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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- Phase 2
- Phase 3
Contacts et emplacements
Lieux d'étude
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Asyut, Egypte, 71111
- Recrutement
- Assiut University hospital
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Contact:
- Mahmoud Adel Faisal, lecturer
- Numéro de téléphone: 0020 1004391577
- E-mail: dr_mahmoudfaisal@aun.edu.eg
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Chercheur principal:
- Sara Mansour, lecturer
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Chercheur principal:
- Ramy Mostafa Abdel Gawad, lecturer
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur placebo: 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 |
|
Comparateur actif: 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 |
|
Comparateur actif: 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 |
|
Comparateur actif: 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 |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Incidence of postdural puncture headache
Délai: from enrollment to day 15
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patients suffering from PDPH after drug treatment |
from enrollment to day 15
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Total amount of rescue analgesia
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- anesth35/26
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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