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Protocol summary
aim to assess the analgesic effect of adding calcitonin to bupivacaine in erector spine plane block
Aim to assess the analgesic effect of adding calcitonin to bupivacaine in erector spine plane block
aimAim to assess the analgesic effect of adding calcitonin to bupivacaine in erector spine plane block
double blind randomized control trail
Double blind randomized control trial, randomization will done before surgery by computer generated random numbers using statistical software SPSS (IBMSPSS Version 28.0).patient allocated to control group (A) and intervention group (B)with allocation ratio 1:1 ,phase IV clinical trail ,
doubleDouble blind randomized control trial, randomization will done before surgery by computer generated random numbers using statistical software SPSS (IBMSPSS Version 28.0).patient allocated to control group (A) and intervention group (B)with allocation ratio 1:1 ,phase IV clinical trail ,
main operation theater IN OCMU CENTER in MANSOURA university hospital under general anesthesia patient will receive unilateral erector spine plane block ultrasound guided in lateral decubitus position with either bupivacaine alone or bupivacaine plus calcitonin participant ,care giver and investigators all are blind to the components of solution injected during block as it will be prepared by anesthesia technician in medication room before patient enter the room
Main operation theater in OCMU center in Mansoura university hospital under general anesthesia, patient will receive unilateral erector spine plane block ultrasound guided in lateral decubitus position with either bupivacaine alone or bupivacaine plus calcitonin. Participant, caregiver, and investigators all are blind to the components of solution injected during block as it will be prepared by pharmacist in medication room before patient enter the room.
mainMain operation theater INin OCMU CENTERcenter in MANSOURAMansoura university hospital under general anesthesia, patient will receive unilateral erector spine plane block ultrasound guided in lateral decubitus position with either bupivacaine alone or bupivacaine plus calcitonin participant . Participant,care giver caregiver, and investigators all are blind to the components of solution injected during block as it will be prepared by anesthesia technicianpharmacist in medication room before patient enter the room.
control group group A bupivacaine
study group group B bupivacaine plus calcitonin
Control group (group A) bupivacaine.
Intervention group (group B): bupivacaine plus calcitonin.
controlControl group (group A) bupivacaine study. Intervention group (group B): bupivacaine plus calcitonin.
rescue analgesia, total opioid requirement, inflammatory mediator ,patient satisfaction
rescue analgesia ( first analgesia request ), total opioid requirement (morphine in 24 hour after operation ), inflammatory mediator (IL6,IL10,TNF)
rescue analgesia ( first analgesia request ), total opioid requirement (morphine in 24 hour after operation ), inflammatory mediator ,patient satisfaction(IL6,IL10,TNF)
General information
2
4
24
2022-07-30, 1401/05/08
2022-11-30, 1401/09/09
2022-0711-30 00:00:00
empty
change the time interval for secondary outcome because practically it is difficult to let the patient come again after 7 days
change the time interval for secondary outcome because practically it is difficult to let the patient come again after 7 days
Seventy female patients aged 18–65 years,
American Society of Anesthesiologists physical status I and II,
undergoing unilateral breast cancer surgery (modified radical mastectomy, breast conservational surgery, simple mastectomy and axillary clearance)
Female patients
Aged 18–65 years,
American Society of Anesthesiologists physical status I and II,
Undergoing unilateral breast cancer surgery (modified radical mastectomy, breast conservational surgery, simple mastectomy and axillary clearance)
Seventy femaleFemale patients agedAged 18–65 years, American Society of Anesthesiologists physical status I and II, undergoingUndergoing unilateral breast cancer surgery (modified radical mastectomy, breast conservational surgery, simple mastectomy and axillary clearance)
Patients will be randomized by computer-generated random numbers, on the day of surgery. They will allocated to either control group— group “A”, who received only bupivacaine , or study group— group “B” who received calcitonin plus bupivacaine in the ESP block with general anesthesia.
patients will randomly allocated to control group (A) and study group (B) with allocated ratio 1:1 .Randomization will done before surgery by computer generated random ,Version28.0 . Opaque sealed sequentially numbered envelopes containing the patients` codes will used and opened just before anethesia by physician who will not involved in the study A pharmacist will prepare the drug mixture. The patients will be allocated to either control group— group “A”, who receive only bupivacaine , or study group— group “B” who receive calcitonin plus bupivacaine in the ESP block with general anesthesia.
