Comparison of pectoral nerve block Vs field block in transsexual patients undergoing breast reconstruction surgery
Design
This study is a single-blind randomized clinical trial in which the number of patients is determined according to the sample size formula and using a simple randomization method, which uses a random number table for each patient. The code is given and patients are randomly assigned to two treatment groups, with random code selection.The sample size in this study is 50 patients.
Settings and conduct
After standard monitoring, patients are anesthetized with intravenous drugs. After the surgery, the patients are placed under a nerve block in one of two ways. In the pectoral nerve block group, after the surgery, the ultrasound probe is placed on the Infraclavicular area and moved to the artery and the axillary vein above the first rib to the outside just above the junction of the pectoralis major and minor muscles at the window location. The syringe is then inserted between the two muscles and 10 ml of ropivacaine is injected to block the internal pectoral nerve as well as the external pectoral nerve . In the second group, the nerve block is performed by a surgeon.This study is being performed at Firoozgar Hospital in Tehran.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Transsexual patients with ASA I-II anesthesia score and candidate for mastectomy Exclusion criteria: Age less than 18 years or older than 50 years, Obesity, History of pregnancy or lactation,
Intervention groups
In this study, transsexual patients undergoing breast reconstruction surgery are divided into two groups : In the first group, the pectoral nerve block II is performed after surgery with an ultrasound machine.In the second group, the intercostal nerve block is performed after surgery.
Main outcome variables
Pain, nausea, vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151107024909N10
Registration date:2020-05-19, 1399/02/30
Registration timing:prospective
Last update:2020-05-19, 1399/02/30
Update count:0
Registration date
2020-05-19, 1399/02/30
Registrant information
Name
Faranak Rokhtabnak
Name of organization / entity
Iran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 6267
Email address
rolhtabnak.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-20, 1399/02/31
Expected recruitment end date
2020-09-19, 1399/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of pectoral nerve block Vs field block in transsexual patients undergoing breast reconstruction surgery
Public title
Comparison of pectoral nerve block Vs field block in transsexual patients undergoing breast reconstruction surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Transsexual patients with ASA I-II anesthesia score and candidate for mastectomy
Age range between 18 and 50 years
Exclusion criteria:
Age less than 18 years or older than 50 years
Obesity
History of pregnancy or lactation
History of allergy to anesthetics
History of hemorrhagic disease
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, a simple randomization method is used, which is done using a table of random numbers.To use the number of random numbers, we first determine the reading path of the table numbers (for example, top, bottom, left or right).Then we assume certain numbers for each group (for example, even numbers for intervention A and odd numbers for intervention B).Then we touch on one of the numbers and move in one of the predetermined directions and record the numbers and assign them to different groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, a person who is responsible for analyzing statistical data is not aware of the treatment process and study groups and the information is provided to that person in groups A and B. This helps the person's personal opinion not to affect the results
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town
City
Tehran
Province
Tehran
Postal code
1433933111
Approval date
2020-05-11, 1399/02/22
Ethics committee reference number
IR.IUMS.FMD.REC.1399.119
Health conditions studied
1
Description of health condition studied
breast reconstruction surgery
ICD-10 code
N65.0
ICD-10 code description
Deformity of reconstructed breast
Primary outcomes
1
Description
The severity of the pain
Timepoint
After surgery
Method of measurement
VAS scoring system
Secondary outcomes
1
Description
Nausea
Timepoint
After surgery
Method of measurement
Patient comment
2
Description
Vomiting
Timepoint
After surgery
Method of measurement
Patient comment
Intervention groups
1
Description
Intervention group: After standard monitoring, patients are anesthetized with intravenous drugs. After the surgery, the patients are placed under a nerve block in one of two ways. In the pectoral nerve block group, after the surgery, the ultrasound probe is placed on the Infraclavicular area and moved to the artery and the axillary vein above the first rib to the outside just above the junction of the pectoralis major and minor muscles at the window location. The syringe is then inserted between the two muscles and 10 ml of ropivacaine ۰/۲% is injected to block the internal pectoral nerve as well as the external pectoral nerve .
Category
Treatment - Other
2
Description
Control group: After standard monitoring, patients are anesthetized with intravenous drugs. After the surgery, the patients are placed under a nerve block in one of two ways.In the second groop the nerve block is performed by the surgeon himself and in the final stages before the surgery. Before the skin is sutured, the surgeon injects 3 cc of Ropevacaine ۰/۲% in three spaces between the T3 and T5 ribs in each space, and the injection time is recorded.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Faranak Rokhtabnak
Street address
Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8894 6267
Email
rkhtbnk@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Abbas Motavalian
Street address
Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8894 6267
Email
rkhtbnk@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Faranak Rokhtabnak
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8894 6267
Email
Rolhtabnak.f@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Faranak Rokhtabnak
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8894 6267
Email
rkhtbnk@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Faranak Rokhtabnak
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8894 6267
Email
rkhtbnk@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available