Effect of Altitude on Postdural Puncture Headache After Caesarean Delivery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| High-altitude group 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. |
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| Low-altitude group 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. |
Outcome Measures
Primary Outcome Measures
- 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
- 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)
- Pain assessed by PROMIS pain interference scale [7 days after occurrence of postdural puncture headache]
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
- 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
- Number of patient with chronic headache [At 1 and 3 months after occurrence of headache following spinal anesthesia]
Headache that is persistent after postdural puncture headache or after non-postdural puncture headache
- Number of patients with chronic backache [At 1 and 3 months after spinal anesthesia]
Presence of backache after spinal anesthesia
- Number of patients with chronic post surgical pain [3 month after caesarean section]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Parturient, aged more than or equal to 18 years
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American society of Anesthesiologist 2 and 3
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Scheduled for elective and non-elective (category 2 & 3) caesarean delivery with spinal anesthesia
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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:
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Hypertensive disorder
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Cerebrovascular disease
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Mental disorder (schizophrenia and other psychotic disorders)
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Known fetal anomalies
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Contraindication to spinal anaesthesia.
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Those requiring general anaesthesia for delivery due to failed spinal anesthesia
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Major post-delivery complications (severe haemorrhage, sepsis, or ICU admission)
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Those who migrate from their resident altitude (either low to high or vice versa) within 7 days post-delivery will also be excluded.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Karnali Academy of Health Sciences | Jumla | Karnali | Nepal | 2069 |
| 2 | BP Koirala Institute of Health Sciences (BPKIHS) | Dharān Bāzār | Koshi | Nepal | 56700 |
Sponsors and Collaborators
- B.P. Koirala Institute of Health Sciences
- Karnali Academy of Health Sciences
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 533/2022 P