Comparison of Ropivacaine combination with Dexamethasone analgesic effect and Ropivacaine combination with dexmedetomidine on pain after cesarean section by TAP Block method
Comparison of Ropivacaine combination with Dexamethasone analgesic effect and Ropivacaine combination with dexmedetomidine on pain after cesarean section by TAP Block method
Design
The study will have two 50 member groups. Random block randomization will be done by statistical software. The Phase 3 clinical trial study will be performed on 100 patients.
Settings and conduct
Study place: Delivery ward of Ayatollah Mousavi Hospital in Zanjan; Type of blinding: single-blind. How to blind: Patients will not be informed about the injected drug for bilateral block and only the researcher and the person injecting the drug are aware of this.
Participants/Inclusion and exclusion criteria
Inclusion criteria: ASA(American Society of Anesthesiologists) grade 1 or 2; Ability to report the patient of his pain by the standard visual analog scale(VAS); Conscious satisfaction with the patient to participate in the study; Candidate for cesarean section under anesthesia with TAP(transverse abdominis plane) block.
Non-inclusion criteria: history of anaphylaxis to dexmedetomidine or ropivacaine; history of substance abuse; History of coagulopathy
Intervention groups
Intervention group 1: Ropivacaine + dexmedetomidine will receive 15 cc of 2% ropivacaine with 100 micrograms of dexmedetomidine by bilateral TAP block method. Intervention group 2: Ropivacaine + dexamethasone by bilateral TAP block method will receive 15 cc of 2% ropivacaine with 2 cc of dexamethasone.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210302050553N1
Registration date:2021-05-14, 1400/02/24
Registration timing:prospective
Last update:2021-05-14, 1400/02/24
Update count:0
Registration date
2021-05-14, 1400/02/24
Registrant information
Name
Mohammad Hadi Molseghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3313 1851
Email address
molseghi@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2021-09-21, 1400/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Ropivacaine combination with Dexamethasone analgesic effect and Ropivacaine combination with dexmedetomidine on pain after cesarean section by TAP Block method
Public title
Comparison of analgesic effect of rupivacaine with dexamethasone and rupivacaine with dexmedetomidine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ASA(American Society of Anesthesiologists) grade 1 or 2
The patient's ability to report the extent of their pain by criteria VAS(visual analog scale)
Conscious consent of the patient to participate in the study
Candidate for cesarean section under anesthesia with TAP(transverse abdominis plane) block
Exclusion criteria:
History of anaphylaxis to dexmedetomidine or ropivacaine
History of drug abuse
History of coagulopathy
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randomization of patients will be random block. Based on the calculated sample size, the sample size in each group is 25 patients. positions are considered as 6 positions according to 2 groups: AABB, ABAB, BBAA, BABA, BAAB, ABBA. The positions are written on 6 cards and the selection of positions and their order will be randomly selected among the cards. The order of exit of the cards is written and will determine the order of recruitment of intervention groups based on it. Individuals will be assigned on a per-shift basis. An individual randomization unit will be used for the study. The information of registered persons will be anonymous and without their personal information.
Blinding (investigator's opinion)
Single blinded
Blinding description
Pregnant women participating in the study will be unaware of the type of drug used to perform the TAP block and will not be given any information about the drug used at the time of injection, and only the researcher and injector will be informed of the type of drug.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Science
Street address
Gavazang
City
Zanjan
Province
Zanjan
Postal code
4513956183
Approval date
2021-04-11, 1400/01/22
Ethics committee reference number
IR.ZUMS.REC.1400.022
Health conditions studied
1
Description of health condition studied
Post procedural pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
Pain of patients after cesarean section
Timepoint
24 hours after surgery
Method of measurement
By visual analog scale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Bilateral block method by transverse abdominis plane, 15 cc of 2% ropivacaine, and 100 micrograms of dexmedetomidine will be injected between the transverse abdominis and rectus abdominis muscles.
Category
Treatment - Drugs
2
Description
Intervention group: Bilateral block method by transverse abdominis plane, 15 cc of 2% ropivacaine 2% with 2 cc of dexamethasone will be injected between the transverse abdominis and rectus abdominis muscles.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Mousavi Hospital
Full name of responsible person
Mohammad Reza Jamshidi
Street address
Gavazang
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Email
mr.jamshidi47@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Alireza Shoghli
Street address
Gavazang
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Email
shoghli@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Mohammad Reza Jamshidi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Gavazang
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Email
mr.jamshidi47@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mohammad Reza Jamshidi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Gavazang
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Email
mr.jamshidi47@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mohammad Reza Jamshidi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Gavazang
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Email
mr.jamshidi47@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