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Study comparing headache rates after two different spinal anaesthsia approaches for caeserian section procedure

Post-dural puncture headache after cesarean section: Comparison with median and paramedian approaches

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000165482
Enrollment
200
Registered
2016-02-10
Start date
2016-02-22
Completion date
2017-01-02
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

This study aims to evaluated the comparison with median and paramedian approaches on PDPH after cesarean section.For this study 200 pregnant scheduled to undergo elective caesarean section under spinal anesthesia, will study. To evaluate the PDPH the patients will be questioned for possible occurrence of spinal anesthesia induced headache on the first, third and seventh postoperative days.

Interventions

Two hundred pregnant, gestational age 38-40, between the ages of 19-45 yr, ASA physical status I, scheduled to undergo elective caesarean section under spinal anesthesia, will study. All patients were expected to fast 6-8 hours before CS, and no one will premedicate. Routine monitors (consisting of a pulse oximeter, 3-lead ECG and a non-invasive blood pressure cuff) will apply. Baseline measurements will obtaine while patients were supin position. Following prehydration with Ringer’s lactate sol

Two hundred pregnant, gestational age 38-40, between the ages of 19-45 yr, ASA physical status I, scheduled to undergo elective caesarean section under spinal anesthesia, will study. All patients were expected to fast 6-8 hours before CS, and no one will premedicate. Routine monitors (consisting of a pulse oximeter, 3-lead ECG and a non-invasive blood pressure cuff) will apply. Baseline measurements will obtaine while patients were supin position. Following prehydration with Ringer’s lactate solution 10 ml/kg, spinal anesthesia will induce with hyperbaric bupivacaine 10-12.5 mg via a 25 G Quincke-tip spinal needle in the sitting position at the L4-5 vertebral level using a median (Group M) or paramedian (Group PM) approach by an anesthesiologist with more then 8 years experience (MSU). The patients will randomize, by using a computer-generated block randomisation, into 2 groups: Group M (n=100) median approach, Group PM (n=100) paramedian approach. Patients will then positione in a 10 degrees left-lateral tilt. Oxygen (4 l.min-1) will administere through a facemask. Surgery will initiate when the sensory block level reached at T4. Systolic (SBP), diastolic (DBP),mean (MBP) blood pressure, heart rate (HR), oxygen saturation (SpO2) values will continuously record (basal, after spinal anesthesia, at the start of surgery, every 5 minutes during surgery, at the end of surgery). Hypotension will define as a decrease in SBP of higher than 30 percent below baseline or to less than 90 mmHg and will treate by increasing the rate of crystalloid infusion. If hypotension persiste a bolus of iv ephedrine 5 mg will given. Bradycardia will define as HR less than 60 beats/min and was treated with iv atropine 0.5 mg. Patiens demografic data (age, weight, height, gestation, gravidity), duration of surgery, number of hypotensive episodes, total ephedrine and fluid requirements, intraoperative nausea and vomiting and shivering will also note. The patients will questione for possible occurrence of spinal anesthesia induced headache on the first, third and seventh postoperative days. A telephone followup call will use if the hospital stay is shorter than 7 days. Post dural puncture headache evaluations will performe by a different anesthesiologist blinded to the study.

Sponsors

Konya Training and Research Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
19 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

Two hundred pregnant, gestational age 38-40, between the ages of 19-45 yr, ASA physical status I, scheduled to undergo elective caesarean section under spinal anesthesia, were studied

Exclusion criteria

Exclusion criteria were contraindication to neuraxial anesthesia or known allergy to bupivacaine, spinal puncture failure, or a need for additional intraoperative analgesia, body mass index (BMI) >35 kg/m2, general anesthesia or epidural anesthesia, emergency CS and patients with chronic or postdural puncture headache history.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026