Oral Gabapentin Versus Intravenous Neostigmine/Atropine Versus Combination of Both for Prevention of PDPH
Beyond the Epidural Blood Patch: Combined Oral Gabapentin and Intravenous Neostigmine/Atropine for Prevention of Post Dural Puncture Headache After Cesarean Section Under Spinal Anaesthesia
Post-dural puncture headache (PDPH) is a major complication of neuraxial anaesthesia.
Pain is intense, frontal, throbbing, and radiates to the occiput; it is more severe when standing and less severe when lying down.
A lot of studies reported several techniques for management of post-dural puncture headache including conservative, pharmacological or interventional techniques. Conservative techniques such as hydration and bed rest. These therapies aim to decrease CSF loss through the dural hole and restore CSF with additional fluid intake.
Pharmacological treatment such as caffeine , methylxanthine (as theophylline), gabapentinoids, Sumatriptan, cosyntropin, dexamethasone, intravenous (IV) injection of ondansetron and IV opioid were used. Also, there are several interventional treatments like), epidural blood patch greater occipital nerve block, and sphenopalatine ganglion block has been used.
Neostigmine has a biphasic effect on sympathetic ganglia, ie, depolarization followed by hyperpolarization. results in vasoconstriction reflects sympathetic regulation of the blood supply to cerebral vessels . An increase in central acetylcholine can maintain cerebral vasoconstriction Atropine crosses the blood brain barrier and is a parasympatholytic , it increases CSF secretion by antagonizing the effect of acetylcholine on the choroid plexus Gabapentin is an anti-epileptic, similar in structure to the endogenous neurotransmitter gamma-amino-butyric acid, but their exact mechanism for treating PDPH is unclear.
A possible mechanism for gabapentin-mediated analgesia is the modulation of glutamate receptors (N-methyl-D-aspartate (NMDA) and α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) /kainite). Also it inhibits nociceptive responses to intrathecal NMDA and AMPA in vivo.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Asyut, Egipto, 71111
- Reclutamiento
- Assiut University hospital
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Contacto:
- Mahmoud Adel Faisal, lecturer
- Número de teléfono: 0020 1004391577
- Correo electrónico: dr_mahmoudfaisal@aun.edu.eg
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Investigador principal:
- Sara Mansour, lecturer
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Investigador principal:
- Ramy Mostafa Abdel Gawad, lecturer
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Scheduled for elective CS under spinal anesthesia.
- BMI between 25 and 35 kg/m2.
- ASA 11 primigravida or multigravida.
- Pregnant in a single full-term fetus.
Exclusion Criteria:
- Emergency CS.
- Chronic headache or previous PDPH.
- Any type of chronic pain and those on regular analgesics or anti-epileptic medications.
- Substance abuse.
- Smoking.
- Chronic or gestational hypertension.
- hypersensitivity to one of the used drugs.
- liver, kidney, neurological and psychiatric disorders.
- patient refusal
Plan de estudios
¿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 de placebos: Placebo group
73 participants will receive 10 ml normal saline after fetal delivery + oral placebo tablet by small sip of water 2 hours before admission to the operating room |
using different drugs and different combinations to compare the efficacy of each one to prevent the postdural puncture headache |
|
Comparador activo: Neostigmine group
73 participants will receive (20 μg/kg neostigmine + atropine 0.02 mg / kg) diluted in 10 ml saline after fetal delivery + oral placebo tablet by small sip of water 2 hours before admission to the operating room. |
using different drugs and different combinations to compare the efficacy of each one to prevent the postdural puncture headache |
|
Comparador activo: Gabapentin group
73 participants will receive 10 ml saline after fetal delivery + oral Gabapentin 600 mg by small sip of water 2 hours before admission to the operating room. |
using different drugs and different combinations to compare the efficacy of each one to prevent the postdural puncture headache |
|
Comparador activo: Neostigmine plus gabapentin group
73 participants will receive (20 μg/kg neostigmine+ atropine 0.02 mg / kg) diluted in 10 ml saline after fetal delivery +oral Gabapentin 600 mg by small sip of water 2 hours before admission to the operating room. |
using different drugs and different combinations to compare the efficacy of each one to prevent the postdural puncture headache |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of postdural puncture headache
Periodo de tiempo: from enrollment to day 15
|
patients suffering from PDPH after drug treatment |
from enrollment to day 15
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Total amount of rescue analgesia
Periodo de tiempo: from enrollment to day 15
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amount of analgesia consumed by patients |
from enrollment to day 15
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Severity of PDPH
Periodo de tiempo: from enrollment to day 15
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using NRS (Numerical Rating Scale). |
from enrollment to day 15
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Intraoperative complications
Periodo de tiempo: from enrollment to day 15
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nausea, vomiting, tremors, sedation, ataxia, dizziness, bradycardia, hypotension, muscle cramps, muscle twitches, bronchoconstriction, miosis, Increased Secretions |
from enrollment to day 15
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- anesth35/26
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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