Comparison of dexmedetomidine and ketamine in serratus anterior plate block in pain control of patients after thoracotomy surgery. A randomized clinical trial study
Reduction of hospitalization and treatment costs in ICU
Design
Allocation of patients into two groups of 37 people will be done by a simple random method and through sealed envelopes. They are randomly assigned to one of two groups: ketamine-ropivacaine (RK) and dexmedetomidine-ropivacaine (RD)
Settings and conduct
After obtaining the study ethics code and registering the study as an RCT, all patients referred to the Imam Khomeini Medical Training Center of Ahvaz who undergo thoracotomy surgery are evaluated in terms of the conditions of entering and exiting the study.
Participants/Inclusion and exclusion criteria
Dissatisfaction to attend the study
Injection site infection
Allergy to local anesthetic
BMI above 40
History of drug or alcohol abuse
Pregnancy or breastfeeding
History of coagulation problems or use of anticoagulants
History of HF and heart conduction disorders (except 1th-degree block) and AF
Suffering from hepatorenal diseases
History of neuropsychological diseases
Intervention groups
Ketamine-ropivacaine
dexmedetomidine-ropivacaine
Main outcome variables
Patient's pain using Verbal Analog Scale
(VAS), which is a subjective criterion for evaluating pain in patients and widely used in medical studies, is performed.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190417043295N3
Registration date:2023-01-03, 1401/10/13
Registration timing:registered_while_recruiting
Last update:2023-01-03, 1401/10/13
Update count:0
Registration date
2023-01-03, 1401/10/13
Registrant information
Name
Reza Baghbanian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 0168
Email address
baghbanian-r@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-11, 1401/09/20
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of dexmedetomidine and ketamine in serratus anterior plate block in pain control of patients after thoracotomy surgery. A randomized clinical trial study
Public title
Comparison of dexmedetomidine and ketamine in serratus anterior plane block in pain control after thoracotomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Physical condition with ASA class 1 and 2
Age 18 to 60 years
Exclusion criteria:
Dissatisfaction to attend the study
Injection site infection
Allergy to local anesthetic
BMI above 40
History of drug or alcohol abuse
Pregnancy or breastfeeding
History of coagulation problems or use of anticoagulants
History of HF and heart conduction disorders (except 1th degree block) and AF
Suffering from hepatorenal diseases
History of neuropsychological diseases
Age
From 18 years old to 60 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Thoracotomy operations are usually performed within several months of sampling, and the required 74 patients will not undergo such an operation in the hospital at the same time. 74 sealed envelopes with cards inside that include 37 cards number 1 and 37 cards number 2 are prepared and each patient is randomly selected for the group in which they will be studied.
Description of groups:
1-Prescription of ropivacaine and dexmedetomidine
2- Prescription of ropivacaine and ketamine
Blinding (investigator's opinion)
Not blinded
Blinding description
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
Iran,Golestan Ave, Golestan Hospital
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2022-11-01, 1401/08/10
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1401.117
Health conditions studied
1
Description of health condition studied
Pain control of patients after thoracotomy surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Verbal Analog Scale (VAS)
Timepoint
This criterion is rated as a continuous line, which is divided from 0-10 into equal intervals before inversion, one hour, six hours, twelve hours, twenty-four hours, and forty-eight hours later, and the patient uses it to reduce pain. He grades himself
Method of measurement
Based on the patient's self-rating of pain intensity
Secondary outcomes
1
Description
O2 Saturation
Timepoint
Before intervention , one hour, six hours, twelve hours, twenty four hours and forty eight
Method of measurement
Based on measurement with pulse oximetry
2
Description
Mean arterial pressure
Timepoint
Based on measurement
Method of measurement
mmHg
3
Description
heart beat
Timepoint
Based on measurement
Method of measurement
this The information includes body temperature, blood pressure, heart rate, breathing rate, as well as blood oxygen saturation and amount CO2 is the end of exhalation. Patient's pain using verbal pain index (Verbal Analog Scale); that It is a subjective criterion for evaluating pain in patients and is widely used in medical studies
4
Description
Duration of surgery
Timepoint
Based on measurement
Method of measurement
The duration of the surgery is recorded at the end of the surgery and transferred to the patient's checklist.
Intervention groups
1
Description
First, the patient is placed in the supine or lateral decubitus position and a high-frequency linear transducer is used sagittally or transversely on the midaxillary line. The transducer is slowly directed towards the back of the body to reveal the space between the latissimus dorsi and serratus anterior muscles, ribs and pleura. After prep and drape, the needle (22 gauge model Dr. J-602 made by Dr. Japan) is used (in-plane or out of plane). After aspiration, half of the surface solution is injected into the serratus anterior muscle in the depth of the latissimus dorsi muscle and the rest (the other half) in the depth of the serratus anterior muscle, and after the needle is removed, it is placed under pressure and an ice pack. In the first group, ketamine 0.5 mg/kg and 0.4 cc/kg ropivacaine 0.25% and in the second group, in addition to 0.4 cc/kg ropivacaine 0.25%, dexmedetomidine 0.5 macrogram/kilogram was added.
Category
Treatment - Drugs
2
Description
The second intervention group: the second group, dexmedtomidine 0.5 mcg/kg and 0.4 cc/kg rupivacaine 0.25%
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
2
Recruitment center
Name of recruitment center
Ahvaz Golestan Hospital
Full name of responsible person
Mahbobeh Rashidi
Street address
Golestan Hospital, Ahvaz- Golestan
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
Email
rashidi-m@ajums.ac.ir
Grant name
Pain and anesthesia research center
Grant code / Reference number
PAIN-0115
Is the source of funding the same sponsor organization/entity?
No
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
Specialist
Other areas of specialty/work
Anesthesiology
Street address
24 metery street, East sahely highway, Ahvaz
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
Specialist
Other areas of specialty/work
Anesthesiology
Street address
24 metery street, East sahely highway, Ahvaz
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
24 metery street, East sahely highway, Ahvaz
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