Patientspatients will randomly allocated to control group (A) and study group (B) with allocated ratio 1:1 .Randomization will done before surgery by computer generated random ,Version28.0 . Opaque sealed sequentially numbered envelopes containing the patients` codes will used and opened just before anethesia by physician who will not involved in the study A pharmacist will prepare the drug mixture. The patients will be randomized by computer-generated random numbers, on the day of surgery. They will allocated to either control group— group “A”, who receivedreceive only bupivacaine , or study group— group “B” who receivedreceive calcitonin plus bupivacaine in the ESP block with general anesthesia.
Primary outcomes
#1
time point measured from the end of surgery to request of analgesic or numerical rating scale (VAS)≥ 4
time point measured from the end of surgery to request of analgesic
time point measured from the end of surgery to request of analgesic or numerical rating scale (VAS)≥ 4
visual analogue scale to measure pain
visual analogue scale to measure pain assessment of pain if VAS is more than 3 patient will receive morphine 10 Mg intramuscular and reassess after 30 min for pain relieve .
visual analogue scale to measure pain assessment of pain if VAS is more than 3 patient will receive morphine 10 Mg intramuscular and reassess after 30 min for pain relieve .
Secondary outcomes
#1
total opioid requirement, inflammatory mediators
total opioid requirement
total opioid requirement, inflammatory mediators
before intervention and 2,7 days after intervention
24 hour post operative
before intervention and 2,7 days after intervention24 hour post operative
lab kit to measure inflammatory mediators
amount of drug prescribed amount of morphine consumption in Mg in 24 hour after the end of surgery
lab kit to measure inflammatory mediatorsamount of drug prescribed amount of morphine consumption in Mg in 24 hour after the end of surgery
#2
empty
inflammatory mediators (interleukin 6,interlokin 10, and tumor necrotic factor
inflammatory mediators (interleukin 6,interlokin 10, and tumor necrotic factor
empty
before intervention and 2hour post operative ,12 hour post operative , and 24 hour post operative
before intervention and 2hour post operative ,12 hour post operative , and 24 hour post operative
empty
lab kit to measure inflammatory mediators
lab kit to measure inflammatory mediators
Intervention groups
#1
Control group: using ultrasound guided unilateral erector spine plane block after induction of general anesthesia ,60 patient in the group solution used for injection will be 20 ml bupivacaine 0.25%
control group: ultrasound guided unilateral erector spine plane block will be performed under complete aseptic condition after induction of general anesthesia directly and 15 min before skin incision with 100mm 21 G needle while the patient in unilateral position ,60 patient in the group solution used for injection will be (30 ml bupivacaine 0.25% plus 2ml saline )
Controlcontrol group: using ultrasound guided unilateral erector spine plane block will be performed under complete aseptic condition after induction of general anesthesia directly and 15 min before skin incision with 100mm 21 G needle while the patient in unilateral position ,60 patient in the group solution used for injection will be 20(30 ml bupivacaine 0.25% plus 2ml saline )
#2
Intervention group: using ultrasound guided unilateral erector spine plane block after induction of general anesthesia ,60 patient in the group solution used for injection will be 20 ml bupivacaine 0.25% plus calcitonin 50 international unit(IU)
Intervention group: ultrasound guided unilateral erector spine plane block will be performed under complete aseptic condition after induction of general anesthesia directly and 15 min before skin incision with 100mm 21 G needle while the patient in unilateral position ,60 patient in the group solution used for injection will be (30 ml bupivacaine 0.25% plus 50 IU calcitonin in 2ml saline )
Intervention group: using ultrasound guided unilateral erector spine plane block will be performed under complete aseptic condition after induction of general anesthesia directly and 15 min before skin incision with 100mm 21 G needle while the patient in unilateral position ,60 patient in the group solution used for injection will be 20(30 ml bupivacaine 0.25% plus 50 IU calcitonin 50 international unit(IUin 2ml saline )
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Mansoura university hospital
Name of organization / entity - Persian:
Full name of responsible person - English: zenat Eldadamony Mohamed
Full name of responsible person - Persian:
Position - English: lecturer
Position - Persian:
Latest degree: phd
Area of specialty/work: 24
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: algomhorria
Street address - Persian:
City - English: Mansoura
City - Persian:
Province: Dakhahlia
Province - English: Dakhahlia
Province - Persian:
contact.provinces_available:
Country: Egypt
Postal code: 35516
Phone: +20 122 543 9066
Mobile: +20 122 543 9066
