This study analyzes serratus anterior plane block as postoperative analgesia in Modified Radical Mastectomy Surgery by assessing the level of pain, side effects, and complications.
Design
Randomized double blind clinical trial with parallel group design of 44 patients
Settings and conduct
This study was conducted ad Kariadi General Hospital, SAP block performed in the operating room under General Anesthesia, Numeric Rating Pain Score were assessed at the inpatient ward 4, 8, 12 and 24 hours after surgery
Participants/Inclusion and exclusion criteria
Inclusion criteria in this study are patients who underwent MRM, aging 18-59 years with American Society of Anesthesiologist (ASA) class I or II. The patient can also speak verbally and use Numerical Rating Scales (NRS). Patients with opioid allergies and taking drugs that were not match the research protocol were excluded from this study.
Intervention groups
The treatment group of SAP block were induced with anesthesia drugs propofol 2 mg/kg BW, rocuronium 0.6 mg/kg BW and were given maintenance with sevoflurane 1 MAC, intravenous paracetamol 1000 mg, and ketorolac intravenously 30 mg. Then were given SAP block using isobaric bupivacaine 0.25% with 20 cc volume
Main outcome variables
Numeric Rating Scale Pain Score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230219057451N2
Registration date:2023-08-09, 1402/05/18
Registration timing:retrospective
Last update:2023-08-09, 1402/05/18
Update count:0
Registration date
2023-08-09, 1402/05/18
Registrant information
Name
Taufan Pramadika
Name of organization / entity
Diponegoro University
Country
Indonesia
Phone
+62 622 47611196
Email address
taufanpramadika@ymail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-02, 1400/05/11
Expected recruitment end date
2022-01-02, 1400/10/12
Actual recruitment start date
2021-08-14, 1400/05/23
Actual recruitment end date
2021-10-30, 1400/08/08
Trial completion date
2021-11-20, 1400/08/29
Scientific title
Block of Serratus Anterior Plane As Postoperative Analgesia of Modified Radical Mastectomy
Public title
Peripheral Nerve Block of Serratus Anterior Plane As Analgesia After Modified Radical Mastectomy Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients who underwent MRM
Age 18-59 years old
Patient with American Society of Anesthesiologist (ASA) class I or II
The patient can also speak verbally and use Numerical Rating Scales (NRS).
Exclusion criteria:
Patients with opioid allergies were excluded from this study
Patient is known to be taking drugs that are not the research protocol
Age
From 18 years old to 59 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Actual sample size reached:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization that we used was simple random sampling procedure.
The randomization process was performed using numbers randomized by an internet-based computer program (www.randomization.com). The numbers were placed in a sealed envelope. The sealed envelope was opened when the patient arrived at the pre-operation room; then, the patient asked to take one of the papers containing a number. The intervention was given to the subjects selected through randomization based on number in the sealed envelope. Odd numbers were the intervention group, even numbers were the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
This was double blind clinical trial. The patients who reported their Numeric Rating Scales (NRS) Pain Score scores were blinded to the group assignment because the patient did not know whether they were the control group or the intervention group. The Serratus Anterior Plane Block was performed when patient still unconscious under General Anesthesia. The Investigator and Outcome assessors also blinded to group assignment because NRS pain score assessed after the surgery inthe inpatient ward. So, the outcome assessor and investigator didn’t know which one is the intervention group or control group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Health Research Ethic Committee RSUP DR. KARIADI SEMARANG
Street address
No 16, DR Sutomo Street
City
Semarang
Postal code
50244
Approval date
2021-06-23, 1400/04/02
Ethics committee reference number
No.843/EC/KEPK-RSDK/2021
Health conditions studied
1
Description of health condition studied
Breast Cancer Patient underwent Radical Mastectomy Surgery
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Numeric Rating Scale Pain Score
Timepoint
4 hours, 8 hours, 12 hours, 24 hours after surgery
Method of measurement
Numeric Rating Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group : The treatment group were induced with anesthesia drugs propofol 2 mg/kg BW, rocuronium 0.6 mg/kg BW and were given maintenance with sevoflurane 1 MAC, intravenous paracetamol 1000 mg, and ketorolac intravenously 30 mg. Then were given SAP block using isobaric bupivacaine 0.25% with 20 cc volume
Category
Treatment - Drugs
2
Description
Control group: The control group were induced with anesthesia drugs propofol 2 mg/kg BW, rocuronium 0.6 mg/kg BW and were given maintenance with sevoflurane 1 MAC, intravenous paracetamol 1000 mg, and ketorolac intravenously 30 mg. Then were given morphine 20mcg/kg/h continuous infusion as analgesic
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
RSUP dr Kariadi General Hospital
Full name of responsible person
Chandra Hermawan Manapa
Street address
No 16, dr Sutomo Street
City
Semarang
Postal code
50244
Phone
+62 622 48413476
Email
info@rskariadi.co.id
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
DIponegoro University of Medical Sciences
Full name of responsible person
Taufan Pramadika
Street address
No. 13, Prof. Sudarto Street
City
Semarang
Postal code
50275
Phone
+62 622 47460036
Email
humas@live.undip.ac.id
Web page address
https://fk.undip.ac.id/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
DIponegoro 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
Diponegoro University
Full name of responsible person
Taufan Pramadika
Position
Student
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No 32, Mintojiwo Dalam 3
City
Semarang
Province
Central Java
Postal code
50149
Phone
+62 24 7611196
Email
taufanpramadika@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Diponegoro University of Medical Sciences
Full name of responsible person
Mochamat, Mochamat
Position
Consultant Lecturer
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 15, Mintojiwo Timur
City
Semarang
Province
Central Java
Postal code
50149
Phone
+62 24 7605524
Email
dr.mochamat@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Diponegoro University
Full name of responsible person
Chandra Hermawan Manapa
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 4b . Bukit Cemara residence
City
Semarang
Province
Central Java
Postal code
50277
Phone
-
Email
chmanapa95@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Block of serratus anterior plane as postoperative analgesia of modified radical mastectomy
When the data will become available and for how long
3 months after publication
To whom data/document is available
for people working in academic institutions or people working in businesses can also apply to receive it
Under which criteria data/document could be used
as long as they asked permission to the author of this research
From where data/document is obtainable
they could obtain by contacting us via email
What processes are involved for a request to access data/document
first they must ask permission via email then they made us formal letter to use this data