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The comparison of intravenous dexamethasone and paracetamol in the prevention of post Dural puncture headache in elective cesarean section under spinal anesthesia

Protocol summary

Study aim
The comparison of intravenous dexamethasone and paracetamol in the prevention of post Dural puncture headache in elective cesarean section under spinal anesthesia
Design
Triple blind randomized clinical trial
Settings and conduct
Patients in the first group receive 8 mg dexamethasone in 100 cc normal saline while in the second group patients receive 1000 mg of paracetamol before the spinal anesthesia and patients in the third group received 100 ml of normal saline without preservatives before spinal anesthesia in the microsurgery via micro set and three way in 15 minutes.
Participants/Inclusion and exclusion criteria
Inclusion criteria: ASA I-II Minimum NPO time = 8 hours, Elective cesarean section Exclusion criteria:Contraindications of Spinal anesthesia, Local infection in the lumbar region, Use anti-platelet and anticoagulant, Sensitivity to Local anesthesia, Diabetes mellitus,kidney Diseases, Renal failure, Coagulation disorder, Liver disease, Heart disease, History of seizure or any neurological disease, Migraine and pressure headaches. The history of drug addiction, Failure of spinal anesthesia or multiple attempts to perform spinal anesthesia more than once, Systolic blood pressure above 150 and less than 100, Preeclampsia,IUGR, Weight above 100 ,Height less than 150 and more than 180 cm , Hemoglobin less than 8, Cesarean section more than 3 times, Sensitivity to dexamethasone and paracetamol.
Intervention groups
patients in the first group receive 8 mg dexamethasone in 100 cc normal saline .Patients in the second group receive 1000 mg of paracetamol before the spinal anesthesia in 100 ml of normal saline .Patients in the third group received 100 ml of normal saline without preservatives before spinal anesthesia in the microsurgery via micro set and three way in 15 minutes.
Main outcome variables
Headache,Nausea and Vomiting

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141009019470N80
Registration date: 2019-06-09, 1398/03/19
Registration timing: prospective

Last update: 2019-06-09, 1398/03/19
Update count: 0
Registration date
2019-06-09, 1398/03/19
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-20, 1398/03/30
Expected recruitment end date
2019-08-21, 1398/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of intravenous dexamethasone and paracetamol in the prevention of post Dural puncture headache in elective cesarean section under spinal anesthesia
Public title
The comparison of intravenous dexamethasone and paracetamol in the prevention of post Dural puncture headache in elective cesarean section under spinal anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
ASA I-II Minimum NPO time = 8 hours Elective cesarean section
Exclusion criteria:
Spinal anesthesia Contraindications of Local infection in the lumbar region (spinal cord needle entry site) Use anti-platelet and anticoagulant Sensitivity to Local anesthesia Diabetes mellitus kidney Diseases Renal failure Coagulation disorder Liver disease Heart disease History of seizure or any neurological disease Migraine and pressure headaches The history of drug addiction Failure of spinal anesthesia or multiple attempts to perform spinal anesthesia more than once Systolic blood pressure above 150 and less than 100 Preeclampsia IUGR The lack of proper growth of the uterus Weight above 100 Height less than 150 and more than 180 cm Hemoglobin less than 8 Caesarean section more than 3 times Sensitivity to dexamethasone and paracetamol
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 290
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to one of two groups using the www.Randomizer.org website.
Blinding (investigator's opinion)
Double blinded
Blinding description
All drug solutions of this study will be prepared by the only person who is aware of the study group in similar syringes of the same size and shape and will be provided to anesthetist for injection.Anesthesiologist, patients, and other collaborating staff will be unaware of the design of each patient's study group.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand streetخیابان
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2017-08-23, 1396/06/01
Ethics committee reference number
IR.SUMS.MED.REC.1396.130

Health conditions studied

1

Description of health condition studied
cesarean
ICD-10 code
P03.4
ICD-10 code description
Newborn (suspected to be) affected by Cesarean delivery

Primary outcomes

1

Description
Headache
Timepoint
At the arrival to the recovery room and after discharge from the recovery room at 6,12,24,48,72 hr.
Method of measurement
Visual Analog Score

Secondary outcomes

1

Description
Incidence of Nausea and Vomiting
Timepoint
At the arrival to the recovery room and after discharge from the recovery room at 6,12,24,48,72 hr.
Method of measurement
Observasion

Intervention groups

1

Description
Interventional group: patients in the first group receive 8 mg dexamethasone in 100 cc normal saline via micro set and three way in 15 minutes.
Category
Prevention

2

Description
Intervention group:Patients in the second group receive 1000 mg of paracetamol before the spinal anesthesia in 100 ml of normal saline via micro set and three way in 15 minutes.
Category
Prevention

3

Description
Control group: Patients in the third group received 100 ml of normal saline without preservatives before spinal anesthesia in the microsurgery via micro set and three way in 15 minutes.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Hafez Hospital
Full name of responsible person
Mohammad Hosein Pourjafarian
Street address
Hafez Hospital, Chamran boulevard
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Fax
+98 71 3647 4270
Email
namazi@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemi
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Fax
+98 71 3647 4270
Email
vcrdep@sums.ac
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hosein Pourjafarian
Position
Anesthesiology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
mhpj57@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Elaheh Allahyary
Position
Cardio-Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
allahyary.elaheh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
BS in anesthesia/English Consultant
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Namazi Hospital,Namazi square
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
masihifarzaneh@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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