Comparison of duration of analgesia in Axillary block with Lidocaine and a mixture of Lidocaine and Granistron in patients requiring lower elbow surgery
Determining the duration of analgesia in axillary block with Lidocaine in comparison with the combination of Lidocaine and Granistron in patients requiring lower elbow surgery
Design
This Clinical trial has control and intervention groups. The intervention group will receive a combination of Lidocaine and Granisetron and the control group will receive Lidocaine only. The trial will be done in the form of a double-blind and randomized study, on 90 patients. Block randomization with block size 4 (With random sequence in the block) and allocation ratio 1:1, will be done. Allocation of patients to intervention and control groups will be parallel.
Settings and conduct
The study was performed in the Orthopedic ward of Razi, Golestan and Imam Khomeini hospitals in Ahvaz for one year (from March 2018 to March 2019).
This Clinical trial has control and intervention groups. The intervention group will receive a combination of Lidocaine and Granisetron and the control group will receive Lidocaine only.
The study was performed in a double blinded form. Participants and health care personnel in the study were blind to the injected drugs.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18-58 years; Being candidate for elbow and under elbow surgery; Level of consciousness above 14 according to Glasgow criteria
Exclusion criteria: Allergy to Lidocaine and Granistron; Taking drugs that interact with Lidocaine and Granistron; Injury or infection at the injection site; History of coagulation diseases
Intervention groups
In the control group, 40 cc of Lidocaine solution was injected after applying the syringe with Epinephrine.
In the intervention group, in addition to Lidocaine solution, 2 mg of Granistron was injected into patients simultaneously.
Main outcome variables
Pain score; Sensory block onset; Motor block onset; Duration of sensory block; Duration of movement block
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200402046916N1
Registration date:2020-11-06, 1399/08/16
Registration timing:retrospective
Last update:2020-11-06, 1399/08/16
Update count:0
Registration date
2020-11-06, 1399/08/16
Registrant information
Name
majid bozar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8770 5402
Email address
majid.bozar91medical@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-24, 1397/10/03
Expected recruitment end date
2019-12-24, 1398/10/03
Actual recruitment start date
2018-12-31, 1397/10/10
Actual recruitment end date
2020-01-05, 1398/10/15
Trial completion date
2020-03-15, 1398/12/25
Scientific title
Comparison of duration of analgesia in Axillary block with Lidocaine and a mixture of Lidocaine and Granistron in patients requiring lower elbow surgery
Public title
Comparison of the effect of Lidocaine and a mixture of Lidocaine and Granisetron on axillary block
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are candidates for elbow and below elbow surgery
Patients between the ages of 18-58 years
Patients whose level of consciousness is above 14 according to the Glasgow standard
Exclusion criteria:
Patients who are allergic to Lidocaine and granisterone
Patients who take drugs that interact with Lidocaine and Granistron
Patients who have a lesion or infection at the injection site
Patients with a history of coagulopathy
Age
From 18 years old to 58 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Method: Simple block randomization with block size 4 and allocation ratio 1:1 (One sample was placed in the intervention group and one sample in the control group until sampling was completed) . Balanced Block Randomization method with block size 4 (With random sequence in the block) and one-to-one allocation was used to place patients in the two groups. The randomization unit was individual.
Codes assigned to patients in both groups were kept in sealed envelopes and provided to the ward secretary. Patients and health care providers did not know about these codes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and health providers will be blinded to the intervention.
Codes assigned to patients in both groups were kept in sealed envelopes and provided to the ward secretary. Patients and health care providers did not know about these codes.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz Jundishapur University of Medical Sciences
Street address
Jundishapur University of Medical Sciences, Golestan highway, Ahwaz
City
Ahwaz
Province
Khouzestan
Postal code
6135853415
Approval date
2019-09-21, 1398/06/30
Ethics committee reference number
IR.AJUMS.REC.1398.462
Health conditions studied
1
Description of health condition studied
Patients require lower elbow surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The onset of sensory block
Timepoint
The onset of sensory block will be measured at 6 and 12 hours after the intervention and also at the time of the first need for analgesia.
