Comparison of 10 and 12 mg doses of intrathecal bupivacaine %0.5 on sensory block level and postdural puncture headache in patients under repeated spinal after failed spinal anesthesia in C/S.
Comparison of 10 and 12 mg doses of intrathecal bupivacaine %0.5 on sensory block level and postdural puncture headache in patients under repeated spinal after failed spinal anesthesia in Cesarean Section
Design
In this double-blind study, 40 patients aged 18-46 years old with a cesarean section at Fatemiyeh Hospital of Hamadan were enrolled in the study after obtaining informed consent
Settings and conduct
The study will be conducted at Fatemieh Hospital in Hamadan.Patients will be randomly divided into two groupsو In group A, patients undergoing spinal anesthesia with 10 mg bupivacaine 0.5 % and in group B, they undergo spinal anesthesia with 12 mg bupivacaine 0.5%.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patient's consent to participate in the study; No history for diabetes, high blood pressure, heart disease; Patients who have failed spinal anesthesia and undergo general anesthesia.
Exclusion criteria:Patients with contraindications of spinal anesthesia (ICP increase, shock, history of coagulation problems ..).
Intervention groups
In group A, patients undergoing spinal anesthesia with 10 mg bupivacaine 0.5 % and in group B, they undergo spinal anesthesia with 12 mg bupivacaine 0.5%.
Main outcome variables
sensory block, Headache
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120915010841N20
Registration date:2019-09-06, 1398/06/15
Registration timing:retrospective
Last update:2019-09-06, 1398/06/15
Update count:0
Registration date
2019-09-06, 1398/06/15
Registrant information
Name
Nahid Manuchehrian
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 7012
Email address
manouchehrian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-23, 1397/04/02
Expected recruitment end date
2019-06-23, 1398/04/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of 10 and 12 mg doses of intrathecal bupivacaine %0.5 on sensory block level and postdural puncture headache in patients under repeated spinal after failed spinal anesthesia in C/S.
Public title
Comparison of 10 and 12 mg doses of intrathecal bupivacaine %0.5 on sensory block level and postdural puncture headache in patients under repeated spinal
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Patient's consent to participate in the study
No history for diabetes, high blood pressure, heart disease
Patients who have failed spinal anesthesia and undergo general anesthesia
Exclusion criteria:
Patients with contraindications of spinal anesthesia (ICP increase, shock, history of coagulation problems ..)
Age
From 18 years old to 48 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In this study , a randomized block design with four replications is used. we provide four paper sheets . We write two letters A and on two other sheets of letter B. We mix the papers together and put them in the drawer of the table.With each of the qualified patients, one of the papers is taken out randomly and will be assigned to one of the two Bupivacaine 10 and Bupivacaine 12 mg groups, depending on whether the drawn sheet is either A or B. After the random drawn out of four sheets, all the papers will be returned to the drawer and again the above procedure will continue for the next four patients until it reaches the sample volume.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants knew the purpose of the study, but did not know which dose of bupivacaine would receive and the researcher did not know the dose.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences