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NCT Number: NCT05804448

Effect of Altitude on Postdural Puncture Headache After Caesarean Delivery

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Karnali Academy of Health Sciences, Jumla, Karnali, Nepal

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About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of patients with postdural puncture headache

    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.

Secondary outcomes

  1. Number of patients with severity of postdural puncture headache

    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)

  2. Number of patients with non-postdural puncture headache

    Time frame: up to 7 days after spinal anesthesia

    Headache that is not related to posture

  3. Number of patients who received treatment for postdural puncture headache

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Asish Subedi, MD

CONTACT

[email protected]

9842040604

Sponsors and collaborators

Lead sponsor

B.P. Koirala Institute of Health Sciences

Other

Collaborators

  • Karnali Academy of Health Sciences

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 7, 2023
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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.

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