Adıyaman University Training and Research Hospital
Adıyaman, Adıyaman Province, 02200, Turkey (Türkiye)
Not Yet Recruiting
NCT Number: NCT07567612
Thoracic vs Lumbar Spinal Anesthesia for Cesarean Delivery
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year–45 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Thoracic Segmental Spinal Anesthesia
ProcedureThoracic 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
Lumbar Spinal Anesthesia
ProcedureParticipants in this group will receive conventional spinal anesthesia performed at the lumbar interspace (L3-4 or L4-5)
Primary outcomes
-
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.
Secondary outcomes
-
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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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.
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Time to first mobilization
Time frame: Up to 24 hours postoperatively
Other outcomes
-
Incidence of nausea and vomiting
Time frame: perioperatively and postoperative first 24 hours
-
Rate of Post-dural puncture headache
Time frame: Postoperative 48 hours
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Adiyaman University Research Hospital
Other
Registry information
Official study title
Comparison of Thoracic Segmental Spinal Anesthesia Versus Lumbar Spinal Anesthesia on Postoperative Recovery in Patients Undergoing Cesarean Section: A Randomized Controlled Trial
Important dates
- Study start
- 2026
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- May 5, 2026
- Registry last updated
- May 5, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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