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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 2
- Fas 3
Kontakter och platser
Studieorter
-
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Asyut, Egypten, 71111
- Rekrytering
- Assiut University hospital
-
Kontakt:
- Mahmoud Adel Faisal, lecturer
- Telefonnummer: 0020 1004391577
- E-post: dr_mahmoudfaisal@aun.edu.eg
-
Huvudutredare:
- Sara Mansour, lecturer
-
Huvudutredare:
- Ramy Mostafa Abdel Gawad, lecturer
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Placebo-jämförare: 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 |
|
Aktiv komparator: 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 |
|
Aktiv komparator: 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 |
|
Aktiv komparator: 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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of postdural puncture headache
Tidsram: from enrollment to day 15
|
patients suffering from PDPH after drug treatment |
from enrollment to day 15
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Total amount of rescue analgesia
Tidsram: from enrollment to day 15
|
amount of analgesia consumed by patients |
from enrollment to day 15
|
|
Severity of PDPH
Tidsram: from enrollment to day 15
|
using NRS (Numerical Rating Scale). |
from enrollment to day 15
|
|
Intraoperative complications
Tidsram: from enrollment to day 15
|
nausea, vomiting, tremors, sedation, ataxia, dizziness, bradycardia, hypotension, muscle cramps, muscle twitches, bronchoconstriction, miosis, Increased Secretions |
from enrollment to day 15
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- anesth35/26
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