2026 updated by: Nezir Yılmaz, Adiyaman University Research Hospital
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: NEZİR YILMAZ, Associate Professor
- Phone Number: +905068939496
- Email: yilmaznezir@hotmail.com
Study Locations
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Adıyaman Province
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Adıyaman, Adıyaman Province, Turkey (Türkiye), 02200
- Adıyaman University Training and Research Hospital
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Contact:
- NEZİR YILMAZ
- Phone Number: 05068939496
- Email: yilmaznezir@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Pregnant women scheduled for elective cesarean section
- ASA II-III
- Age 18-45 years
Exclusion Criteria:
- Contraindications to spinal anesthesia
- Coagulopathy or anticoagulant use
- Infection at puncture site
- Severe cardiac disease
- Patient refusal
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Lumbar Spinal Anesthesia
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.
|
Participants in this group will receive conventional spinal anesthesia performed at the lumbar interspace (L3-4 or L4-5)
|
|
Experimental: Thoracic Segmental Spinal Anesthesia
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.
|
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)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Postoperative 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean arterial pressure
Time Frame: 0, 5, 15, 30, 45 minutes intraoperatively
|
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.
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0, 5, 15, 30, 45 minutes intraoperatively
|
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Heart rate
Time Frame: 0. - 5. - 15. - 30. - 45. minutes intraoperatively
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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.
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0. - 5. - 15. - 30. - 45. minutes intraoperatively
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Time to first mobilization
Time Frame: Up to 24 hours postoperatively
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Up to 24 hours postoperatively
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Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence of nausea and vomiting
Time Frame: perioperatively and postoperative first 24 hours
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perioperatively and postoperative first 24 hours
|
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Rate of Post-dural puncture headache
Time Frame: Postoperative 48 hours
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Postoperative 48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 5, 2026
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 15, 2026
Study Registration Dates
First Submitted
April 23, 2026
First Submitted That Met QC Criteria
April 28, 2026
First Posted (Actual)
May 5, 2026
Study Record Updates
Last Update Posted (Actual)
May 5, 2026
Last Update Submitted That Met QC Criteria
April 28, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ADYU-ANS-NY-013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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