Predictive Value of ONSD and NIRS for PDPH
NCT07729449
Brain Diseases, Cardiovascular Diseases
Ordu, Altinordu, Turkey (Türkiye)
View Trial DetailsNCT Number: NCT05804448
The aim of this study is to examine the effects of altitude (high altitude versus low altitude) on incidence and severity of postural puncture headache (PDPH) following spinal anaesthesia for caesarean delivery. The investigators hypothesized that the risk of PDPH would be higher in highlander parturients than in lowlander parturients.
Interested in participating?
Request Info18 year and older
Female
Observational
Karnali Academy of Health Sciences, Jumla, Karnali, Nepal
This will be a prospective cohort study conducted in two different altitudes in Nepal. The high-altitude site is in Jumla, approximately 2514 m above the sea level, and a low altitude city is Dharan, located at 350 m from sea level.
The investigators will screen the eligible participant admitted to the in-patient obstetric unit. The investigator will also record patient baseline characteristics, preoperative anxiety, antenatal depression, presence of chronic pain conditions or preexisting headache. Spinal anaesthesia will be administered in the sitting position at the L3-L4 or L4-L5 interspace using a 25-G pencil point spinal needle (Pencan® 25-gauge).
The diagnosis of post-dural puncture headache will be based on the international headache society ICDH-3 criteria
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: up to 7 days after spinal anesthesia
The diagnosis of post-dural puncture headache will be based on the international headache society ICDH-3 criteria: a headache that occurs within 5 days of a dural puncture, is located in the occipital and/or frontal areas, worsens within 15 min of sitting or standing and alleviates within 15 min after lying down, associated with at least one of the following features: neck stiffness, nausea, vomiting, photophobia, and tinnitus, and resolves either spontaneously within 1 week or within 48 h after effective treatment.
Time frame: up to 7 days after spinal anesthesia
using a numeric rating scale (NRS), with 0= NO pain 10=worst imaginable pain, and classified as none (NRS=0), mild (1-3), moderate (4-6), and severe (7-10)
Time frame: up to 7 days after spinal anesthesia
Headache that is not related to posture
Time frame: up to 1 month after occurrence of PDPH
paracetamol, NSAID's, caffeine, opioids, glossopharyngeal nerve block, sphenopalatine ganglion block and epidural blood patch
Contact information is provided by the study sponsor or research team.
B.P. Koirala Institute of Health Sciences
Other
Effect of Altitude on Postdural Puncture Headache After Caesarean Delivery: a Prospective, Multicentre Cohort Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07729449
Brain Diseases, Cardiovascular Diseases
Ordu, Altinordu, Turkey (Türkiye)
View Trial DetailsNCT06824025
Brain Diseases, Central Nervous System Diseases
Minya, Egypt
View Trial DetailsNCT07515456
Brain Diseases, Central Nervous System Diseases
Tanta, El-Gharbia, Egypt
View Trial DetailsNCT05116930
Brain Diseases, Central Nervous System Diseases
Rochester, Minnesota, United States
View Trial Details