Objective: Comparing the analgesic effect of bupivacaine, bupivacaine with adrenaline and bupivacaine with Epsom on the severity of pain after cesarean section in patients hospitalized in Rouhani Hospital of Babol University of Medical Science, 2015. Study design and population: Randomized single blind in 160 patients divided in to 4 groups. Inclusion criteria: Term and single pregnancy; ASA class I or II; Height: 180 to 170 centimeter; End pregnancy weight from 70 to 100 kilogram and undergoing elective cesarean section. Exclusion criteria: having hypersensitivity to amide local anesthetics; history of opioid drugs and calcium channel blockers; a tonic uterus after surgery or prolong surgical time more than 1.5 hours. Interventions: in first group: 50 milliliter normal saline is injected intravenously during 15 minutes .Then 10 milliliter of 0.5%bupivacaine injected subcutaneously in 10 separate injections after repairing fascia. Group (2): After injecting 50 milliliter normal saline, 0.1 milliliter of adrenaline 1:1000 with 10 milliliter of 0.5% bupivacaine injected subcutaneously after repairing fascia. Group (3): 50 milligrams per kilogram of magnesium sulfate 50% injected intravenously over 15 minutes and then 10 milliliter 0.5% bupivacaine that diluted with 20 milliliter of normal saline injected subcutaneously after repairing fascia. Control group: 50 milliliter normal saline injected intravenously over 15 minutes, and 20 milliliter normal saline injected subcutaneously. Severity of pain will evaluate by visual Analogous Scale (VAS) and hemodynamic indices (heart rate and blood pressure( in 2, 6, 12, 18 and 24 hours after surgery . Primary outcomes: severity of pain
General information
Acronym
ICP: Intra Cranial Pressure
IRCT registration information
IRCT registration number:IRCT2015090723926N1
Registration date:2016-02-18, 1394/11/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-18, 1394/11/29
Registrant information
Name
Rabeeh Rouhani
Name of organization / entity
Babol university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 11 3223 8256
Email address
r.rouhani@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Babol University of Medical Science
Expected recruitment start date
2015-07-29, 1394/05/07
Expected recruitment end date
2015-11-21, 1394/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the analgesic effect of bupivacaine, bupivacaine with adrenaline and bupivacaine with Epsom on the pain after cesarean section
Public title
Comparison of the effects of local anesthetics on the severity of pain after cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Term Pregnancy; single pregnancy; ASA class I or II; Height 180 to 170 cm,; End pregnancy weight from 100 to 70 kg and undergoing elective cesarean section.
Exclusion criteria: having hypersensitivity to amide local anesthetics (eg, bupivacaine and lidocaine), magnesium sulfate and epinephrine; history of opioid drugs; coagulopathy; seizure; cardiovascular disease; mental disorders; asthma and chronic obstructive pulmonary disease; high ICP; kidney disease; liver disease; atrioventricular block; history of calcium channel blockers; A tonic uterus after surgery or prolong surgical time more than 1.5 hours
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The patient is unaware of the method of sedation so this study is single blind and samples based on Table of random numbers will selected randomizely
Complications of anaesthesia during labour and delivery
Primary outcomes
1
Description
severity of pain
Timepoint
2, 6, 12, 18 and 24 hours after after starting the intervention
Method of measurement
visual Analogous Scale of pain
Secondary outcomes
1
Description
Blood pressure
Timepoint
2, 6, 12, 18 and 24 hours after starting intervention
Method of measurement
Observation and record
2
Description
Heart rate
Timepoint
2, 6, 12, 18 and 24 hours after starting intervention
Method of measurement
Observation and record
Intervention groups
1
Description
Intervention Group(1): 50 milliliter normal saline is injected intravenously during 15 minutes at the beginning of surgery .then 10 milliliter of 0.5%bupivacaine which is diluted with 10 milliliter of normal saline to total of 20 milliliter injected subcutaneously in 10 separate injections of 2 milliliter in volume after repairing fascia
Category
Treatment - Drugs
2
Description
Intervention group (2): At the beginning of surgery 50 milliliter normal saline intravenously injected. Then 0.1 milliliter of adrenaline 1:1000 + 10 milliliter of 0.5% bupivacaine is diluted with normal saline to total of 20 milliliter injected subcutaneously after repairing fascia
Category
Treatment - Drugs
3
Description
Intervention group (3): 50 milligrams per kilogram of magnesium sulfate 50% by volume of 50 milliliter normal saline can be injected intravenously over 15 minutes And 10 milliliter 0.5% bupivacaine with 20 milliliter of normal saline injected subcutaneously after repairing fascia
Category
Treatment - Drugs
4
Description
Control group: 50 milliliter normal saline injected intravenously over 15 minutes, and 20 milliliter normal saline injected in subcutaneous fat after repairing fascia
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Operation Room of Rouhani Hospital
Full name of responsible person
Rabeeh Rouhani
Street address
Rouhani Hospital, Ganjafroz Street, Babol
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Babol University of Medical Sciences
Full name of responsible person
Mohsen Rezazadeh
Street address
Babol university of medical science, Gangafroz Street, Babol
City
Babol
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, Babol University of Medical Sciences