ClinicalTrials.gg
RecruitingNCT05804448Updated Oct 1, 2026

Effect of Altitude on Postdural Puncture Headache After Caesarean Delivery

An observational study in Post-Dural Puncture Headache, sponsored by B.P. Koirala Institute of Health Sciences. Recruiting at 2 sites in Nepal. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by B.P. Koirala Institute of Health Sciences · Observational

From the registry’s dates

  • Started Apr 2023; still recruiting 3 years 6 months later.
Updated Oct 1, 2026Primary completion movedStudy completion movedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
292
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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

02

Conditions studied

  • Post-Dural Puncture Headache

Keywords

  • Spinal Anesthesia, Cesarean Section
03

In context

Post-Dural Puncture Headache

122 studies on the registry are indexed under Post-Dural Puncture Headache; 27 are open to participants now.

This study's planned enrollment of 292 is above the median of 150 across 35 observational studies indexed under Post-Dural Puncture Headache.

Browse Post-Dural Puncture Headache studies →

Lead sponsor

B.P. Koirala Institute of Health Sciences is the lead sponsor of 54 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Parturient, aged more than or equal to 18 years
  • 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

Exclusion Criteria:

  • Hypertensive disorder
  • Cerebrovascular disease
  • Mental disorder (schizophrenia and other psychotic disorders)
  • Known fetal anomalies
  • 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
292 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to 7 days after spinal anesthesia

Secondary outcomes

  1. 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)

    Time frame: up to 7 days after spinal anesthesia

  2. Number of patients with non-postdural puncture headache

    Headache that is not related to posture

    Time frame: up to 7 days after spinal anesthesia

  3. 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

    Time frame: up to 1 month after occurrence of PDPH

07

Study locations

2 of 2 sites recruiting
  • Karnali Academy of Health Sciences
    Jumla, Karnali 2069, Nepal
    Recruiting
  • BP Koirala Institute of Health Sciences (BPKIHS)
    Dharān, Koshi 56700, Nepal
    Recruiting
08

Updates

1 registry update since Sep 25, 2026
Primary completion
Mar 20, 2026→Dec 20, 2026
Oct 1, 2026
Study completion
Apr 20, 2026→Dec 20, 2026
Oct 1, 2026
Show all 1 update
  1. Oct 1, 2026
    Primary completion Mar 20, 2026→Dec 20, 2026
    Study completion Apr 20, 2026→Dec 20, 2026
    + 2 other changes: verification date and oversight details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT05804448
Lead sponsor
B.P. Koirala Institute of Health Sciences
Collaborators
Karnali Academy of Health Sciences
Responsible party
Dr Asish Subedi (Principal Investigator, B.P. Koirala Institute of Health Sciences) — Principal investigator
First posted
Apr 7, 2023
Start date
Apr 18, 2023
Primary completion
Dec 20, 2026 (estimated)
Completion
Dec 20, 2026 (estimated)
Last update
Oct 1, 2026

Study contacts

Asish Subedi, MD
Contact
ashish.subedi@bpkihs.edu
9842040604

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion