Evaluation of the effects of intra myometrial injection of lidocaine plus adrenaline on blood loss during myomectomy
Design
A double-blinded, randomized clinical trial, phase 3 with parallel groups, that includes a control group, design of 60 patients.
Settings and conduct
This clinical trial will be done in Alzahra Hospital in Rasht, on patients candidate for myomectomy. 60 patients randomly and will be divided in two groups:(Lidocaine and adrenaline)group and control group. Medications and placebo will be prepared and coded by an anesthetic technician who is not in the research. Patients will undergo surgery through laparotomy, midline or fish-tail cut. All myomectomy cases will be performed by one surgeon with one surgical method. The same general anesthetic protocol will be considered for all patients. In this study, patients, the surgeon, as well as the trained individual who collects the information, are BLIND. Amount of bleeding will be evaluated by the difference in hemoglobin before and after the operation and the number of transfused blood units.
Participants/Inclusion and exclusion criteria
Entry criteria: Women of reproductive age candidate for Myomectomy Patients with symptomatic Myoma without responding to medical treatments.
Non-Entry criteria: Adenomyosis of cervical myomas or peduncle Coagulation problems and recurrent vascular thrombosis Ischemic heart disease, cardiomyopathy، Women with multiple myomas
Intervention groups
Intervention group: In the treatment group, before the removal of the myoma, and after monitoring is done by the anesthetic team, 40 milliliters of the local anesthetic solution containing lidocaine 2% (3 milligrams per kilograms) + adrenaline 0.5 milliliters (from vial 1 milligram per milliliter)
In the control group, Normal saline is injected to the same extent.
Main outcome variables
Measurement of intra-operative blood loss during myomectomy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090525001946N10
Registration date:2019-07-30, 1398/05/08
Registration timing:registered_while_recruiting
Last update:2019-07-30, 1398/05/08
Update count:0
Registration date
2019-07-30, 1398/05/08
Registrant information
Name
Mandana Mansur Ghanaie
Name of organization / entity
Giulan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 5624
Email address
m_m_ghanaie@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-06, 1398/04/15
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of local- intra myometrial injection of lidocaine plus adrenaline in the amount of blood loss during myomectomy
Public title
The effect of injecting of lidocaine and adrenaline in myometrium on bleeding during myomectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women of reproductive age candidate for Myomectomy
Patients with symptomatic Myoma without responding to medical treatments (laparotomy, infertility for more than 3 years with myomectomy indication)
Pain and pelvic pressure
Urination frequency and constipation
The size of the uterus is less than 18 weeks.
Not accepting hysterectomy
Myoma grade 6-2 based on ultrasound
The cause of myoma bleeding is detected
Exclusion criteria:
Adenomyosis of cervical myomas or peduncle
Coagulation problems and recurrent vascular thrombosis
Ischemic heart disease, cardiomyopathy
Women with multiple myomas
Lidocaine susceptibility c
Uncontrolled hypertension
Hyperthyroidism
Seizure
Recent use of ergot alkaloids and vasoconstrictors, triangular antidepressants and monoamine oxidase inhibitors.
Liver disease
Diabetes, asthma, COPD
Malignancy
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
To produce random sequences in this clinical trial, we will use this site: http://www.graphpad.com/quickcalcs/index.cfm. A nurse who is not in the study will do it. Patients with inclusion criteria will randomly be divided into 2 groups by quadruple block method: intervention (lidocaine and adrenaline) and control.
Blinding (investigator's opinion)
Double blinded
Blinding description
Medications and placebo will be prepared and coded by an anesthetic technician who does not participate in this study. All myomectomy cases will be performed by one surgeon with one surgical method. The same general anesthetic protocol will be considered for all patients. In this study, the patient and the surgeon, as well as the trained person who collects the information and reports bleeding, are unaware of the type of treatment group and BLIND.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Guilan University Of Medical Sciences
Street address
Vice Chancellor for research, Shahid Siadati Avenue, Namjoo Street
City
Rasht
Province
Guilan
Postal code
4144666949
Approval date
2019-06-12, 1398/03/22
Ethics committee reference number
IR.GUMS.REC.1398.118
Health conditions studied
1
Description of health condition studied
Bleeding during myomectomy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The amount of bleeding of patients during myomectomy surgery
Timepoint
After the operation, according to the information recorded in the patient's file.
Method of measurement
With the difference in hemoglobin (g / dl) before and after operation and the number of transfused blood pack cells during operation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the treatment group, before the removal of the myoma, and after monitoring is done by the anesthetic team, 40 milliliters of the local anesthetic solution containing lidocaine 2% (3 milligrams per kilograms) + adrenaline 0.5 milliliters (from vial 1 milligram/milliliter) will be injected around Myoma and myometrium
Category
Prevention
2
Description
Control group: In the control group, before the removal of the myoma, and after monitoring is done by the anesthetic team, 40 milliliters of normal saline will be injected around Myoma and myometrium
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Dr mandana mansoor ghanaee
Street address
Opposite Shahid Azodi Stadium, Namjoo Street
City
Rasht
Province
Guilan
Postal code
4144654839
Phone
+98 13 3336 9324
Fax
+98 13 3336 9024
Email
azzahra@gums.ac.ir
Web page address
http://www.gums.ac.ir/azzahra
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Doctor Shadman Nemati
Street address
Vice Chancellor for research of Guilan,Shahid Siadati Avenue, Namjoo Street
City
Rasht
Province
Guilan
Postal code
4144666949
Phone
+98 13 3333 5821
Fax
+98 13 3333 6395
Email
drshadmannemati_ent@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Mandana Mansur Ghanaie
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Reproduction Health Research Center-Alzahra hospital-Namjo street
City
Rasht
Province
Guilan
Postal code
4144654839
Phone
+98 13 1322 5624
Fax
Email
m_m_ghanaie@gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mandana Mansur Ghanaie
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Reproduction Health Research Center-Alzahra hospital-Namjo street
City
Rasht
Province
Guilan
Postal code
4144654839
Phone
+98 13 1322 5624
Fax
Email
m_m_ghanaie@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohadese Ahmadi
Position
Research Expert/(MSc) English
Latest degree
Master
Other areas of specialty/work
Research Expert
Street address
Anestesiology Reseaech Center, Alzahra Hospital, Namjoo Street
City
rasht
Province
Guilan
Postal code
4144654839
Phone
+98 13 3336 9328
Fax
Email
p.ahmadi2311@gmail.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