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Effect of Altitude on Postdural Puncture Headache After Caesarean Delivery

Effect of Altitude on Postdural Puncture Headache After Caesarean Delivery: a Prospective, Multicentre Cohort Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05804448
Enrollment
292
Registered
2023-04-07
Start date
2023-04-18
Completion date
2026-04-20
Last updated
2025-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Dural Puncture Headache

Keywords

Spinal Anesthesia, Cesarean Section

Brief summary

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.

Detailed description

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

Interventions

None listed

Sponsors

Karnali Academy of Health Sciences
CollaboratorOTHER
B.P. Koirala Institute of Health Sciences
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum

Inclusion criteria

* Parturient, aged more than or equal to 18 years * American society of Anesthesiologist 2 and 3 * Scheduled for elective and non-elective (category 2 & 3) caesarean delivery with spinal anesthesia * Native to their resident altitude i.e., those born, raised, and have continuously lived at the same altitude, at least for the past 1 year.

Exclusion criteria

* Hypertensive disorder * Cerebrovascular disease * Mental disorder (schizophrenia and other psychotic disorders) * Known fetal anomalies * Contraindication to spinal anaesthesia. * Those requiring general anaesthesia for delivery due to failed spinal anesthesia * Major post-delivery complications (severe haemorrhage, sepsis, or ICU admission) * Those who migrate from their resident altitude (either low to high or vice versa) within 7 days post-delivery will also be excluded.

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with postdural puncture headacheup to 7 days after spinal anesthesiaThe 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.

Secondary

MeasureTime frameDescription
Number of patients with severity of postdural puncture headacheup to 7 days after spinal anesthesiausing 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)
Number of patients with non-postdural puncture headacheup to 7 days after spinal anesthesiaHeadache that is not related to posture
Number of patients who received treatment for postdural puncture headacheup to 1 month after occurrence of PDPHparacetamol, NSAID's, caffeine, opioids, glossopharyngeal nerve block, sphenopalatine ganglion block and epidural blood patch

Countries

Nepal

Contacts

Primary ContactAsish Subedi, MD
ashish.subedi@bpkihs.edu9842040604

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026