Menu
Not yet recruiting NCT07567612

Thoracic vs Lumbar Spinal Anesthesia for Cesarean Delivery

No phase Interventional Cesarean Sections

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Thoracic Segmental Spinal Anesthesia, Lumbar Spinal Anesthesia.
Who it may be relevant to
Registry conditions: Cesarean Sections. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparison of Thoracic Segmental Spinal Anesthesia Versus Lumbar Spinal Anesthesia on Postoperative Recovery in Patients Undergoing Cesarean Section: A Randomized Controlled Trial

Overview

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.

Interventions

  • 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)
  • Procedure Lumbar Spinal Anesthesia
    Participants in this group will receive conventional spinal anesthesia performed at the lumbar interspace (L3-4 or L4-5)

Primary outcome measures

  • Obstetric Quality of Recovery-11 score [Time frame: Postoperative 24 hours]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Adıyaman University Training and Research Hospital — Adıyaman

Identifiers

NCT: NCT07567612 · ADYU-ANS-NY-013

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