Optimal Intrathecal Morphine Dose for Better Post Cesarean Section Analgesia (Analgesia)
27 de abril de 2026 actualizado por: Bashu Dev Parajuli, Tribhuvan University Teaching Hospital, Institute Of Medicine.
Comparison of Postoperative Analgesia With Different Doses of Intrathecal Morphine With Hyperbaric Bupivacaine and Fentanyl in Cesarean Section Patients: A Randomized Controlled Trial
Central neuraxial blocks (CNBs) remain the preferred anesthetic technique for cesarean section, with single shot spinal anesthesia (SSSA) being the standard practice at investigator's institute unless contraindicated. SSSA offers reliable intraoperative anesthesia and provides a few hours of postoperative analgesia. Enhanced recovery after cesarean section protocol has recommended the addition of intrathecal (IT) morphine to improve the postoperative quality of the recovery profile. Fentanyl improves the quality of intraoperative analgesia, while morphine significantly prolongs the postoperative pain relief, often lasting up to 24 hours.
Routine uterine exteriorization, practiced in all cases at investigator's institute, often results in peritoneal stretching pain during surgery. This visceral pain is managed with 10 mcg intrathecal fentanyl added to hyperbaric bupivacaine. For postoperative pain management, the intrathecal morphine is recommended by many guidelines and studies. Intrathecal morphine dose typically ranges from 50 to 300 mcg. The dose of morphine exceeding 150 mcg are usually associated with prolongation of analgesia with higher incidence of side effects like nausea, vomiting and pruritus. In selected cases, investigator had administered morphine 100-150 mcg and the clinical experience has shown reduced postoperative analgesic requirements and favorable recovery profile, with minimal adverse effects.
Despite these promising experiences and extensive literature on IT morphine, their is still lack formal data on the efficacy and safety profile of IT morphine in cesarean section patient. This comparative study will help institute to find the optimum dose of IT morphine with better postoperative analgesia quality with low side effects profile. The finding could serve as a foundation to promote routine use of intrathecal morphine in cesarean section anesthesia at investigator's institute.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Estimado)
180
Fase
- Fase 4
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Bashu Dev Parajuli, MD Anaesthesiology
- Número de teléfono: 00977+ 9851179038
- Correo electrónico: bashuparajuli2012@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Pooja Poudyal, MD Obstetric and Gynaecology
- Número de teléfono: 00977+9841526853
- Correo electrónico: paudyalpooja@yahoo.com
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Pregnant lady > 36 weeks of gestation presenting for cesarean section under spinal anesthesia
- ASA II/ III
- Maternal Height > 150 cm
- BMI< 40 Kg/m2
- Elective Indication
Exclusion Criteria:
- Patient unwilling to take part in the study
- Patient with known allergy to the study medications
- Contraindication to Spinal Anesthesia
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Group BF
Intrathecal drug used: 0.5% hyperbaric bupivacaine 10mg(2ml) with fentanyl 10mcg(0.2ml),
total volume of 2.2ml, single administration, no repetition of intervention In this group, no dose of morphine will be added.
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Spinal anesthesia with 0.5% bupivacaine heavy with fentanyl at L3-L4 intervertebral space using Quincke's spinal needle in sitting position in patients undergoing cesarean section to study the dose with better analgesia profile and lower side effect profile.
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Experimental: Group BF-M50
Intrathecal drug used : 0.5% hyperbaric bupivacaine 10mg(2ml) with fentanyl 10mcg(0.2ml)
plus morphine 50mcg (0.05ml) with total volume of 2.25ml single administration, no repetition of intervention
|
Spinal anesthesia with 0.5% bupivacaine heavy with fentanyl with morphine 50mcg at L3-L4 intervertebral space using Quincke's spinal needle in sitting position in patients undergoing cesarean section to study the dose with better analgesia profile and lower side effect profile.
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Experimental: Group BF-M100
Intrathecal drug used : 0.5% hyperbaric bupivacaine 10mg(2ml) with fentanyl 10mcg(0.2ml)
plus morphine 100mcg (0.1ml) with total volume of 2.3ml single administration, no repetition of intervention
|
Spinal anesthesia with 0.5% bupivacaine heavy with fentanyl with morphine 100mcg at L3-L4 intervertebral space using Quincke's spinal needle in sitting position in patients undergoing cesarean section to study the dose with better analgesia profile and lower side effect profile.
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Experimental: Group BF-M150
Intrathecal drug used : 0.5% hyperbaric bupivacaine 10mg(2ml) with fentanyl 10mcg(0.2ml)
plus morphine 150mcg (0.15ml) with total volume of 2.35ml single administration, no repetition of intervention
|
Spinal anesthesia with 0.5% bupivacaine heavy with fentanyl with morphine 150mcg at L3-L4 intervertebral space using Quincke's spinal needle in sitting position in patients undergoing cesarean section to study the dose with better analgesia profile and lower side effect profile.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
To compare the incidence of postoperative pain after cesarean section with different doses of intrathecal morphine with bupivacaine among the four groups.
