Post-Dural Puncture HeadacheNCT05804448
Effect of Altitude on Postdural Puncture Headache After Caesarean Delivery
An observational study of Post-Dural Puncture Headache, run by B.P. Koirala Institute of Health Sciences at 2 sites in Nepal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post-Dural Puncture Headache
- How many people
- 292 participants
- Where
- 2 sitesNepal
- Study dates
- 18 Apr 2023to 20 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: Parturients planned for elective and non-elective (category 2 \& 3) caesarean section under spinal anaesthesia.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Nepal2 sites, 2 recruiting
- Recruiting
BP Koirala Institute of Health Sciences (BPKIHS)
Dharān, Koshi, 56700
Asish Subedi, MD, 977-25-525555 ext. 2013, ashish.subedi@bpkihs.edu
Asish Subedi, MD
- Recruiting
Karnali Academy of Health Sciences
Jumla, Karnali, 2069
Robin Khapung, MD, 9849481562, robinkhapung@hotmaail.com
About this study
Official title: 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.
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
- Conditions
- Post-Dural Puncture Headache
- Keywords
- Spinal Anesthesia, Cesarean Section
- Medical subject headings
- Post-Dural Puncture Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 7 days after spinal anesthesia
Secondary outcomes (3)
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)
Measured: up to 7 days after spinal anesthesia
Number of patients with non-postdural puncture headache
Headache that is not related to posture
Measured: 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
Measured: up to 1 month after occurrence of PDPH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start18 Apr 2023
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Dural Puncture HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 292 participants (estimated)
Sponsor and investigators
- Lead sponsor
- B.P. Koirala Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Karnali Academy of Health Sciences
- Responsible party
- Principal investigator, Dr Asish Subedi, B.P. Koirala Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804448
- Sponsor's protocol ID
- 533/2022 P
- Status last verified
- Sep 2026
- First submitted
- 27 Mar 2023
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Altitude on Postdural Puncture Headache After Caesarean Delivery: a Prospective, Multicentre Cohort Study
- ClinicalTrials.gov ID
- NCT05804448
- Acronym / sponsor ID
- 533/2022 P
- Conditions
- Post-Dural Puncture Headache
- Keywords
- Spinal Anesthesia, Cesarean Section
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 292 participants (estimated)
- Lead sponsor
- B.P. Koirala Institute of Health SciencesUniversity, hospital or other
- Collaborators
- Karnali Academy of Health Sciences
- Study start
- 18 Apr 2023 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Parturients planned for elective and non-elective (category 2 \& 3) caesarean section under spinal anaesthesia.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- Hypertensive disorder
- Cerebrovascular disease
- Mental disorder (schizophrenia and other psychotic disorders)
- Known fetal anomalies
- Contraindication to spinal anaesthesia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Number of patients with severity of postdural puncture headache
Time frame: up to 7 days after spinal anesthesia
Number of patients with non-postdural puncture headache
Time frame: up to 7 days after spinal anesthesia
Number of patients who received treatment for postdural puncture headache
Time frame: up to 1 month after occurrence of PDPH
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Dural Puncture Headache, run by B.P. Koirala Institute of Health Sciences at 2 sites in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asish Subedi, MD (9842040604, ashish.subedi@bpkihs.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with postdural puncture headache (time frame: up to 7 days after spinal anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.