Protocol summary

Study aim
Determining the effect of axillary block + subcutaneous lidocaine infiltration on reducing tourniquet pain in orthopedic surgeries of the forearm, wrist or hand with using tourniquet
Design
A randomized, double-blinded, controlled clinical trial with a parallel group enrolled 78 patients. Random number table is used for randomization.
Settings and conduct
This study is performed in Akhtar Hospital . The severity of the tourniquet pain is measured immediately after inflating the tourniquet and then every 15 minutes with the Verbal Rating Scale. The first complaint of tourniquet pain is recorded during surgery. If the patient complains of tourniquet pain or VRS>1, intravenous fentanyl and, if necessary, ketamine is injected. If the pain persists, propofol is infused and if there is no response, general anesthesia is performed. Doses of fentanyl, ketamine, and propofol are also recorded.Participants, researchers and outcome assessors are unaware of the allocation of study groups.
Participants/Inclusion and exclusion criteria
78 patients aged 15 years and older ASA class Ⅰ- Ⅲ scheduled for orthopedic surgery of the forearm, wrist or hand under the sono-guided axillary block with the use of tourniquets are included. Cases of rejection, lidocaine hypersensitivity, coagulation disorders, opium addiction, non-cooperation, block site infection, BMI≥30, DVT, sickle cell anemia, tourniquet inflation time of less than 30 minutes are excluded.
Intervention groups
Patients are randomly divided into two equal groups of axillary block alone and axillary block + subcutaneous infiltration of lidocaine. In the axillary block alone group, 5 ml of normal saline and in the Intervention group, 5 ml of 1.5% lidocaine are injected subcutaneously in the upper inner part of the upper arm.
Main outcome variables
The severity of tourniquet pain and the total amount of administered fentanyl, ketamine and propofol.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20131108015322N6
Registration date: 2022-02-06, 1400/11/17
Registration timing: registered_while_recruiting

Last update: 2022-02-06, 1400/11/17
Update count: 0
Registration date
2022-02-06, 1400/11/17
Registrant information
Name
Shideh Dabir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2595
Email address
sdabir@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-10, 1400/10/20
Expected recruitment end date
2022-03-16, 1400/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of axillary block alone versus axillary block + subcutaneous injection of local anesthetic on tourniquet pain relief in upper limb orthopedic surgeries
Public title
The effect of axillary block with subcutaneous injection of local anesthetic on tourniquet pain relief
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
ASA class I- III Patient acceptance Unilateral orthopedic surgery of forearm or wrist or hand Tourniquet inflation time more than 30 minutes Patients 15 years and older
Exclusion criteria:
ASA class more than III Patient refusal Allergy to lidocaine Age less than 15 years Coagulopathy Opium addiction Lack of patient cooperation Infection at block site BMI≥30 Patients with DVT Patients with sickle cell anemia Tourniquet inflation time less than 30 minutes
Age
From 15 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 78
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are randomly assigned to 1 of 2 groups following simple randomization by using a random numbers table. The allocation sequence is concealed in sealed envelopes. In the operating room, the envelope is opened by an investigator with no clinical involvement in the trial.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and assignment of patients in each group is done by a person not involved in the study. The investigators and persons who measures the outcome in two groups are also kept blinded.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Building No. 2, 5th floor, Office in Research Affairs, shahid Beheshti University of Medical sciences, Shahid Chamran Highway, Yemen St., Arabi St., next to Taleghani Hospital
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2021-10-12, 1400/07/20
Ethics committee reference number
IR.SBMU.MSP.REC.1400.476

Health conditions studied

1

Description of health condition studied
Prevention of upper arm tourniquet pain during orthopedic surgery performed under axillary brachial plexus block.
ICD-10 code
G89
ICD-10 code description
Pain, not elsewhere classified

Primary outcomes

1

Description
Intraoperative severity of tourniquet pain
Timepoint
Immediately after inflating the tourniquet and then every 15 minutes during operation
Method of measurement
Verbal Rating Scale 0-4

Secondary outcomes

1

Description
Total intraoperative dose of fentanyl and ketamine and propofol
Timepoint
From the time of inflating the tourniquet to the end of the operation
Method of measurement
Calculating the sum of injected doses

2

Description
Duration of tourniquet inflation
Timepoint
From inflating the tourniquet to deflating it during surgery
Method of measurement
The time interval between inflation and deflation of tourniquet is measured in minutes.

Intervention groups

1

Description
Control group: axillary block + subcutaneous infiltration of 5 ml of normal saline in the upper inner part of the upper arm
Category
Treatment - Other

2

Description
Intervention group: axillary block + subcutaneous infiltration of 5 ml of lidocaine 1.5 % in the upper inner part of the upper arm
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Akhtar Hospital
Full name of responsible person
Faramarz Mosaffa
Street address
Akhtar Hospital, Shariati Ave., Pole- Rumi St., Sharifimanesh St., Azar dead end
City
Tehran
Province
Tehran
Postal code
1964714953
Phone
+98 21 2664 0307
Email
faramarzmosaff@yahoo.com
Web page address
http://amc.sbmu.ac.ir/#

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Dabbagh
Street address
Fourth floor, Anesthesiology Research Center, Taleghani Hospital, Arabi St., Yemen St., Velenjak
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2303 1550
Email
alidabbagh@sbmu.ac.ir
Web page address
https://arc.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
Shideh Dabir
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
2nd floor, Department of Anesthesiology, Taleghani Hospital, Arabi St., Yaman St. Velenjak
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2303 1550
Email
shdabir@yahoo.com
Web page address
http://taleghani.sbmu.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shideh Dabir
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
2nd floor, Department of Anesthesiology, Taleghani Hospital, Arabi St., Yaman St. Velenjak
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2595
Email
shdabir@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shideh Dabir
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
2nd floor, Department of Anesthesiology, Taleghani Hospital, Arabi St., Yaman St. Velenjak
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2595
Email
shdabir@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
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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