The effect of dexmedetomidine injection in epidural block on analgesia in patients after thoracotomy
Design
This study is a double-blind, randomized, controlled clinical trial on 40 patients. Block randomization method is used for randomization.
Settings and conduct
First, the patient is placed in a sitting position, and an18 gauge needle is inserted using the paramedian method and lidocaine will be injected through the needle. Then an epidural catheter is inserted through the needle. For the intervention group, ropivacaine and dexmedetomidine as a bolus are injected through an epidural catheter before surgical incision and then as an epidural infusion will be continued during surgery and up to 48 hours after surgery. For the control group, rupivacaine is injected through an epidural catheter before surgical incision and continues with an infusion of rupivacaine during surgery and up to 48 hours after surgery. This study is performed in Rasoul Akram Hospital in Tehran.In this study, people who are responsible for patient care and analysis of statistical data do not know about the treatment process and study groups, and information is provided to them in groups A and B.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Candidate patients for thoracotomy surgery, ASA physical class < or = class III
Exclusion criteria: Treatment with alpha adrenergic antagonists Contraindications to epidural catheter placement
Patients who do not have the possibility of extubation after surgery
Intervention groups
Intervention group: Patients who are candidates for thoracotomy surgery who use dexmedetomidine with rupivacaine for analgesia for epidural anesthesia.
Control group: Patients who are candidates for thoracotomy surgery who use rupivacaine for epidural anesthesia.
Main outcome variables
Patient pain, adequate respiratory ventilation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181104041550N1
Registration date:2022-01-13, 1400/10/23
Registration timing:registered_while_recruiting
Last update:2022-01-13, 1400/10/23
Update count:0
Registration date
2022-01-13, 1400/10/23
Registrant information
Name
SaeidReza Entezary
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6651 5758
Email address
entezary.sr@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-06-20, 1401/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of dexmedetomidine injection in epidural block on analgesia in patients after thoracotomy.
Public title
The effect of dexmedetomidine injection on analgesia in patients after chest surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate patients for thoracotomy surgery
ASA physical class < or = class III
Exclusion criteria:
Treatment with alpha adrenergic antagonists
Contraindications to epidural catheter placement
Patients who do not have the possibility of extubation after surgery
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we use the block randomization method so that after selecting patients according to the inclusion and exclusion criteria by selecting numbers from the table of random numbers and adapting to the blocks, patients are divided into study groups.To randomize the two treatment methods, we create 4 blocks in six different states, then select a number using the table of numbers, and determine the study groups by matching the numbers with the blocks.
For example, if the first digit of our number is 1 to 6, select a block and the division is done, but if, for example, our number is 94071, the digit 9 is not valid and we select the next digit.
Here, based on the block, we divide 4 people into groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, people who are responsible for patient care and analysis of statistical data do not know about the treatment process and study groups, and information is provided to them in groups A and B.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
8874113911
Approval date
2021-01-18, 1399/10/29
Ethics committee reference number
IR.IUMS.FMD.REC.1399.595
Health conditions studied
1
Description of health condition studied
Chest surgery
ICD-10 code
G89.22
ICD-10 code description
Chronic post-thoracotomy pain
Primary outcomes
1
Description
Patients pain rate
Timepoint
Up to 48 hours after surgery
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Adequate respiratory ventilation
Timepoint
Up to 48 hours after surgery
Method of measurement
Observation
Intervention groups
1
Description
Intervention group: First, one liter of normal saline (made by Samen Pharmaceutical Company) is injected intravenously for the patient, then the patient is placed in a sitting position, and under sterile conditions, thoracic vertebrae seven to ten are identified. An 18 gauge needle is inserted using the paramedian method and 3 cc of lidocaine (made by Samen Pharmaceutical Company) will be injected through the needle. Then an epidural catheter is inserted through the needle.Then 6 mg of ropivacaine 0.1% (made by Royan Daru Pharmaceutical Company) and 1 mg of dexmedetomidine (made by Mehrdaro Pharmaceutical Company)as a bolus are injected through an epidural catheter before surgical incision and then as an epidural infusion (4 mg of ropivacaine 0.1% and 1 mg dexmedetomidine) will be continued during surgery and up to 48 hours after surgery.
Category
Treatment - Drugs
2
Description
Control group: First, one liter of normal saline (made by Samen Pharmaceutical Company) is injected intravenously for the patient, then the patient is placed in a sitting position, and under sterile conditions, thoracic vertebrae seven to ten are identified. An 18 gauge needle is inserted using the paramedian method and 3 cc of lidocaine (made by Samen Pharmaceutical Company) will be injected through the needle. Then an epidural catheter is inserted through the needle.Then 6 ml of rupivacaine 0.1%(made by Royan Daru Pharmaceutical Company) is injected through an epidural catheter before surgical incision and continues with an infusion of 4 mg of rupivacaine 0.1% during surgery and up to 48 hours after surgery.