Comparing two different styles of needle insertion into the spinal space on the complication of headache after spinal injection of local anesthesia

Comparison of two spinal anesthesia approaches: median and paramedian neuraxial blocks on PDPH for cesarean section operations

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015060218091N2

Enrollment

150

Registered

2016-09-24

Start date

2015-08-23

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

Post dural puncture headache after spinal anesthesia. Other reaction to spinal and lumbar puncture

Interventions

Intervention 1: Intrathecal anesthesia with the paramedian technique group: will be applied in sitting position and from the lumbar 4-5 interface with a 25 G, Quincke type needle (Dr. J disposable spi

Intrathecal anesthesia with the paramedian technique group: will be applied in sitting position and from the lumbar 4-5 interface with a 25 G, Quincke type needle (Dr. J disposable spinal needle K-3 p

Intrathecal anesthesia with the median technique group: will be applied in sitting position and from the lumbar 4-5 interface with a 25 G, Quincke type needle (Dr. J disposable spinal needle K-3 point

Eligibility

Sex/Gender

Female

Age

15 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 15-45 years old, elective cesarean section. Exclusion criteria: ASA III-IV, more than one dural puncture, previous PDPH, contraindication for spinal anesthesia, block failure, surgical complications, patients who did not complete the 7 days follow up period.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Post- dural puncture headache. Timepoint: on daily checks for 7 days. Method of measurement: according to the definition from the International Pain Association, (A headache that occurs in the back of the head or forehead area for a duration of less than 7 days is called post-dural puncture headache).	—

Secondary

Measure	Time frame
Systolic blood pressure. Timepoint: Before and 1, 3, 5, 10 minutes after spinal block. Method of measurement: Non-invasive blood pressure device.;Diastolic blood pressure. Timepoint: Before and 1, 3, 5, 10 minutes after spinal block. Method of measurement: Non-invasive blood pressure device.;Heart rate. Timepoint: Before and 1, 3, 5, 10 minutes after spinal block. Method of measurement: Anesthesia electrocardioraphic monitoring equipment.;Level of spinal block. Timepoint: 1, 3, 5, 10 minutes after spinal block. Method of measurement: level of sensory block with pinprick test.;Incidence of nausea and vomiting. Timepoint: During cesarean section and in recovery. Method of measurement: quantitative descriptive.;Amount of ephedrine usage. Timepoint: During cesarean section. Method of measurement: Quantitative descriptive.;Amount of atropine usage. Timepoint: During cesarean section. Method of measurement: quantitative descriptive.;Time to discharge from recovery. Timepoint: Time duration between start of spinal block and discharge from recovery. Method of measurement: Minutes.;Out of bed time. Timepoint: Time duration between start of spinal block and out of bed time. Method of measurement: Minutes.;Discharge from hospital. Timepoint: Time duration between start of spinal block and discharge from hospital. Method of measurement: Minutes.	—

Measure

Time frame

Systolic blood pressure. Timepoint: Before and 1, 3, 5, 10 minutes after spinal block. Method of measurement: Non-invasive blood pressure device.;Diastolic blood pressure. Timepoint: Before and 1, 3, 5, 10 minutes after spinal block. Method of measurement: Non-invasive blood pressure device.;Heart rate. Timepoint: Before and 1, 3, 5, 10 minutes after spinal block. Method of measurement: Anesthesia electrocardioraphic monitoring equipment.;Level of spinal block. Timepoint: 1, 3, 5, 10 minutes after spinal block. Method of measurement: level of sensory block with pinprick test.;Incidence of nausea and vomiting. Timepoint: During cesarean section and in recovery. Method of measurement: quantitative descriptive.;Amount of ephedrine usage. Timepoint: During cesarean section. Method of measurement: Quantitative descriptive.;Amount of atropine usage. Timepoint: During cesarean section. Method of measurement: quantitative descriptive.;Time to discharge from recovery. Timepoint: Time duration between start of spinal block and discharge from recovery. Method of measurement: Minutes.;Out of bed time. Timepoint: Time duration between start of spinal block and out of bed time. Method of measurement: Minutes.;Discharge from hospital. Timepoint: Time duration between start of spinal block and discharge from hospital. Method of measurement: Minutes.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFereydoon Fekrat

Hormozgan University of Medical Sciences

fereydoonfekrat@yahoo.com+98 76 3334 5009

Outcome results

None listed

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