Comparison of post-dural puncture headache after paramedian approach versus Taylors approach
Design
In the present double-blind clinical trial, which will be carried out in a parallel way, a total of 370 patients who will be undergoing elective cesarean section under spinal anesthesia will be enrolled. Eligible Patients will be assigned randomly to tow groups using computer-generated random sequence numbers (www.randomization.org).
Settings and conduct
This study will be done in recovery and ward of Ghadir Mother and Child Hospital in Shiraz. After the intervention, the patients will be assessed in terms of headache by someone unaware of spinal approach on days 1 and 2 once a day and on days 3, 5 and 7 by telephone interview using a questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria: we will study all patients aged 18-44 years with the American Society of Anesthesiologists physical status I/II term pregnant women, who will undergo elective cesarean delivery under spinal anesthesia.
Exclusion criteria: Adult women with ASA grade III or IV, Patients with a history of more than 3 times cesarean section, Hemodynamic instability, Bleeding diathesis or coagulopathy, Chronic headache
Intervention groups
Intervention group P: In the Paramedian approach, patients will be placed in the sitting position and a 27-gauge spinal needle is inserted into the subarachnoid space at an angle of 10-15 degrees in the spaces between L3-4 or L4-5, and then the cephalad is guided.
Intervention group T: Taylor's approach technique will be carried out at the L۵-S۱ inter space, the largest interlaminar inter space of the vertebral column. A 27-gauge spinal needle will be inserted in a cephalo-medial direction through a skin wheel raised ۱ cm medial and ۱ cm caudal to the lowermost prominence of the posterior iliac spine.
Main outcome variables
Postdural puncture headache
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091117002723N2
Registration date:2023-02-07, 1401/11/18
Registration timing:prospective
Last update:2023-02-07, 1401/11/18
Update count:0
Registration date
2023-02-07, 1401/11/18
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
07112337636
Email address
hadavimr@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-01, 1401/12/10
Expected recruitment end date
2023-11-01, 1402/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of post-dural puncture headache after paramedian approach versus Taylor's approach
Public title
Effects of two spinal anesthesia approaches in the Prevalence of headache after operation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Women having elective caesarean section under spinal anesthesia
Women between 18 and 44 years old
Adult women with ASA grade I or II (American Society of Anesthesiology classification)
Exclusion criteria:
Adult women with ASA grade III or IV (American Society of Anesthesiology classification)
Patients with a history of more than 3 times cesarean section
Pregnancy Induced Hypertension
Hemodynamic instability
Bleeding diathesis or coagulopathy
Chronic headache
Patients with local infection in the lumbar region
Age
From 18 years old to 44 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
370
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be assigned randomly to tow groups using computer-generated random sequence numbers (www.randomization.org). Sealed envelopes will be used to conceal the allocation sequence. Group P will include patients who will undergo spinal anesthesia by a cutting 27-gauge spinal needle with a paramedian approach. Group T will include patients who will undergo spinal anesthesia by a cutting 27-gauge spinal needle with Taylor's approach.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants in the study and those who follow up the participants do not know the method of spinal procedure and the specialist performs the spinal anesthesia based on the random sequence table.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz Medical School
Street address
3rd Floor, 3rd buiding of the Shiraz Medical School, Zand Blvd.
City
Shiraz
Province
Fars
Postal code
7134845794
Approval date
2022-12-03, 1401/09/12
Ethics committee reference number
IR.SUMS.REC.1401.587
Health conditions studied
1
Description of health condition studied
Cesarean section
ICD-10 code
O82
ICD-10 code description
Encounter for cesarean delivery without indication
Primary outcomes
1
Description
Headache
Timepoint
Up to 7 days after surgery
Method of measurement
Severity of Postdural puncture headache will be graded by a score described by Lybecker et al
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group P: In the Paramedian approach, patients will be placed in the sitting position and a 27-gauge spinal needle is inserted into the subarachnoid space at an angle of 10-15 degrees in the spaces between L3-4 or L4-5, and then the cephalad is guided.
Category
Prevention
2
Description
Intervention group T: Taylor's approach technique will be carried out at the L۵-S۱ inter space, the largest inter laminar inter space of the vertebral column. A spinal needle will be inserted in a cephalo-medial direction through a skin wheel raised ۱ cm medial and ۱ cm caudal to the lowermost prominence of the posterior iliac spine.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghadir Mother and Child Hospital
Full name of responsible person
Mahsa Tahvili
Street address
Ghadir Mother and Child Hospital, the beginning of Golshan town, above the Quran gate.
City
Shiraz
Province
Fars
Postal code
۷۱۴۴۹۹۵۳۷۷
Phone
+98 71 3227 9701
Fax
Email
Motherhosp@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Mahtab Memarpoor
Street address
7th floor, central building of Shiraz University of Medical Sciences, Vice Chancellor of research, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 7282
Fax
+98 71 3212 2430
Email
memarpour@sums.ac.ir
Web page address
https://rde.sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?