Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000165482
Ethics application status
Approved
Date submitted
14/12/2015
Date registered
10/02/2016
Date last updated
12/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Study comparing headache rates after two different spinal anaesthsia approaches for caeserian section procedure
Scientific title
Post-dural puncture headache after cesarean section: Comparison with median and paramedian approaches
Secondary ID [1] 288151 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post-dural puncture headache 297061 0
complications of spinal anaesthesia for caesarean section 297412 0
Condition category
Condition code
Anaesthesiology 297289 297289 0 0
Other anaesthesiology
Reproductive Health and Childbirth 297597 297597 0 0
Childbirth and postnatal care
Injuries and Accidents 297598 297598 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 293461 0
Treatment: Drugs
Intervention code [2] 293462 0
Prevention
Comparator / control treatment
Median approach group
Control group
Active

Outcomes
Primary outcome [1] 296868 0
Incidence of post-spinal headache will be evaluated. A telephone followup call will use to ask patients if they have a headache. We will use visual analogue scale (0-10). If patients didnt discharged we ask questions in hospital face to face.
Timepoint [1] 296868 0
The patients were questioned for possible occurrence of spinal anesthesia induced headache on the first, third and seventh postoperative days.
Secondary outcome [1] 320153 0
Duration of surgery (assessed by review of hospital records).
Timepoint [1] 320153 0
Total operation time
Secondary outcome [2] 320154 0
Complications associated with spinal anesthesia (Number of hypotensive episodes, total ephedrine and fluid requirements, intraoperative nausea and vomiting and shivering) will assess by review of hospital records.
Timepoint [2] 320154 0
These outcomes will be assessed during the entire operation.

Eligibility
Key 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
Minimum age
19 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/02/2016
Actual
22/02/2016
Date of last participant enrolment
Anticipated
Actual
2/01/2017
Date of last data collection
Anticipated
Actual
9/01/2017
Sample size
Target
200
Accrual to date
Final
200
Recruitment outside Australia
Country [1] 7423 0
Turkey
State/province [1] 7423 0

Funding & Sponsors
Funding source category [1] 292561 0
Hospital
Name [1] 292561 0
Konya Training and Research Hospital
Country [1] 292561 0
Turkey
Primary sponsor type
Hospital
Name
Konya Training and Research Hospital
Address
Konya Training and Research Hospital Clinic of Anesthesiology and Reanimation,Meram Yeniyol Street, 42090,Meram/KONYA
Country
Turkey
Secondary sponsor category [1] 291281 0
None
Name [1] 291281 0
Address [1] 291281 0
Country [1] 291281 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294037 0
Necmettin Erbakan University Meram School of Medicine
Ethics committee address [1] 294037 0
Ethics committee country [1] 294037 0
Turkey
Date submitted for ethics approval [1] 294037 0
21/03/2014
Approval date [1] 294037 0
09/04/2014
Ethics approval number [1] 294037 0
2014/68

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62202 0
Dr Mehmet Selcuk ULUER
Address 62202 0
Konya Training and Research Hospital, Clinic of Anesthesiology and Reanimation, Yeniyol Street Meram/KONYA
Postcode:42090
Country 62202 0
Turkey
Phone 62202 0
+903322212250
Fax 62202 0
Email 62202 0
[email protected]
Contact person for public queries
Name 62203 0
Sadik Ozmen
Address 62203 0
Konya Training and Research Hospital, Clinic of Anesthesiology and Reanimation, Yeniyol StreetMeram/KONYA
Postcode:42090
Country 62203 0
Turkey
Phone 62203 0
+903322212250
Fax 62203 0
Email 62203 0
[email protected]
Contact person for scientific queries
Name 62204 0
Sadik Ozmen
Address 62204 0
Konya Training and Research Hospital, Clinic of Anesthesiology and Reanimation, Yeniyol Street Meram/KONYA
Postcode:42090
Country 62204 0
Turkey
Phone 62204 0
+903322212250
Fax 62204 0
Email 62204 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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