Effect of Altitude on Postdural Puncture Headache After Caesarean Delivery

B.P. Koirala Institute of Health Sciences292 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

292

Conditions

Post-Dural Puncture Headache

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Karnali Academy of Health Sciences

Jumla, Karnali, Nepal

RECRUITING

BP Koirala Institute of Health Sciences (BPKIHS)

Dharān, Koshi, Nepal

RECRUITING

Outcomes

Primary Outcomes

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

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

Number of patients with non-postdural puncture headache

Headache that is not related to posture

Time frame: 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

Time frame: up to 1 month after occurrence of PDPH

Central Contacts

Asish Subedi, MD

CONTACT

9842040604 ashish.subedi@bpkihs.edu

Data from ClinicalTrials.gov

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