Determining the efficacy of interscalene block without cervical plexus block for anesthesia in clavicle surgery
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 120 patients. Simple randomization will be used in the form of shuffling cards.
Settings and conduct
After the approval of the ethics committee of Shahid Beheshti University of Medical Sciences and obtaining the patient's consent, 120 patients who meet the inclusion criteria will be entered into the study. Patients will be divided by a simple randomization method into one of the groups of interscalene block alone or along with superficial cervical plexus block in the block room of Akhtar Hospital. The people responsible for creating a random sequence from the research team will not be responsible for examining the dependent variable. The data analyst will not know about the coding of the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients weigh less than 80 kg
Age between 18 to 60 years
Normal neuromotor and sensory function
Consent to the operation and performing the anesthetic procedure
Non-entry Criteria:
Contraindications of nerve blocks (Local infection, coagulopathy, and sensitivity to anesthetics)
Persistent treatment or abuse of narcotics, alcohol, or other addictive drugs
Mental disorders, restrictive or obstructive pulmonary diseases
Pregnancy
Consumption of beta-blockers or a heart rate below 50
Intervention groups
Control group: Patients with primary clavicle fracture requiring fixation surgery who undergoing interscalene nerve block and superficial cervical block.
Intervention group: Patients with primary clavicle fracture requiring fixation surgery who undergoing interscalene nerve block alone.
Main outcome variables
Need to induce general anesthesia for surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230204057318N1
Registration date:2023-02-19, 1401/11/30
Registration timing:prospective
Last update:2023-02-19, 1401/11/30
Update count:0
Registration date
2023-02-19, 1401/11/30
Registrant information
Name
Alireza Shakeri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7343 0000
Email address
dr.alirezashakeri@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-21, 1402/01/01
Expected recruitment end date
2023-06-21, 1402/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy comparison between interscalene block with & without superficial cervical block for anesthesia in clavicle surgery
Public title
Interscalene block with & without superficial cervical block
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients weights less than 80 kg
Age between 18 to 60 years
Normal neuromotor and sensory functions
Consent to the operation and performing the anesthetic procedure
Exclusion criteria:
Persistent treatment or abuse of narcotics, alcohol or other addictive drugs
Contraindications of nerve blocks (Local infection, coagulopathy and sensitivity to anesthetics)
Presence of mental disorders, restrictive or obstructive pulmonary diseases
Pregnancy
Consuming beta blockers or heart rate below 50
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Creating a random sequence using a simple randomization method using 120 cards (60 cards for each group) that are placed inside opaque sealed envelopes and will be shuffled by the patients before choosing.
Blinding (investigator's opinion)
Double blinded
Blinding description
The people responsible for creating a random sequence from the research team will not be responsible for examining the dependent variable. (The study will be blind.)
Also, the data analyst will not know about the coding of the examined groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Yaman st., Shahid Chamran Hwy.
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-01-25, 1401/11/05
Ethics committee reference number
IR.SBMU.MSP.REC.1401.526
Health conditions studied
1
Description of health condition studied
Clavicle fracture surgery
ICD-10 code
S42.0
ICD-10 code description
Fracture of clavicle
Primary outcomes
1
Description
Need to induce general anesthesia for surgery
Timepoint
During surgery
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Postoperative pain score in the recovery room
Timepoint
From the entrance to the recovery room until discharge time from the recovery room
Method of measurement
Visual analogue scale
2
Description
The onset of sensory block
Timepoint
From the end of the nerve block procedure until the beginning of surgery
Method of measurement
Chronometer (Minute)
3
Description
The amount of narcotics used in recovery room
Timepoint
From the entrance to the recovery room until discharge time from the recovery room
Method of measurement
Observation
4
Description
Need for sedation during surgery
Timepoint
During surgery
Method of measurement
Observation
Intervention groups
1
Description
Intervention group: After placing the patient in a suitable position, the interscalene block will be performed by experienced anesthesiologists, all of whom are trained in regional anesthesia. To perform each interscalene block, 20 ml of 1.5% lidocaine (Caspin Co.) along with 1 ml of 8.4% bicarbonate (Caspin Co.) and 1:200,000 epinephrine (Daroupash Co.), plus 4 ml of 0.5% bupivacaine (AstraZeneca Co.) will be used. An ultrasonic guide (S-Nerve Sonosite) with a linear probe of 6-15 MHz will be used to perform the block.
Category
Treatment - Surgery
2
Description
Control group: in the control group, in addition to performing the interscalene block method as described, superficial cervical plexus block with 10 ml of 1.5% lidocaine (Caspin Co.) along with 1 ml of 8.4% bicarbonate (Caspin Co.) and 1:200,000 epinephrine (Daroupakhsh Co.) plus 2 ml of 0.5% bupivacaine (AstraZeneca Co.) will be used. This block will be performed under ultrasonic guidance (S-Nerve Sonosite) with a 6-15 MHz linear probe.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Akhtar Hospital
Full name of responsible person
Alireza Shakeri
Street address
Akhtar Hospital, Azar St. Sharifi Avenue, Pole-Romi Avenue, Shariati
City
Tehran
Province
Tehran
Postal code
1964714953
Phone
+98 21 2200 1072
Email
dr.alirezashakeri@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Next to Taleghani Hospital, Yemen Street, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2243 9331
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afsaneh Habibi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Yemen Street, Velenjak, Chamran Highway,
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2990 8040
Email
a.habibi85@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afsaneh Habibi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Yemen Street, Velenjak, Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2990 8040
Email
a.habibi85@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afsaneh Habibi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Yemen Street, Velenjak, Chamran Highway,
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2990 8040
Fax
Email
a.habibi85@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
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