Protocol summary

Study aim
Determining the effective drug and reducing the use of narcotic drugs
Design
Two arm parallel group randomized trial with blinded postoperative care and outcome assessment
Settings and conduct
Patients undergoing thoracotomy surgery in Imam Khomeini Hospital, Ahvaz Age 18 to 60 years; Class I or II physical condition Patients are randomly assigned to one of the two groups of ropivacaine (R) or ropivacaine-dexmedetomidine (RD). The grouping of patients is random and the patient and the person in charge of registering the patient's information are not aware of the patient's allocation group. Information is entered into the checklist, which includes name, age, gender, height and weight, BMI, pain score, duration of operation, length of stay in ICU, time of walking in ICU and amount of narcotics a
Participants/Inclusion and exclusion criteria
The criteria for entering the study are: Age 18 to 60 years; Class I or II physical status according to the criteria of the Association of Anesthesiologists (ASA); body mass index (BMI) less than 40; No history of drug or alcohol abuse; absence of pregnancy or breastfeeding; No history of coagulation problems or use of anticoagulants; jump fraction higher than 30%; No history of conduction heart block; absence of acute or chronic hepatitis; lack of history of psychiatric diseases; No need for complementary renal treatments or a history of kidney failure; Absence of neuropathy: Exclusion criteria: sensitivity to study drugs and unwillingness of patients to cooperate.
Intervention groups
ropivacaine (R)-ropivacaine-dexmedetomidine(RD)
Main outcome variables
vagus nerve stimulation (VNS)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221222056890N1
Registration date: 2024-02-15, 1402/11/26
Registration timing: registered_while_recruiting

Last update: 2024-02-15, 1402/11/26
Update count: 0
Registration date
2024-02-15, 1402/11/26
Registrant information
Name
Mahbobeh Rashidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 916 616 8655
Email address
rashidi-m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-11, 1402/11/22
Expected recruitment end date
2024-03-10, 1402/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of serratus anterior plate block with ropivacaine and ropivacaine-dexmedetomidine combination to reduce pain in patients after thoracotomy surgery
Public title
Comparison of anterior serratus plate block with ropivacaine and ropivacaine-dexmedetomidine combination for pain reduction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 60 years;Class I or II physical status according to the criteria of the Association of Anesthesiologists (ASA);body mass index (BMI) less than 40;No history of drug or alcohol abuse;absence of pregnancy or breastfeeding;No history of coagulation problems or use of anticoagulants;jump fraction higher than 30%;No history of conduction heart block (except first degree heart block and controlled atrial fibrillation);absence of acute or chronic hepatitis;lack of history of psychiatric diseases;No need for complementary renal treatments or a history of kidney failure; No neuropathy
Exclusion criteria:
Allergy to study drugs and patients' unwillingness to cooperate.
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 74
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of patients is done in random order in this way, which is done using the randomization table. The information is entered into the checklist. The checklists are already numbered by the statistical consultant, and this numbering is the basis for the allocation of patients, but the allocation of numbers to groups will not be revealed until the results are analyzed
Blinding (investigator's opinion)
Double blinded
Blinding description
In this way, the patient and the specialist doctor are not aware of the type of medicine.Allocation of patients is done in random order in this way, which is done using the randomization table.The patient and the person responsible for registering the patient's information are unaware of the patient's diagnostic group.The information is entered into the checklist. Checklists are already numbered by a statistical consultant and this numbering is the basis of patient allocation, but the allocation of numbers to groups will not be revealed until the results are analyzed. The person responsible for injecting the drug is aware of the injected drug, but in the collection process And data analysis does not participate.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Golestan Hospital Research
Street address
Golestan Ave, Golestan Hospital
City
ahvaz
Province
Khouzestan
Postal code
1579461357
Approval date
2024-02-07, 1402/11/18
Ethics committee reference number
IR.AJUMS.REC.1402.615

Health conditions studied

1

Description of health condition studied
Pain reduction in patients after thoracotomy surgery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Verbal Numeric Scale (VNS)
Timepoint
The patient expresses her/his pain as a number between 0 and 10, where 0 means no pain and 10 is the maximum pain.
Method of measurement
Based on the patient's expression of pain intensity

Secondary outcomes

1

Description
ICU admission
Timepoint
2-6-12-24-48
Method of measurement
Visual Analogue Scale

Intervention groups

1

Description
Intervention group: 0.4 cc/kg of 0.2% Ropivacaine solution
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz Imam Khomeini Hospital
Full name of responsible person
Mahbobeh Rashidi
Street address
24 metery street, east sahely highway, ahvaz
City
ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 916 616 8655
Email
rashidi-m@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakerkish
Street address
24 metery street, East sahely highway, Ahvaz
City
ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 916 616 8655
Fax
+98 916 616 8655
Email
rashidi-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mahbobeh Rashidi
Position
Assistant Professor of Anesthesiology
Latest degree
Ph.D.
Other areas of specialty/work
Anesthesiology
Street address
Azadegan St., 24 meters from Imam Khomeini Hospital
City
ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
0612222922
Email
rashidi-m@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mahbobeh Rashidi
Position
Assistant Professor of Anesthesiology
Latest degree
Ph.D.
Other areas of specialty/work
Anesthesiology
Street address
Azadegan St., 24 meters from Imam Khomeini Hospital
City
ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
0612222922
Email
rashidi-m@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mahbobeh Rashidi
Position
Assistant Professor of Anesthesiology
Latest degree
Ph.D.
Other areas of specialty/work
Anesthesiology
Street address
Azadegan St., 24 meters from Imam Khomeini Hospital
City
ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
0612222922
Email
rashidi-m@ajums.ac.ir

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
Loading...