Cesarean Sections
Conditions
Keywords
Thoracic segmental spinal anesthesia, Lumbar spinal anesthesia, cesarean section, Quality of recovery
Brief summary
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
PROCEDUREThoracic 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)
PROCEDURELumbar Spinal Anesthesia
Participants in this group will receive conventional spinal anesthesia performed at the lumbar interspace (L3-4 or L4-5)
Sponsors
Adiyaman University Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the nature of the intervention, the anesthesiologist performing the block cannot be blinded. However, outcome assessment will be conducted by an investigator blinded to group allocation.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Obstetric Quality of Recovery-11 score | 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
| Measure | Time frame | Description |
|---|---|---|
| Mean arterial pressure | 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. |
| Heart rate | 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. |
| Time to first mobilization | Up to 24 hours postoperatively | — |
Countries
Turkey (Türkiye)
Contacts
CONTACTNEZİR YILMAZ, Associate Professor
Outcome results
None listed