Clinical trial NCT05804448: Effect of Altitude on Postdural Puncture Headache After Caesarean Delivery
Official title: Effect of Altitude on Postdural Puncture Headache After Caesarean Delivery: a Prospective, Multicentre Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post-Dural Puncture Headache
Keywords: Spinal Anesthesia, Cesarean Section
Lead sponsor: B.P. Koirala Institute of Health Sciences
Sponsor class: OTHER
Collaborators: name: Karnali Academy of Health Sciences
First posted: 2023-04-07
Enrollment: 292
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parturients planned for elective and non-elective (category 2 \& 3) caesarean section under spinal anaesthesia.

Brief 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients with postdural puncture headache
timeFrame: up to 7 days after spinal anesthesia
Secondary outcomes:
measure: Number of patients with severity of postdural puncture headache
timeFrame: up to 7 days after spinal anesthesia
measure: Pain assessed by PROMIS pain interference scale
timeFrame: 7 days after occurrence of postdural puncture headache
measure: Number of patients with non-postdural puncture headache
timeFrame: up to 7 days after spinal anesthesia
measure: Number of patients who received treatment for postdural puncture headache
timeFrame: up to 1 month after occurrence of PDPH
measure: Number of patient with chronic headache
timeFrame: At 1 and 3 months after occurrence of headache following spinal anesthesia
measure: Number of patients with chronic backache
timeFrame: At 1 and 3 months after spinal anesthesia
measure: Number of patients with chronic post surgical pain
timeFrame: 3 month after caesarean section
Other outcomes:
Locations:
city: Jumla
country: Nepal
facility: Karnali Academy of Health Sciences
state: Karnali
city: Dharān Bāzār
country: Nepal
facility: BP Koirala Institute of Health Sciences (BPKIHS)
state: Koshi
Study officials:
References: