comparison the effect of Erector Spinae Block VS Pectoral 1 Block on post operative pain , nausea and vomiting in breast mass surgeries ; a double blind randomized study
comparison the effect of Erector Spinae Block VS Pectoral 1 Block on post operative pain , nausea and vomiting in breast mass surgeries ; a double blind randomized study
Design
after consent for regional block , qualified person put in table of random numbers.before general anesthesia in aseptic field on sonography guide we did pecs1 block and erector spinae block(20cc rupivacaine .25%).patients received same drugs for general anesthesia.BIS was monitored(40-60).after surgery in full awake patients we measured pain(VAS score),nausa,vomiting.also need for narcotic in post opperation was evaluated.
Settings and conduct
after consent for regional block , qualified person put in table of random numbers.before general anesthesia in aseptic field on sonography guide we did pecs1 block and erector spinae block(20cc rupivacaine .25%).patients received same drugs for general anesthesia.BIS was monitored(40-60).after surgery in full awake patients we measured pain(VAS score),nausa,vomiting.also need for narcotic in post opperation was evaluated.
Participants/Inclusion and exclusion criteria
women age 18-50
ASA class 1-2
insensitivity to LA
No psychotic disorder
No addiction
no hemostasis disorder
no local skin infection
no use analgesic and NSAID drugs
Intervention groups
Pecs1 Block
Erector Spinae Block
Main outcome variables
need for narcotic
HEMODYNAMIC(BP-HR)
vomiting
nausa
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181126041760N1
Registration date:2019-07-23, 1398/05/01
Registration timing:retrospective
Last update:2019-07-23, 1398/05/01
Update count:0
Registration date
2019-07-23, 1398/05/01
Registrant information
Name
Houman Teymourian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2274 1174
Email address
houman72625@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-08, 1398/02/18
Expected recruitment end date
2019-07-13, 1398/04/22
Actual recruitment start date
2019-06-29, 1398/04/08
Actual recruitment end date
2019-07-11, 1398/04/20
Trial completion date
2019-07-13, 1398/04/22
Scientific title
comparison the effect of Erector Spinae Block VS Pectoral 1 Block on post operative pain , nausea and vomiting in breast mass surgeries ; a double blind randomized study
Public title
comparison the effect of Erector Spinae Block VS Pectoral 1 Block on post operative pain , nausea and vomiting in breast mass surgeries ; a double blind randomized study
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
women age 18-50
ASA class 1-2
insensitivity to LA
No psychotic disorder
No addiction
no hemostasis disorder
no local skin infection
no use analgesic and NSAID drugs
Exclusion criteria:
operation time more than 4 hours
excessive blood loss
changing procidure type
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
64
Actual sample size reached:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Related code was given to all patients by Computer based on Random number table and the patients were divided in two groups (simple randomization) . In one group the second anesthesiologist who wasn't aware from research type, blocked the patients based on closed envelope which include the type of block. The main researcher was not aware about the block was used for each patient.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and the anesthesiology resident were not aware about type of blocks. although the patient was aware and consent about Nerve block benefits, anesthesiologist who did the block was not participated in complition of questioner.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics research of shahid beheshti university of medical sciense
Street address
ERABI STREET
City
tehran
Province
Tehran
Postal code
1989934148
Approval date
2019-05-08, 1398/02/18
Ethics committee reference number
IR.SBMU.MSP.REC.1398.094
Health conditions studied
1
Description of health condition studied
Analgesia in chest wall operations
ICD-10 code
N60
ICD-10 code description
benign mammary dysplasia skin of breast
Primary outcomes
1
Description
PAIN
Timepoint
recovery/60minutes after recovery/2hours after recovery/4hours after recovery/6hours after recovery
Method of measurement
visual analogue scale
2
Description
nausea
Timepoint
recovery/60minutes after recovery/2hours after recovery/4hours after recovery/6hours after recovery
Method of measurement
questionnaire
3
Description
vomiting
Timepoint
recovery/60minutes after recovery/2hours after recovery/4hours after recovery/6hours after recovery
Method of measurement
questionnaire
4
Description
Blood Pressure
Timepoint
after injection/15minutes after/30minutes after/45minutes after/60minutes after/75minutes after/90minutes after/2hours after/3hours after/4hours after/6hours after
Method of measurement
BP monitoring (mmhg)
5
Description
herat rate
Timepoint
after injection/15minutes after/30minutes after/45minutes after/60minutes after/75minutes after/90minutes after/2hours after/3hours after/4hours after/6hours after
Method of measurement
HR monitoring
6
Description
need for narcotic
Timepoint
Recovery/60 minutes after recovery/2 hours after recovery/4 hours after recovery/6 hours after recovery
Method of measurement
patient file (macrogram)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: pecs1 block/ after consent for regional block , qualified person put in table of random numbers.before general anesthesia in aseptic field on sonography guide we did pecs1 block(20cc rupivacaine .25%).patients received drugs for general anesthesia.BIS was monitored(40-60).after surgery in full awake patients we measured pain(VAS score),nausa,need for narcotic,vomiting.
Category
Other
2
Description
Intervention group:erector soinae block/ after consent for regional block , qualified person put in table of random numbers.before general anesthesia in aseptic field on sonography guide we did erector spinae block (20cc rupivacaine .25%).patients received drugs for general anesthesia.BIS was monitored(40-60).after surgery in full awake patients we measured pain(VAS score),nausa,need for narcotic,vomiting.