Fax: +20 50 2267016
Email: zenatddd@gmail.com
Web page address: http://irb.mans.edu.eg
contact.organization_id:
Name of organization / entity - English: Mansoura University Hospital
Name of organization / entity - Persian:
Full name of responsible person - English: Zenat Eldadamony Mohamed
Full name of responsible person - Persian:
Position - English: Lecturer
Position - Persian:
Latest degree: phd
Area of specialty/work: 24
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Algomhorria
Street address - Persian:
City - English: Mansoura
City - Persian:
Province: Dakhahlia
Province - English: Dakhahlia
Province - Persian:
contact.provinces_available:
Country: Egypt
Postal code: 35516
Phone: +20 122 543 9066
Mobile: +20 122 543 9066
Fax: +20 50 2267016
Email: zenatddd@gmail.com
Web page address: Http://irb.mans.edu.eg
contact.organization_id: Name of organization / entity - English: Mansoura university hospitalUniversity Hospital Name of organization / entity - Persian: Full name of responsible person - English: zenatZenat Eldadamony Mohamed Full name of responsible person - Persian: Position - English: lecturerLecturer Position - Persian: Latest degree: phd Area of specialty/work: 24 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: algomhorriaAlgomhorria Street address - Persian: City - English: Mansoura City - Persian: Province: Dakhahlia Province - English: Dakhahlia Province - Persian: contact.provinces_available: Country: Egypt Postal code: 35516 Phone: +20 122 543 9066 Mobile: +20 122 543 9066 Fax: +20 50 2267016 Email: zenatddd@gmail.com Web page address: httpHttp://irb.mans.edu.eg
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: MANSOURA UNIVERSITY
Name of organization / entity - Persian:
Full name of responsible person - English: Zenat Eldadamony Mohamed
Full name of responsible person - Persian:
Position - English: LECTURER
Position - Persian:
Latest degree: phd
Area of specialty/work: 24
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: algomhorria
Street address - Persian:
City - English: Mansoura
City - Persian:
Province: Dakahalia
Province - English: Dakahalia
Province - Persian:
contact.provinces_available:
Country: Egypt
Postal code: 35516
Phone: +20 122 543 9066
Mobile: +20 122 543 9066
Fax: +20 50 2267016
Email: zenatddd@gmail.com
Web page address: http://irb.mans.edu.eg
contact.organization_id:
Name of organization / entity - English: Mansoura University
Name of organization / entity - Persian:
Full name of responsible person - English: Zenat Eldadamony Mohamed
Full name of responsible person - Persian:
Position - English: Lecturer
Position - Persian:
Latest degree: phd
Area of specialty/work: 24
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Algomhorria
Street address - Persian:
City - English: Mansoura
City - Persian:
Province: Dakahalia
Province - English: Dakahalia
Province - Persian:
contact.provinces_available:
Country: Egypt
Postal code: 35516
Phone: +20 122 543 9066
Mobile: +20 122 543 9066
Fax: +20 50 2267016
Email: zenatddd@gmail.com
Web page address: Http://irb.mans.edu.eg
contact.organization_id: Name of organization / entity - English: MANSOURA UNIVERSITYMansoura University Name of organization / entity - Persian: Full name of responsible person - English: Zenat Eldadamony Mohamed Full name of responsible person - Persian: Position - English: LECTURERLecturer Position - Persian: Latest degree: phd Area of specialty/work: 24 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: algomhorriaAlgomhorria Street address - Persian: City - English: Mansoura City - Persian: Province: Dakahalia Province - English: Dakahalia Province - Persian: contact.provinces_available: Country: Egypt Postal code: 35516 Phone: +20 122 543 9066 Mobile: +20 122 543 9066 Fax: +20 50 2267016 Email: zenatddd@gmail.com Web page address: httpHttp://irb.mans.edu.eg
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Mansoura university hospital
Name of organization / entity - Persian:
Full name of responsible person - English: zenat Eldadamony Mohamed
Full name of responsible person - Persian:
Position - English: lecturer
Position - Persian:
Latest degree: phd
Area of specialty/work: 24
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: algomhorria
Street address - Persian:
City - English: Mansoura
City - Persian:
Province: Dakhahlia
Province - English: Dakhahlia
Province - Persian:
contact.provinces_available:
Country: Egypt
Postal code: 35516
Phone: +20 122 543 9066
Mobile: +20 122 543 9066
Fax: +20 50 2267016
Email: zenatddd@gmail.com
Web page address: http://irb.mans.edu.eg
contact.organization_id:
Name of organization / entity - English: Mansoura university hospital
Name of organization / entity - Persian:
Full name of responsible person - English: Zenat Eldadamony Mohamed
Full name of responsible person - Persian:
Position - English: Lecturer
Position - Persian:
Latest degree: phd
Area of specialty/work: 24
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Algomhorria
Street address - Persian:
City - English: Mansoura
City - Persian:
Province: Dakhahlia
Province - English: Dakhahlia
