Effect of Altitude on Postdural Puncture Headache After Caesarean Delivery

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorB.P. Koirala Institute of Health Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Hypertensive disorder

Cerebrovascular disease

Mental disorder (schizophrenia and other psychotic disorders)

Known fetal anomalies

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

292 Participants
are grouped into 2 trial groups
Group A: High-altitude group
Group B: Low-altitude group

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

B.P. Koirala Institute of Health Sciences

Lead sponsor

Karnali Academy of Health Sciences

Collaborator