1) Objectives: Postdural puncture headache (PDPH) is a common complication associated with spinal anesthesia. Considering the higher incidence of PDPH in pregnancy and the controversies of the results of previous studies, we decided to compare the incidence of PDPH after spinal anesthesia using Midline & Para-median approaches in cesarean section.
2) Design: After obtaining informed consent patients will be studied in two groups (N=55 in each group). Spinal anesthesia will be performed in all patients in sitting position with 25 gauge Quincke needle in L3-L4 or L4-L5 inter space using 10 mg hyperbaric bupivacaine plus 2.5 micro gram sufentanil. Spinal block will be performed using midline in one study group and paramedian approach in another group of patients. 3) Setting & conduct: Patients will be studied in first, second and third day after operation and the occurrence of headache and backache will be recorded. Severity of pain will be assessed by Visual Analogue Scale of pain (1-10). The patients and the nurse who recorded the vital signs and symptoms like headache and backache are not aware of the grouping. Spinal block will be performed by one anesthesiologist in all patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201707028768N6
Registration date:2017-08-18, 1396/05/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-18, 1396/05/27
Registrant information
Name
Mahshid Nikooseresht
Name of organization / entity
Hamadan university of Medical Sciences, Faculty of Medicine
Country
Iran (Islamic Republic of)
Phone
+98 81 3823 5383
Email address
nikooseresht@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research and Technology, Hamadan University Of Medical Sciences
Expected recruitment start date
2017-09-01, 1396/06/10
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the incidence of post spinal puncture headache between
midline and paramedian approaches after cesarean section.
Public title
comparison of post dural puncture headache in midline and paramedian approaches
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All of the ASA 1 healthy term parturients (15-45 yr) referring to Fatemieh hospital candidate for Cesarean section were included in the study.
Exclusion criteria: chronic hypertension; pre eclampsia; more than one attempt for spinal block; insufficient spinal block that needs more analgesia; allergy to drugs; history of migraine or chronic headache; patients receiving psychiatric drugs
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
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
Committee of Ethics in Research, Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Science, Shahid Fahmideh street, Hamadan
City
Hamadan
Postal code
Approval date
2017-06-17, 1396/03/27
Ethics committee reference number
IR.UMSHA.REC.1396.255
Health conditions studied
1
Description of health condition studied
post dural puncture headache
ICD-10 code
O74.5
ICD-10 code description
Spinal and epidural anaesthesia-induced headache during labour and delivery
Primary outcomes
1
Description
post spinal headache
Timepoint
first؛ second and third day after surgery
Method of measurement
interview with VAS measurement
Secondary outcomes
1
Description
Backache
Timepoint
at first؛ second and third day after surgery
Method of measurement
Interview with VAS
2
Description
Hypotension
Timepoint
every 2 minutes until delivery and then every 10 minutes
Method of measurement
BP measurement with automatic blood pressure device
Intervention groups
1
Description
Intervention 1: In sitting position using Quincke 25 Gauge needle with bevel parallel to sagital plane from L3-L4 or L4-L5 space with midline approach spinal injection will be performed with 10 mg hyperbaric bupivacaine plus 2.5 microgram sufentanil.
Category
Treatment - Drugs
2
Description
intervention2: In sitting position using Quincke 25 Gauge needle with bevel parallel to sagital plane from L3-L4 or L4-L5 space with paramedian approach spinal injection will be performed with 10 mg hyperbaric bupivacaine plus 2.5 microgram sufentanil. In paramedian approach spinal needle was inserted from point 1 cm lateral and 1cm inferior to the superior spinous process of the upper vertebrae with 10-15 angulation toward the midline.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh hospital
Full name of responsible person
Mahshid Nikooseresht
Street address
Pasdaran Street, Shariati square, Hamadan, Iran
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research and Technology, Hamadan University Of Medical Sciences
Full name of responsible person
Saiid Bashirian
Street address
Hamadan University of Medical Science, Shahid Fahmideh street, Hamadan
City
Hamadan
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 and Technology, Hamadan 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
Hamadan University of Medical Sciences
Full name of responsible person
Mahshid Nikooseresht M.D
Position
Associate Professor of Anesthsiology, Fellowship of Pain managenent