Province - Persian:
contact.provinces_available:
Country: Egypt
Postal code: 35516
Phone: +20 122 543 9066
Mobile: +20 122 543 9066
Fax: +20 50 2267016
Email: zenatddd@gmail.com
Web page address: http://irb.mans.edu.eg
contact.organization_id: Name of organization / entity - English: Mansoura university hospital Name of organization / entity - Persian: Full name of responsible person - English: zenatZenat Eldadamony Mohamed Full name of responsible person - Persian: Position - English: lecturerLecturer Position - Persian: Latest degree: phd Area of specialty/work: 24 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: algomhorriaAlgomhorria Street address - Persian: City - English: Mansoura City - Persian: Province: Dakhahlia Province - English: Dakhahlia Province - Persian: contact.provinces_available: Country: Egypt Postal code: 35516 Phone: +20 122 543 9066 Mobile: +20 122 543 9066 Fax: +20 50 2267016 Email: zenatddd@gmail.com Web page address: http://irb.mans.edu.eg
Protocol summary
Study aim
Aim to assess the analgesic effect of adding calcitonin to bupivacaine in erector spine plane block
Design
Double blind randomized control trial, randomization will done before surgery by computer generated random numbers using statistical software SPSS (IBMSPSS Version 28.0).patient allocated to control group (A) and intervention group (B)with allocation ratio 1:1 ,phase IV clinical trail ,
Settings and conduct
Main operation theater in OCMU center in Mansoura university hospital under general anesthesia, patient will receive unilateral erector spine plane block ultrasound guided in lateral decubitus position with either bupivacaine alone or bupivacaine plus calcitonin. Participant, caregiver, and investigators all are blind to the components of solution injected during block as it will be prepared by pharmacist in medication room before patient enter the room.
Participants/Inclusion and exclusion criteria
one hundred twenty female patients aged 18–65 years, American Society of Anesthesiologists physical status I and II, undergoing unilateral breast cancer surgery (modified radical mastectomy, breast conservational surgery, simple mastectomy and axillary clearance) were included. Exclusion criteria included patient refusal, history of bronchial asthma, infection at the injection site, spinal deformities, coagulation disorders, allergy to local anesthetics, history of opioid usage for chronic pain and cognitive/psychiatric disorders.
Intervention groups
Control group (group A) bupivacaine.
Intervention group (group B): bupivacaine plus calcitonin.
Main outcome variables
rescue analgesia ( first analgesia request ), total opioid requirement (morphine in 24 hour after operation ), inflammatory mediator (IL6,IL10,TNF)
General information
Reason for update
change the time interval for secondary outcome because practically it is difficult to let the patient come again after 7 days
Acronym
IRCT registration information
IRCT registration number:IRCT20220212054002N1
Registration date:2022-03-18, 1400/12/27
Registration timing:prospective
Last update:2022-10-02, 1401/07/10
Update count:1
Registration date
2022-03-18, 1400/12/27
Registrant information
Name
zenat eldadamony
Name of organization / entity
Mansoura university
Country
Egypt
Phone
+20 122 543 9066
Email address
zenatddd@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-01, 1400/01/12
Expected recruitment end date
2022-06-30, 1401/04/09
Actual recruitment start date
2022-04-01, 1401/01/12
Actual recruitment end date
2022-06-30, 1401/04/09
Trial completion date
2022-11-30, 1401/09/09
Scientific title
analgesic effect of adding calcitonin to bupivacaine in erector spine plane block for breast surgery ,double blind randomized study
Public title
calcitonin in mastectomy pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female patients
Aged 18–65 years,
American Society of Anesthesiologists physical status I and II,
Undergoing unilateral breast cancer surgery (modified radical mastectomy, breast conservational surgery, simple mastectomy and axillary clearance)
Exclusion criteria:
patient refusal,
history of bronchial asthma
spinal deformities,
coagulation disorders,
allergy to local anesthetics,
history of opioid usage for chronic pain
cognitive/psychiatric disorders
infection at the injection site
Age
From 18 years old to 70 years old
Gender
Female
Phase
4
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
130
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
patients will randomly allocated to control group (A) and study group (B) with allocated ratio 1:1 .Randomization will done before surgery by computer generated random ,Version28.0 . Opaque sealed sequentially numbered envelopes containing the patients` codes will used and opened just before anethesia by physician who will not involved in the study A pharmacist will prepare the drug mixture. The patients will be allocated to either control group— group “A”, who receive only bupivacaine , or study group— group “B” who receive calcitonin plus bupivacaine in the ESP block with general anesthesia.
