Objective: the recent study is conducted for evaluating of the efficacy of serratus anterior block as an easier and safer method.60 Patients will be divided in two groups randomized. Design and Participants : Inclusion criteria are: patients with 20-60 years of age will be candidate for the elective breast surgery; ASA class I-II. Exclusion criteria: Emergency surgery; Patient refusal; Coagulopathy; Addiction to any opioids or psychoactive drugs; Anxiety disorders or depression; Any intraoperative complication. Intervention: Only in under studying group, sonographic guided anterior serratus block is made with 0.3 cc/kg of bupivacaine 0.2%, and then IV infusion pump is prescribed with the volume of 50 cc (fentanyl 15 cc + normal saline 35 cc) and setting of 2 cc bolus dose and 15 min lock out interval In both group .Main outcomes: Pain score will be recorded at 1 and 2 and 6 and 12 and 24 hours after block. And also Iv Apotel will be injected if numeric rating scale ≥3.Also the first time and count number of pump usage and total dosage of Fentanyl consumption will be detected and analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016011810599N6
Registration date:2017-01-06, 1395/10/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-06, 1395/10/17
Registrant information
Name
Poupak Rahimzadeh
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 9059
Email address
p-rahimzadeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research
Iran University Of Medical Sciences
Expected recruitment start date
2016-11-03, 1395/08/13
Expected recruitment end date
2017-03-03, 1395/12/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the efficacy of serratus anterior block on post mastectomy and mammaplasty pain
Public title
Evaluation the intra chest wall muscle injection effect on post breast surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria...
Patients with 20-60 years of age candidates for the elective breast surgery; ASA class I-II
Exclusion criteria…
Emergency surgery; Patient refusal; Coagulopathy; Addiction to any opioids or psychoaffective drugs; Anxiety disorders or depression; Any intraoperative complication
Age
From 20 years old to 60 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
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
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Niyayesh Street
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.IUMS.REC.1395.28929
Health conditions studied
1
Description of health condition studied
post mastectomy and mamoplasty pain
ICD-10 code
S20.0
ICD-10 code description
Contusion of breast
Primary outcomes
1
Description
Pain
Timepoint
1 and 6 and 12 and 24 hours after block
Method of measurement
VAS (visual analog scale)
Secondary outcomes
1
Description
Opioid necessity
Timepoint
1 and 6 and 12 and 24 hours after block
Method of measurement
The volume of drug use in pain management pumps
Intervention groups
1
Description
Intervention group, sonographic guided anterior serratus block is made with 0.3 cc/kg of bupivacaine 0.2%, and then IV infusion pump is prescribed with the volume of 50 cc (fentanyl 15 cc + normal saline 35 cc) and setting of 2 cc bolus dose and 15 min lock out interval.
Category
Treatment - Other
2
Description
Control group, only the infusion pump with the same contents and setting is prescribed
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool Akram hospital
Full name of responsible person
Rhimzadeh poupak MD
Street address
Tehran-Niyayesh street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research Iran University Of Medical Science
Full name of responsible person
Dr. Seyed Ali javad Musavi, MD
Street address
Tehran-Hemmat Highway
City
Tehran
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 Iran University Of Medical Science
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
Iran University of Medical Sciences
Full name of responsible person
Valiyan Borujeni Banafshe
Position
fellowship
Other areas of specialty/work
Street address
Rasool Akram hospital
City
Tehran
Postal code
Phone
+98 21 6435 2107
Fax
Email
banafshe6937@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Rahimzadeh Poupak MD
Position
Lecturer
Other areas of specialty/work
Street address
Tehran-Niyayesh street-Rasool Akram hospital
City
Tehran
Postal code
Phone
+98 21 6650 9059
Fax
Email
Poupak_rah@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Rahimzade Poupak MD
Position
Other areas of specialty/work
Street address
Niyayesh street-Rasool Akram hospital
City
Tehran
Postal code
Phone
+98 21 6650 9059
Fax
Email
poupak_rah@hotmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)