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Postdural puncture headache and normal saline

Injection of intratechal normal saline in decreasing postdural puncture headache (PDPH)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT138803051951N1
Enrollment
100
Registered
2011-05-08
Start date
2009-04-01
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal anesthesia. Spinal and epidural anaesthesia-induced headache during pregnancy

Interventions

Intervention 1: After obtaining free-flowing cerebrospinal fluid, the injection of 5mL intrathecal normal saline and then injection of 2.5 mL (12.5 mg) hyperbaric bupivacaine was performed in group S
Prevention
After obtaining free-flowing cerebrospinal fluid, the injection of 5mL intrathecal normal saline and then injection of 2.5 mL (12.5 mg) hyperbaric bupivacaine was performed in group S as a study group
After obtaining free-flowing cerebrospinal fluid, 2.5 ml (12.5 mg) hyperbaric bupivacaine was injected in group C as a control group.

Sponsors

Tehran University of Medical scinces/Vice chancellor for research
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: healthy women (ASA physical status I) with ages between 18-35 years scheduled for elective term cesarean delivery under spinal anesthesia. Exclusion criteria: Parturient were excluded from the study if they had preexisting hypertension, diabetes mellitus, chronic headache, history of previous PDPH, number of lumbar puncture attempts more than two and contraindication to spinal anesthesia.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Existence of headache and severity. Timepoint: 12, 24 and 48 hours and 3 rd and 7th days after cesarean section. Method of measurement: interview.

Secondary

MeasureTime frame
Complications. Timepoint: any time. Method of measurement: asking patients.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Nasrin Faridi Tazeh-kand

Tehran University of Medical Sciences

nfaridi@sina.tums.ac.ir+98 21 7788 3283

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026