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

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.

Study Overview

• Status: Recruiting
• Conditions: Post-Dural Puncture Headache

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

• Study Type: Observational
• Enrollment (Estimated): 292

Contacts and Locations

• Study Contact: Name: Asish Subedi, MD; Phone Number: 9842040604; Email: ashish.subedi@bpkihs.edu

Study Locations

• Nepal
  • Karnali
    • Jumla, Karnali, Nepal, 2069
      • Recruiting
      • Karnali Academy of Health Sciences
      • Contact: Robin Khapung, MD; Phone Number: 9849481562; Email: robinkhapung@hotmaail.com
  • Koshi
    • Dharān, Koshi, Nepal, 56700
      • Recruiting
      • BP Koirala Institute of Health Sciences (BPKIHS)
      • Contact: Asish Subedi, MD; Phone Number: 2013 977-25-525555; Email: ashish.subedi@bpkihs.edu
      • Principal Investigator: Asish Subedi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Parturients planned for elective and non-elective (category 2 & 3) caesarean section under spinal anaesthesia.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
High-altitude group; Parturient who are native to their resident altitude, i.e. residing at the altitude above 2500 m from sea level will receive spinal anesthesia for caesarean section.
Low-altitude group; Parturient who are native to their resident altitude, i.e. residing at the altitude below 500 m from sea level will receive spinal anesthesia for caesarean section.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with postdural puncture headache	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.	up to 7 days after spinal anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with severity of postdural puncture headache	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)	up to 7 days after spinal anesthesia
Number of patients with non-postdural puncture headache	Headache that is not related to posture	up to 7 days after spinal anesthesia
Number of patients who received treatment for postdural puncture headache	paracetamol, NSAID's, caffeine, opioids, glossopharyngeal nerve block, sphenopalatine ganglion block and epidural blood patch	up to 1 month after occurrence of PDPH

Collaborators and Investigators

• Sponsor: B.P. Koirala Institute of Health Sciences
• Collaborators: Karnali Academy of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2023
• Primary Completion (Estimated): March 20, 2026
• Study Completion (Estimated): April 20, 2026

Study Registration Dates

• First Submitted: March 27, 2023
• First Submitted That Met QC Criteria: April 6, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Spinal Anesthesia, Cesarean Section
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders; Headache Disorders, Secondary; Post-Dural Puncture Headache
• Other Study ID Numbers: 533/2022 P

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No