Method of measurement
By examining and the PIN PRINK test
2
Description
The onset of motor block
Timepoint
The onset of motor block will be measured at 6 and 12 hours after the intervention and also at the time of the first need for analgesia.
Method of measurement
Examination and the patient's ability in adduction flexion and finger extension
3
Description
The duration of sensory block
Timepoint
The duration of sensory block will be measured at 6 and 12 hours after the intervention and also at the time of the first need for analgesia.
Method of measurement
By examination and PIN PRINK test
4
Description
The duration of motor block
Timepoint
The duration of motor block will be measured at 6 and 12 hours after the intervention and also at the time of the first need for analgesia.
Method of measurement
Examination and the patient's ability in adduction flexion and finger extension
5
Description
Pain score
Timepoint
The pain score will be measured at 6 and 12 hours after the intervention and also at the time of the first need for analgesia.
Method of measurement
By interviewing and the Numeric Rating Scale system
Secondary outcomes
1
Description
Blood pressure
Timepoint
Before the intervention, every 10 minutes during the intervention and 2 and 6 hours after
Method of measurement
Measuring patient's blood pressure by monitoring and a Sphygmomanometer
2
Description
Heart rate
Timepoint
Before the intervention, every 10 minutes during the intervention and 2 and 6 hours after
Method of measurement
Measuring the patient's heart rate by monitoring and pulse counting
3
Description
Respiration
Timepoint
Before the intervention, every 10 minutes during the intervention and 2 and 6 hours after
Method of measurement
Measuring the patient's respiration by monitoring, using the number of breaths per minute
4
Description
Time for taking analgesia
Timepoint
6 and 12 hours after the intervention
Method of measurement
Based on pain scores, analgesic is injected in a pain score of 6 or more.
Intervention groups
1
Description
Intervention group: 5 mg / kg Lidocaine 0.5% is diluted with 0.9% normal saline to 40 cc. After impregnating the syringe with epinephrine, 40 cc of Lidocaine solution and 2 mg of Granistron is injected into patients simultaneously. Axillary block is performed by ultrasonography with linear transducer using short-axis view with in-plane technique. The drugs are manufactured by Caspian Company.
Category
Treatment - Surgery
2
Description
Control group: 5 mg / kg Lidocaine 0.5% is diluted with 0.9% normal saline to 40 cc. After impregnating the syringe with epinephrine, 40 cc of Lidocaine solution is injected. Axillary block is performed by ultrasonography with linear transducer using short-axis view with in-plane technique. The drugs are manufactured by Caspian Company.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomeini hospital
Full name of responsible person
Majid Bozar
Street address
Imam khomeini hospital, Simetri Ave., Ahwaz
City
Ahwaz
Province
Khouzestan
Postal code
6135853415
Phone
+98 61 3222 2922
Email
majid.bozar91medical@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Badawi
Street address
Ahwaz Jundishapur University of Medical Sciences and Health Services, Golestan Boulevard, Ahwaz
City
Ahwaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3222 2922
Email
vakilipardis@yahoo.com
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
Pardis Vakili
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Ahwaz Jundishapur University of Medical Sciences and Health Services, Golestan Boulevard, Ahwaz
City
Ahwaz
Province
Khouzestan
Postal code
6135539345
Phone
+98 61 3222 2922
Email
vakilipardis@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Majid Bozar
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Boulevard, Ahwaz
City
Ahwaz
Province
Khouzestan
Postal code
6135539345
Phone
+98 21 8770 5402
Fax
Email
majid.bozar91medical@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Pardis Vakili
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Ahwaz Jundishapur University of Medical Sciences and Health Services, Golestan Boulevard, Ahwaz
City
Ahwaz
Province
Khouzestan
Postal code
6135539345
Phone
+98 61 3222 2922
Email
vakilipardis@yahoo.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