Periodo de tiempo: NRS score is measured in recovery room for postoperative pain assessment. This time will be recorded as "time zero". Then in postoperative ward, NRS score is measured at 2 hours, 4 hours, 6 hours, 12 hours and 24 hours from 'time zero".
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The parturient among study groups receiving different dose of intrathecal morphine with bupivacaine were compared for incidence of postoperative cesarean section pain.
The pain is assessed by using Numerical Pain Rating Scale(NRS) ,a 11-point, standardized tool (0-10) in which 0 means "no pain" and 10 means "the worst pain imaginable".
The number of parturient with NRS more than 3 will be compared for postoperative pain among the 4 groups.
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NRS score is measured in recovery room for postoperative pain assessment. This time will be recorded as "time zero". Then in postoperative ward, NRS score is measured at 2 hours, 4 hours, 6 hours, 12 hours and 24 hours from 'time zero".
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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To compare the first rescue analgesia demand time among the four groups
Periodo de tiempo: Postoperative period after cesarean delivery till 24 hour
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Rescue analgesia demand is defined as the first time after the cesarean section when the NRS score > 3, and analgesic will be needed.
The time period after cesarean section when first rescue analgesic is needed will be compared among the four group.
Inj.Ketorolac 30 mg iv will be supplemented first as rescue analgesic and recorded.
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Postoperative period after cesarean delivery till 24 hour
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To compare the total analgesic consumption in first 24 hours among the parturient of four group
Periodo de tiempo: Postoperative total analgesia consumption for first 24 hour
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Total analgesia consumption is defined as the total amount of paracetamol, ketorolac and tramadol received in the first 24 hours.
From the time of first dose of ketorolac, regular analgesia will be prescribed as inj.
ketorolac 30mg iv 8 hourly and inj.
paracetamol 1gm iv 6 hourly for 24 hour.
If the NRS score >3 at any point of time apart from the regular above medication, then Inj.
tramadol 50 mg iv SOS will be provided and recorded.
The number pf parturient with total analgesics consumption in 24 hour will be compared among the four groups.
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Postoperative total analgesia consumption for first 24 hour
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To compare the frequency of rescue analgesia demanded by parturient in first 24 hours among the groups
Periodo de tiempo: Postoperative period for first 24 hour
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Frequency of rescue analgesia demand is measured by number of time patient with NRS >3 who demand for iv ketorolac, paracetamol and tramadol despite providing regular analgesia (inj ketorolac 30mg iv 8 hourly and inj.paracetamol 1gm iv 6 hourly) for 24 hour.
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Postoperative period for first 24 hour
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To compare the incidence of side effects like nausea, vomiting, respiratory depression, level of sedation and pruritus in first 24 hours among the groups
Periodo de tiempo: Postoperative period for first 24 hour
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Number of parturient with treatment related side effects like nausea, vomiting, pruritus, respiratory depression and level of sedation are assessed and compared among the groups. Level of sedation is assessed by Pasero Opioid - Induced Sedation Scale (POSS) This score consist: of : S Sleepy, easy to arouse
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Postoperative period for first 24 hour
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Sultan P, Halpern SH, Pushpanathan E, Patel S, Carvalho B. The Effect of Intrathecal Morphine Dose on Outcomes After Elective Cesarean Delivery: A Meta-Analysis. Anesth Analg. 2016 Jul;123(1):154-64. doi: 10.1213/ANE.0000000000001255.
- Choudhury M. Neuraxial anaesthesia in parturient with cardiac disease. Indian J Anaesth. 2018 Sep;62(9):682-690. doi: 10.4103/ija.IJA_474_18.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de abril de 2026
Finalización primaria (Estimado)
28 de diciembre de 2026
Finalización del estudio (Estimado)
28 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
2 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
27 de abril de 2026
Publicado por primera vez (Actual)
1 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
27 de abril de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Dolor
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Complicaciones Postoperatorias
- Procesos Patológicos
- Manifestaciones neuroconductuales
- Trastornos de la percepción
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Dolor Postoperatorio
- Agnosia
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Compuestos heterocíclicos, anillo fusionado
- Alcaloides
- Hidrocarburos aromáticos policíclicos
- Compuestos policíclicos
- Piperidinas
- Compuestos heterocíclicos, 4 o más anillos
- Morfinanos
- Alcaloides opiáceos
- Compuestos heterocíclicos, anillo puente
- Fenantrenos
- Derivados de morfina
- Morfina
- Fentanilo
Otros números de identificación del estudio
- IRC/IOM/D-2026-339
- NHRC 772-2025 (Otro identificador: NHRC)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Individual patient personal data will be kept confidential as our local IRC won't allow us to breach this policy.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
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