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

Protocol summary

Summary
Aim: Finding the technique, median or paramedian, with least prevalence of post dural puncture headache (PDPH). Design: One centered recruited parturients from Shariati hospital of Bandar Abbas .150 women entered the double -blind randomized (Blocks) study. Divided into two groups of 75 patients, (the median and paramedian groups). Recruitment has finished. 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. Methods: At first a written informed consent was obtained from the patients according to Helsinki declaration. Intrathecal anesthesia applied in sitting position and from the lumbar 4-5 interface with a 25 G, Quincke type needle. Bupivacaine 0.5% (12.5 milligrams) injected intrathecally by an anesthesiologist with the median (first group) or paramedian techniques (second group). The following variables were checked and documented by a researcher unaware of the type of block technique: Primary outcomes were patients' vital signs, the incidence of bradycardia and hypotension, before and at 1, 3, 5 and 10 minutes after spinal block, level of spinal block, nausea and vomiting, amount of ephedrine and atropine usage. Secondary outcomes were post-dural puncture headache (PDPH) on daily checks for 7 days, time to discharge from recovery-out of bed-discharge from hospital.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015060218091N2
Registration date: 2016-09-24, 1395/07/03
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-09-24, 1395/07/03
Registrant information
Name
Fekrat Fereydoon
Name of organization / entity
Hormozgan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 76 3334 4009
Email address
fereydoon.fekrat@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shariati Hospital of Bandar Abbas, Hormozgan University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-03-05, 1394/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two spinal anesthesia approaches: median and paramedian neuraxial blocks on PDPH for cesarean section operations
Public title
Comparing two different styles of needle insertion into the spinal space on the complication of headache after spinal injection of local anesthesia
Purpose
Prevention
Inclusion/Exclusion 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.
Age
From 15 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hormozgan University of Medical Sciences
Street address
Joomhoori Islami Blv., Shahid Mohammadi Hospital,
City
Bandar Abbas
Postal code
7919915519
Approval date
2013-07-22, 1392/04/31
Ethics committee reference number
HEC-92-4-31-1

Health conditions studied

1

Description of health condition studied
Post dural puncture headache after spinal anesthesia
ICD-10 code
G97.1
ICD-10 code description
Other reaction to spinal and lumbar puncture

Primary outcomes

1

Description
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 outcomes

1

Description
Systolic blood pressure
Timepoint
Before and 1, 3, 5, 10 minutes after spinal block
Method of measurement
Non-invasive blood pressure device

2

Description
Diastolic blood pressure
Timepoint
Before and 1, 3, 5, 10 minutes after spinal block
Method of measurement
Non-invasive blood pressure device

3

Description
Heart rate
Timepoint
Before and 1, 3, 5, 10 minutes after spinal block
Method of measurement
Anesthesia electrocardioraphic monitoring equipment

4

Description
level of spinal block
Timepoint
1, 3, 5, 10 minutes after spinal block
Method of measurement
level of sensory block with pinprick test

5

Description
Incidence of nausea and vomiting
Timepoint
During cesarean section and in recovery
Method of measurement
quantitative descriptive

6

Description
Amount of ephedrine usage
Timepoint
During cesarean section
Method of measurement
Quantitative descriptive

7

Description
Amount of atropine usage
Timepoint
During cesarean section
Method of measurement
quantitative descriptive

8

Description
Time to discharge from recovery
Timepoint
Time duration between start of spinal block and discharge from recovery
Method of measurement
Minutes

9

Description
Out of bed time
Timepoint
Time duration between start of spinal block and out of bed time
Method of measurement
Minutes

10

Description
Discharge from hospital
Timepoint
Time duration between start of spinal block and discharge from hospital
Method of measurement
Minutes

Intervention groups

1

Description
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 point type luer-lock hub, Dr. Japan CO. ltd. Tianjin, Hanaco). Bupivacaine 0.5% (12.5 milligram) (Bupivacaine Aguettant sol. Inj. Rachi-anesthesie chloralhydrate hyperbare 20 mg/4 ml, Mylan S.A.S.) injected intrathecally by an anesthesiologist.
Category
Other

2

Description
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 type luer-lock hub, Dr. Japan CO. ltd. Tianjin, Hanaco). Bupivacaine 0.5% (12.5 milligram) (Bupivacaine Aguettant sol. Inj. Rachi-anesthesie chloralhydrate hyperbare 20 mg/4 ml, Mylan S.A.S.) injected intrathecally by an anesthesiologist.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati Hospital of Bandar Abbas
Full name of responsible person
Fereydoon Fekrat
Street address
Hormozgan, Bandar Abbas, Konsoolgari, Bolvar-e-Shahid Naseri
City
Bandar Abbas

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Hormozgan University of Medical Sciences
Full name of responsible person
Abdulazim Nejatizadeh
Street address
Joomhoori Islami Blv., Deputy of Research Center, Shahid Mohammadi Hospital
City
Bandar Abbas
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Hormozgan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Fereydoon Fekrat
Position
Anesthesiology and Intensive care Specialist
Other areas of specialty/work
Street address
Joomhoori Islami Blv., Shahid Mohammadi Hospital
City
Bandar Abbas
Postal code
Phone
+98 76 3334 5009
Fax
Email
fereydoonfekrat@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Anesthesiology, Critical Care and Pain Management Research Center, Hormozgan University of Medical S
Full name of responsible person
Hashem Jarineshin
Position
Assistant Professor of Anesthesiology and Intensive care, Fellowship of Cardiac Surgery Anesthesia
Other areas of specialty/work
Street address
Shahid Mohammadi Hospital, Joomhoori Islami Blvd., Bandar Abbas, Iran
City
Bandar Abbas
Postal code
Phone
+98 76 3334 5009
Fax
Email
hjarineshin@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Anesthesiology, Critical Care and Pain Management Research Center, Hormozgan University of Medical S
Full name of responsible person
Fereydoon Fekrat
Position
Specialist in Anesthesiology and Intensive care
Other areas of specialty/work
Street address
Joomhoori Islami Blv., Shahid Mohammadi Hospital, Bandar Abbas, Iran
City
Bandar Abbas
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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