Effect of Altitude on Postdural Puncture Headache After Caesarean Delivery

Post-Dural Puncture Headache Clinical Trial

Official title:

Effect of Altitude on Postdural Puncture Headache After Caesarean Delivery: a Prospective, Multicentre Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05804448
• Other study ID #: 533/2022 P
• Status: Recruiting
• Start date: April 18, 2023
• Est. completion date: April 20, 2025

Study information

• Verified date: April 2023
• Source: B.P. Koirala Institute of Health Sciences
• Contact: Asish Subedi, MD
• Phone: 9842040604
• Email: ashish.subedi[@]bpkihs.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 292
• Est. completion date: April 20, 2025
• Est. primary completion date: January 20, 2025
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Post-Dural Puncture Headache

Locations

Country	Name	City	State
Nepal	BP Koirala Institute of Health Sciences (BPKIHS)	Dharan Bazar	Koshi
Nepal	Karnali Academy of Health Sciences	Jumla	Karnali

Sponsors (2)

Lead Sponsor	Collaborator
B.P. Koirala Institute of Health Sciences	Karnali Academy of Health Sciences

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 7 days after spinal anesthesia
Secondary	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)	up to 7 days after spinal anesthesia
Secondary	Pain assessed by PROMIS pain interference scale	6-item PROMIS Pain Interference short form scale will be used to assess the self-reported consequences of PDPH on social, cognitive, physical, and recreational activities. Respondents will be asked to rate the interference of pain in each activity listed using a 1 to 5 scale, where 1 = Not at all. 2 = A little bit, 3 = Somewhat, 4 = Quite a bit, and 5 = Very much	7 days after occurrence of postdural puncture headache
Secondary	Number of patients with non-postdural puncture headache	Headache that is not related to posture	up to 7 days after spinal anesthesia
Secondary	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	up to 1 month after occurrence of PDPH
Secondary	Number of patient with chronic headache	Headache that is persistent after postdural puncture headache or after non-postdural puncture headache	At 1 and 3 months after occurrence of headache following spinal anesthesia
Secondary	Number of patients with chronic backache	Presence of backache after spinal anesthesia	At 1 and 3 months after spinal anesthesia
Secondary	Number of patients with chronic post surgical pain	Pain that develops or increases in intensity after cesarean section and persists at least 3 months after the surgery. The pain has to be localised to the surgical field or area of injury. Other causes of pain such as pre-existing pain conditions or infections, or malignancy etc. have to be excluded.	3 month after caesarean section