Comparison of median and paramedian approach effet on post-dural puncture headache under spinal anesthesia in the elective cesarean section
Design
In this double-blind clinical trial parallel study (phase 3), 140 pregnant women candidates for cesarean section undergoing spinal anesthesia were included. The patients, by using generated computer numbers, were randomly divided into two groups. In one group the patients underwent intrathecal anesthesia in lumbar intervertebral spaces 4 and 5 with a 25G Quincke needle and 12 mg marcaine 0.5 % by medin method and in another group it was conducted by using the paramedian method.
Settings and conduct
The aim of this study was to compare the post-dural puncture headache in women undergoing cesarean section under spinal anesthesia between the median and paramedian methods. The women candidate for cesarean section in Urmia Shahid Motahari Hospital were enrolled in the study. The patient, the researcher, and the outcome assessor were blinded to placing the patients in the median or paramedian groups.
Participants/Inclusion and exclusion criteria
In this study, pregnant women candidates for elective cesarean section under spinal anesthesia were enrolled. The patients with a history of migraine, an indication for emergency cesarean section, and a previous history of headache after dural puncture were excluded from the study.
Intervention groups
In one group, the patients underwent intrathecal anesthesia in lumbar intervertebral spaces 4 and 5 with a 25G Quincke needle and 12 mg Marcaine 0.5 % by medin method and in another group it was conducted by using the Paramedian method.
Main outcome variables
Post-Dural Puncture Headache
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170516033992N5
Registration date:2020-12-26, 1399/10/06
Registration timing:retrospective
Last update:2020-12-26, 1399/10/06
Update count:0
Registration date
2020-12-26, 1399/10/06
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3222 2010
Email address
karami.t@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-06-19, 1399/03/30
Actual recruitment start date
2020-02-20, 1398/12/01
Actual recruitment end date
2020-06-19, 1399/03/30
Trial completion date
2020-06-19, 1399/03/30
Scientific title
Comparison of median versus paramedian approach effect on post-dural puncture headache under spinal anesthesia in the elective cesarean section
Public title
The effect of median and paramedian approach on post-dural puncture headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women candidate for elective cesarean section
Patients with ASA I and ASA II
Cesarean section by spinal anesthesia
Exclusion criteria:
Patients with a history of migraine
Patients with indication for emergency cesarean section
Patients with previous history of headache after dural-puncture
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
140
Actual sample size reached:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Patients, using random allocation software, were randomly divided into median and paramedian groups. By selecting the simple randomization method in the randomization box and entering the determined total sample size in this software, numbers were given to the patients and the patients were allocated into two groups according to computer-generated numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and the outcome assessor were blinded to the patients' spinal anesthesia approach (anesthetized by median or paramedic approach). An anesthesiologist performed spinal anesthesia in the operating room for randomly selected patients. The patient was only aware that a spinal block was being performed on him, but he was blinded to the needle approach in the median and paramedical method, and the outcome assessor in the later stages was blinded to the type of anesthesia approach (median or paramedian). He only realized that a spinal block had been performed on the patient, but he was blinded to the type of needle approach technique.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences; Resalat street; Jahad Blvd; Urmia; Iran.
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2020-02-10, 1398/11/21
Ethics committee reference number
IR.UMSU.REC.1398.443
Health conditions studied
1
Description of health condition studied
Post-Dural Puncture Headache
ICD-10 code
G44
ICD-10 code description
Other headache syndromes
Primary outcomes
1
Description
Post-Dural Puncture Headache
Timepoint
In recovery room, ward , time of discharge and up to seven days after surgery
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
1
Description
Nausea
Timepoint
Three times after surgery in recovery, ward and discharge time
Method of measurement
Interview with patient
2
Description
Vomiting
Timepoint
Three times after surgery in recovery, ward and discharge time
Method of measurement
Interview with patient
3
Description
Taking Ephedrine (milligram)
Timepoint
Recovery
Method of measurement
Milligram
4
Description
Taking atropine
Timepoint
Recovery room
Method of measurement
Milligram
5
Description
Anesthetic dermatome
Timepoint
Once after surgery
Method of measurement
Clinical examination
Intervention groups
1
Description
Intervention group: group 1: Spinal anesthesia was conducted in the lumbar intervertebral space 4 and 5 with a 25g Quincke needle and 12 mg Marcaine 0.5 % (Marcain® made by Cobel company) by using the median method.
Category
Treatment - Surgery
2
Description
Intervention group: group 2: Spinal anesthesia was conducted in lumbar intervertebral space 4 and 5 with a 25g Quincke needle and 12 mg Marcaine 0.5 % (Marcain® made by Cobel company) by using the paramedian method.