The quality of local anesthetic block with sufentanil in orthopedic patients
Design
This study is a clinical trial in which patients are divided into two groups of 30 each Patients in group I receive lidocaine with normal saline, and patients in group II receive sufentanil in addition to lidocaine and normal saline.
Settings and conduct
This study will be conducted at Shahid Mohammadi Hospital in Bandar Abbas. Written informed consent was obtained from all patients and after entering the operating room standard monitoring including NIBP (non-invasive blood pressure cuff), pulse oximetry and ECG were attached to them, and all of their baseline vital signs were measured. Afterwards, we placed a double-cuff tourniquet on the arm where was surgery target and a 22-gauge IV angiocatheter was used to inject the medication therein. Then, through holding up the arm for 3 min and with moving around elastic band from fingertip to surgery target, the veins were pumped out. Next, the blood pressure cuff (proximal region) was inflated by a minimal pressure of 100 mmHg higher than systolic pressure (at least 250 mmHg). The elastic band was removed and the lack of blood flow, oximetry pulse signal and radial beats were confirmed.Then,The drug is injected into the target groups.
Participants/Inclusion and exclusion criteria
A randomized, double-blind, controlled clinical trial
Intervention groups
Group 1 will be received 3mg/kg lidocaine 0.5% diluted by normal saline 0.9% (totally 40 ml solution)
Group 2, 3mg/kg lidocaine 0.5% diluted by normal saline 0.9% + 4cc sufentanil (totally 40 ml solution)
Main outcome variables
Assessment of sensory and motor block, hemodynamic variables, Assessment of tourniquet pain and side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110313006044N3
Registration date:2020-03-10, 1398/12/20
Registration timing:prospective
Last update:2020-03-10, 1398/12/20
Update count:0
Registration date
2020-03-10, 1398/12/20
Registrant information
Name
Hashem Jarineshin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3334 5009
Email address
hjarineshin@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2020-05-19, 1399/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Efficacy of Sufentanil-Lidocaine Compound as the Intravenous Regional Anesthetic in Elective Orthopedic Patients
Public title
The effect of sufentanil on intravenous anesthesia in orthopedic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All Candidates aged 18-50 years for- forearm surgery with ASA I,II classes
Exclusion criteria:
Patients who are allergic to sufentanil or topical anesthetic.
Patients with a history of liver or kidney disease.
Patients who have sickle cell anemia or convulsion.
Patients with Raynaud syndrome and neuropathy.
Patients who have uncontrolled hypertension and opioid addiction.
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The sample was randomly divided into two groups of 30 patients. Each envelope containing one of the two labels A and B represented one of the intervention groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to eliminate bias from patient's awareness or anesthesia assistant and its possible impact on the outcome of the study, the study will be conducted in a double-blind condition. After receiving written informed consent from patients, local anesthesia was done by giving the same drugs and same volume to the anesthesiologist, then relevant information was recorded in the questionnaire by the anesthesiologist who was not aware of the injection of the drugs. It is obvious that the patient and the anesthesiologist were not aware of the type of drug being administered.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hormozgan University of Medical Sciences
Street address
Jomhuri Blvd, Shahid Mohammadi Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Approval date
2015-10-07, 1394/07/15
Ethics committee reference number
HUMS.REC.1394.72
Health conditions studied
1
Description of health condition studied
Forearm surgery
ICD-10 code
S52.9
ICD-10 code description
Unspecified fracture of forearm
Primary outcomes
1
Description
Tourniquet pain
Timepoint
Pain intensity measurement at baseline (before intervention) and 5,10,15 and 20 min after injection
Method of measurement
Patients' severity of pain is based on the Visual Analogues Scale
2
Description
Quality of local anesthesia
Timepoint
During Surgery
Method of measurement
Numerical scale(1-4) of patient satisfaction
Secondary outcomes
1
Description
The evaluation of sensory block
Timepoint
During surgery every 10 minutes
Method of measurement
22-gauge needle on palm in hypothenar (ulna nerve) and thenar (median nerve) eminences and back of the upper arm between thumb and forefinger (radial nerve).
2
Description
The evaluation of motor block
Timepoint
During surgery every 10 minutes
Method of measurement
Observation
3
Description
Side effects such as nausea, vomiting, seizures, hypotension, bradycardia, and itching
Timepoint
During and after surgery
Method of measurement
Observation
Intervention groups
1
Description
Intervention group: The first group 3 mg/kg lidocaine 0.5% diluted with 0.9% normal saline at a total volume of 40 cc.
Category
Treatment - Drugs
2
Description
Intervention group: The second group 3 mg/kg lidocaine 0.5% diluted with 0.9% normal saline + 4 cc sufentanil at a total volume of 40 cc
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mohammadi Hospital
Full name of responsible person
Hashem Jarineshin
Street address
Jomhuri Blvd, Shahid Mohammadi Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 76 3334 5009
Email
hjarineshin@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Abdul Azim Nejati Zadeh
Street address
Deputy of research and technology, East Side, Bandar Abbas Hospital, Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 71 3333 5794
Email
azimnejate @yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas University of Medical Sciences
Proportion provided by this source
50
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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Hashem Jarineshin
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Jomhuri Blvd, Shahid Mohammadi Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 76 3334 5009
Email
hjarineshin@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Hashem Jarineshin
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Jomhuri Blvd, Shahid Mohammadi Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 76 3334 5009
Email
hjarineshin@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Hashem Jarineshin
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Jomhuri Blvd, Shahid Mohammadi Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 76 3334 5009
Email
hjarineshin@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the main outcome can be shared.
When the data will become available and for how long
Starting the post-access period of the paper was accepted
To whom data/document is available
All researchers
Under which criteria data/document could be used
Using data to complete clinical studies
From where data/document is obtainable
Shahid Mohammadi Hospital
What processes are involved for a request to access data/document
By reviewing the researcher's request and providing sufficient documentation of your research and the reason for using the data, it will be possible.