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Thoracic vs Lumbar Spinal Anesthesia for Cesarean Delivery

ConditionCesarean Sections
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorAdiyaman University Research Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pregnant women scheduled for elective cesarean section

ASA II-III

Age 18-45 years

Disqualifiers

Contraindications to spinal anesthesia

Coagulopathy or anticoagulant use

Infection at puncture site

Severe cardiac disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Thoracic Segmental Spinal Anesthesia

    Procedure/Surgery

    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)

  • Lumbar Spinal Anesthesia

    Procedure/Surgery

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Lumbar Spinal AnesthesiaActive comparator 1 intervention
Group B: Thoracic Segmental Spinal AnesthesiaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Postoperative 24 hours

Secondary outcomes

1

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.

Time frame
0, 5, 15, 30, 45 minutes intraoperatively
2

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.

Time frame
0. - 5. - 15. - 30. - 45. minutes intraoperatively
3

Time to first mobilization

Time frame
Up to 24 hours postoperatively

Other outcomes

1

Incidence of nausea and vomiting

Time frame
perioperatively and postoperative first 24 hours
2

Rate of Post-dural puncture headache

Time frame
Postoperative 48 hours

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Adiyaman University Research Hospital

Lead sponsor

Source ClinicalTrials.gov

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