Thoracic vs Lumbar Spinal Anesthesia for Cesarean Delivery
28. april 2026 oppdatert av: Nezir Yılmaz, Adiyaman University Research Hospital
Comparison of Thoracic Segmental Spinal Anesthesia Versus Lumbar Spinal Anesthesia on Postoperative Recovery in Patients Undergoing Cesarean Section: A Randomized Controlled 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
50
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: NEZİR YILMAZ, Associate Professor
- Telefonnummer: +905068939496
- E-post: yilmaznezir@hotmail.com
Studiesteder
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Adıyaman Province
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Adıyaman, Adıyaman Province, Tyrkia (Türkiye), 02200
- Adıyaman University Training and Research Hospital
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Ta kontakt med:
- NEZİR YILMAZ
- Telefonnummer: 05068939496
- E-post: yilmaznezir@hotmail.com
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: Lumbar Spinal Anesthesia
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.
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Participants in this group will receive conventional spinal anesthesia performed at the lumbar interspace (L3-4 or L4-5)
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Eksperimentell: Thoracic Segmental Spinal Anesthesia
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.
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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)
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Obstetric Quality of Recovery-11 score
Tidsramme: Postoperative 24 hours
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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.
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Postoperative 24 hours
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Mean arterial pressure
Tidsramme: 0, 5, 15, 30, 45 minutes intraoperatively
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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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0, 5, 15, 30, 45 minutes intraoperatively
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Heart rate
Tidsramme: 0. - 5. - 15. - 30. - 45. minutes intraoperatively
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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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0. - 5. - 15. - 30. - 45. minutes intraoperatively
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Time to first mobilization
Tidsramme: Up to 24 hours postoperatively
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Up to 24 hours postoperatively
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Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Incidence of nausea and vomiting
Tidsramme: perioperatively and postoperative first 24 hours
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perioperatively and postoperative first 24 hours
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Rate of Post-dural puncture headache
Tidsramme: Postoperative 48 hours
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Postoperative 48 hours
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
5. mai 2026
Primær fullføring (Antatt)
1. juli 2026
Studiet fullført (Antatt)
15. juli 2026
Datoer for studieregistrering
Først innsendt
23. april 2026
Først innsendt som oppfylte QC-kriteriene
28. april 2026
Først lagt ut (Faktiske)
5. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. april 2026
Sist bekreftet
1. april 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- ADYU-ANS-NY-013
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