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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
    • Adıyaman Province
      • Adıyaman, Adıyaman Province, Turkey (Türkiye), 02200
        • Adıyaman University Training and Research Hospital
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Procedure: Lumbar Spinal Anesthesia
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.
Procedure: Thoracic Segmental 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)
Other Names:
  • Lumbar Spinal Anesthesia

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Postoperative 24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
0, 5, 15, 30, 45 minutes intraoperatively
Heart rate
Time Frame: 0. - 5. - 15. - 30. - 45. minutes intraoperatively
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.
0. - 5. - 15. - 30. - 45. minutes intraoperatively
Time to first mobilization
Time Frame: Up to 24 hours postoperatively
Up to 24 hours postoperatively

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Incidence of nausea and vomiting
Time Frame: perioperatively and postoperative first 24 hours
perioperatively and postoperative first 24 hours
Rate of Post-dural puncture headache
Time Frame: Postoperative 48 hours
Postoperative 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Adiyaman University Research Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 5, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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