Segmental Thoracic vs Lumbar Spinal: Recovery After Elective Cesarean
Effect of Thoracic Segmental Spinal Anesthesia Versus Conventional Lumbar Spinal Anesthesia on Early Mobilization and Obstetric Quality of Recovery in Elective Cesarean Delivery: A Randomized Controlled Trial
This randomized controlled trial compares thoracic segmental spinal anesthesia (T10-11) with conventional lumbar spinal anesthesia (L4-5) in patients undergoing elective cesarean section. The primary outcome is postoperative quality of recovery assessed with the ObsQoR-11 score. Secondary outcomes include block characteristics (onset time, number of blocked dermatomes, presence of sacral sparing, and postoperative motor block assessed with the Bromage scale), hemodynamic parameters, vasopressor and anticholinergic requirements, perioperative complications, and time to first mobilization.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Cesarean delivery is most commonly performed under lumbar spinal anesthesia. Thoracic segmental spinal anesthesia, performed at a higher interspace, may produce a more segmental block with less lower-limb motor involvement. Evidence in obstetric patients is limited. This trial will test whether the level of spinal injection, with agent, dose, and volume held constant, affects postoperative recovery after elective cesarean delivery.
Prospective, single-center, two-arm, parallel-group randomized controlled trial, 1:1 allocation. (Computer-generated block randomization) Patients and outcome assessors will be masked to allocation; the anesthesiologist performing the block cannot be masked.
All patients will receive isobaric bupivacaine 0.5% 1.5 mL (7.5 mg) with fentanyl 25 mcg (0.5 mL), total volume 2 mL, identical in both arms. Lumbar arm: L4-5 interspace. Thoracic arm: T10-11 interspace. The level will be identified by landmark technique with the patient in the sitting position, using a 26 G pencil-point spinal needle.
Spinal success will be tested by sensory and motor examination. Sensory block (onset, blocked dermatomes, sacral sparing) will be tested with pinprick, and motor block with the modified Bromage scale. Surgery will start when the block reaches T5. In case of a patchy block or inadequate sensory level, conversion to general anesthesia is planned.
Patients will be monitored with standard ASA monitoring. Hypotension will be defined as mean arterial pressure below 60 mmHg or a decrease of more than 20% from baseline, and will be treated with ephedrine 5 mg IV boluses. Bradycardia will be defined as a heart rate below 50 beats/min and will be treated with atropine 0.5 mg IV. Fluid replacement, antiemetic prophylaxis, postoperative analgesia, and the mobilization protocol will be identical in both arms.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: NEZİR YILMAZ, Associate Professor
- Número de teléfono: 05068939496
- Correo electrónico: yilmaznezir@hotmail.com
Criterios de participación
Criterio de elegibilidad
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Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Thoracic segmental spinal anesthesia
Participants allocated to this arm will receive spinal anesthesia at the T10-11 interspace for elective cesarean delivery. After injection, onset time of the block, the number of blocked dermatomes, and the presence or absence of sacral sparing will be recorded, and motor block will be assessed with the modified Bromage scale at predefined intervals during the first 24 postoperative hours . All procedures will be performed by experienced anesthesiologists under standard monitoring. Fluid co-loading, hypotension and bradycardia thresholds with the corresponding vasopressor and atropine |
Spinal anesthesia will be performed at the thoracic interspace (T10-11) |
|
Comparador activo: Lumbar Spinal Anesthesia
Lumbar Spinal Anesthesia Participants in this group will receive conventional spinal anesthesia performed at the lumbar interspace Procedure/Surgery: Lumbar Spinal Anesthesia- (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. |
Participants in this group will receive conventional spinal anesthesia performed at the lumbar interspace ( L4-5) |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Obstetric Quality of Recovery-11 score
Periodo de tiempo: at Postoperative 24th 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. |
at Postoperative 24th hours
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mean arterial pressure
Periodo de tiempo: 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. |
0, 5, 15, 30, 45 minutes intraoperatively
|
|
Heart rate
Periodo de tiempo: 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. |
0. - 5. - 15. - 30. - 45. minutes intraoperatively
|
|
Onset time of sensory block
Periodo de tiempo: Within 15 minutes after completion of intrathecal injection
|
Time from completion of intrathecal injection to loss of sensation to pinprick at the [ T4] dermatome, assessed every 1 minute until the level is reached. |
Within 15 minutes after completion of intrathecal injection
|
|
Number of blocked dermatomes
Periodo de tiempo: 15 minutes after completion of intrathecal injection.
|
Highest and lowest blocked dermatome levels assessed by pinprick testing, and the total number of blocked dermatomes calculated from them. |
15 minutes after completion of intrathecal injection.
|
|
Motor block (modified Bromage scale)
Periodo de tiempo: 1, 2, 4, 6, 12 and 24 hours after surgery
|
Motor block will be assessed with the modified Bromage scale (0 = able to raise the extended leg; 1 = unable to raise the extended leg but able to flex the knee; 2 = unable to flex the knee but able to move the foot; 3 = unable to move the leg or foot). |
1, 2, 4, 6, 12 and 24 hours after surgery
|
|
VAS scores
Periodo de tiempo: 1, 2, 4, 6, 12 and 24 hours after surgery
|
Numeric rating scale (0-10) pain scores at rest and on movement. 0 refer no pain and 10 refer the worst pain |
1, 2, 4, 6, 12 and 24 hours after surgery
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
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Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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Última actualización enviada que cumplió con los criterios de control de calidad
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Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- ADYU-ANS-NY-016
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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