Effect of Altitude on Postdural Puncture Headache After Caesarean Delivery
- Conditions
- Post-Dural Puncture Headache
- Registration Number
- NCT05804448
- Lead Sponsor
- B.P. Koirala Institute of Health Sciences
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 292
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of patients with postdural puncture headache 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.
- Secondary Outcome Measures
Name Time Method Number of patients with severity of postdural puncture headache up to 7 days after spinal anesthesia 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)
Number of patients with non-postdural puncture headache up to 7 days after spinal anesthesia Headache that is not related to posture
Number of patients who received treatment for postdural puncture headache up to 1 month after occurrence of PDPH paracetamol, NSAID's, caffeine, opioids, glossopharyngeal nerve block, sphenopalatine ganglion block and epidural blood patch
Trial Locations
- Locations (2)
Karnali Academy of Health Sciences
🇳🇵Jumla, Karnali, Nepal
BP Koirala Institute of Health Sciences (BPKIHS)
🇳🇵Dharān, Koshi, Nepal
Karnali Academy of Health Sciences🇳🇵Jumla, Karnali, NepalRobin Khapung, MDContact9849481562robinkhapung@hotmaail.com