Effect of Altitude on Postdural Puncture Headache After Caesarean Delivery

B.P. Koirala Institute of Health Sciences

Status: Enrolling

Conditions: Post-Dural Puncture Headache

Study type: Observational

Funder types: Other

Identifiers

NCT05804448

533/2022 P

Details and patient eligibility

About

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.

Full 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

Enrollment: 292 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

292 participants in 2 patient groups

High-altitude group

Description:

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

Description:

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.