Blinding (investigator's opinion)
Double blinded
Blinding description
participant ,care givers ,investigators all are blind to component of solution injected in unilateral erector spine plane block ,under ultrasound after general anesthesia .As solution will be prepared by anesthesia technician in medication room before patient enter the operation room according to allocated randomized number .
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
INSTITUATIONAL RESEARCH BOARD ,IRB
Street address
algomhorria street
City
Mansoura
Postal code
35516
Approval date
2022-01-29, 1400/11/09
Ethics committee reference number
R.21.12.1558.R1.R2-2022/01/29
Health conditions studied
1
Description of health condition studied
acute post mastectomy pain and post operative inflammatory reaction
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
time to rescue analgesia (opioid) in post operative period
Timepoint
time point measured from the end of surgery to request of analgesic
Method of measurement
visual analogue scale to measure pain assessment of pain if VAS is more than 3 patient will receive morphine 10 Mg intramuscular and reassess after 30 min for pain relieve .
Secondary outcomes
1
Description
total opioid requirement
Timepoint
24 hour post operative
Method of measurement
amount of drug prescribed amount of morphine consumption in Mg in 24 hour after the end of surgery
2
Description
inflammatory mediators (interleukin 6,interlokin 10, and tumor necrotic factor
Timepoint
before intervention and 2hour post operative ,12 hour post operative , and 24 hour post operative
Method of measurement
lab kit to measure inflammatory mediators
Intervention groups
1
Description
control group: ultrasound guided unilateral erector spine plane block will be performed under complete aseptic condition after induction of general anesthesia directly and 15 min before skin incision with 100mm 21 G needle while the patient in unilateral position ,60 patient in the group solution used for injection will be (30 ml bupivacaine 0.25% plus 2ml saline )
Category
Treatment - Drugs
2
Description
Intervention group: ultrasound guided unilateral erector spine plane block will be performed under complete aseptic condition after induction of general anesthesia directly and 15 min before skin incision with 100mm 21 G needle while the patient in unilateral position ,60 patient in the group solution used for injection will be (30 ml bupivacaine 0.25% plus 50 IU calcitonin in 2ml saline )
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mansoura university
Full name of responsible person
Mona Gad Elebiedy
Street address
algomhorria
City
Mansoura
Postal code
35516
Phone
+20 122 543 9066
Fax
+20 50 2267016
Email
zenatddd@gmail.com
Web page address
https://irb.mans.edu.eg
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mansoura university
Full name of responsible person
Mansoura university
Street address
ALGOMHORRIA
City
Mansoura
Postal code
35516
Phone
+20 122 543 9066
Fax
+20 50 2267016
Email
zenatddd@gmail.com
Web page address
http://irb.mans.edu.eg
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mansoura university
Proportion provided by this source
10
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
Mansoura University Hospital
Full name of responsible person
Zenat Eldadamony Mohamed
Position
Lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Anesthesiology
Street address
Algomhorria
City
Mansoura
Province
Dakhahlia
Postal code
35516
Phone
+20 122 543 9066
Fax
+20 50 2267016
Email
zenatddd@gmail.com
Web page address
Http://irb.mans.edu.eg
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mansoura University
Full name of responsible person
Zenat Eldadamony Mohamed
Position
Lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Anesthesiology
Street address
Algomhorria
City
Mansoura
Province
Dakahalia
Postal code
35516
Phone
+20 122 543 9066
Fax
+20 50 2267016
Email
zenatddd@gmail.com
Web page address
Http://irb.mans.edu.eg
Person responsible for updating data
Contact
Name of organization / entity
Mansoura university hospital
Full name of responsible person
Zenat Eldadamony Mohamed
Position
Lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Anesthesiology
Street address
Algomhorria
City
Mansoura
Province
Dakhahlia
Postal code
35516
Phone
+20 122 543 9066
Fax
+20 50 2267016
Email
zenatddd@gmail.com
Web page address
http://irb.mans.edu.eg
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
IPD collected for primary outcome
When the data will become available and for how long
available starting 6 month after publication
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
academic purpose
From where data/document is obtainable
email address// zenatddd@gmail .com
What processes are involved for a request to access data/document