NCT07567612

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
May 2026Jul 2026

First Submitted

Initial submission to the registry

April 23, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 5, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

May 5, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2026

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

April 23, 2026

Last Update Submit

April 28, 2026

Conditions

Cesarean Sections

Keywords

Thoracic segmental spinal anesthesiaLumbar spinal anesthesiacesarean sectionQuality of recovery

Outcome Measures

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.

    Postoperative 24 hours

Secondary Outcomes (3)

  • Mean arterial pressure

    0, 5, 15, 30, 45 minutes intraoperatively

  • Heart rate

    0. - 5. - 15. - 30. - 45. minutes intraoperatively

  • Time to first mobilization

    Up to 24 hours postoperatively

Other Outcomes (2)

  • Incidence of nausea and vomiting

    perioperatively and postoperative first 24 hours

  • Rate of Post-dural puncture headache

    Postoperative 48 hours

Study Arms (2)

Lumbar Spinal Anesthesia

ACTIVE COMPARATOR

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

Thoracic Segmental Spinal Anesthesia

EXPERIMENTAL

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

Interventions

Thoracic Segmental Spinal AnesthesiaPROCEDURE

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)

Also known as: Lumbar Spinal Anesthesia
Thoracic Segmental Spinal Anesthesia
Lumbar Spinal AnesthesiaPROCEDURE

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

Lumbar Spinal Anesthesia

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale patients scheduled for cesarean section will be enrolled in the study.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women scheduled for elective cesarean section
  • ASA II-III
  • Age 18-45 years

You may not qualify if:

  • Contraindications to spinal anesthesia
  • Coagulopathy or anticoagulant use
  • Infection at puncture site
  • Severe cardiac disease
  • Patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adıyaman University Training and Research Hospital

Adıyaman, Adıyaman Province, 02200, Turkey (Türkiye)

Location

Central Study Contacts

NEZİR YILMAZ, Associate Professor

CONTACT

+905068939496yilmaznezir@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 23, 2026

First Posted

May 5, 2026

Study Start

May 5, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 15, 2026

Last Updated

May 5, 2026

Record last verified: 2026-04

Locations

TU(1)