Protocol summary

Study aim
The study hypothesis is that Wide awake local anaesthesia no tourniquet technique (WALANT) and forearm BIER block are safe, inexpensive and suitable alternative to the conventional anesthesia techniques for hand surgeries.
Design
Two arm parallel group randomised trial design of 86 patients, enrolled between june 2018 and september 2018
Settings and conduct
This study will be performed on 86 ASA class I-III patients between the ages of 20--65 years who undergoing hand and wrist surgeries. After obtaining of an informed consent, patients will be allocated to two groups by stratified random sampling.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:20--65 years old patients undergoing hand surgeries Exclusion Criteria:psychologic patients, addiction, history of allergy to local anesthethcs, epilepsy, history of peripheral vascular disease, coagulopathy, pregnancy, open wound in operation site
Intervention groups
. In the WALANT group, 20 ml solution including lidocaine 1% and einephrine( 5Mg/ml ) and sodium bicarbonate (50mg/2ml) will be injected into operation site. Injection will be done by a 27_gauge needle. In the bier block group(IRIV), a 22G cannula will be secured on the dorsum of the operative hand. The single cuff tourniquet will be then placed around the forearm and inflated to a pressure of 100 mmHg above the patient’s systolic blood pressure and minimum of 250 mmHg. IRIV will be achieved with 25 lidocaine 0.5 % plus fentanyl 50 Mg. The sensory block will be evaluated with pinprick testing every 30 s until the start of surgery.
Main outcome variables
Determination of WALANT effects on analgesia, complications, patient satisfaction, surgery site bleeding, need to additional IV sedation and analgesics and comparison them with forearm BIER block group.

General information

Reason for update
Acronym
WALANT-BEER
IRCT registration information
IRCT registration number: IRCT20180325039148N2
Registration date: 2018-06-09, 1397/03/19
Registration timing: registered_while_recruiting

Last update: 2018-06-09, 1397/03/19
Update count: 0
Registration date
2018-06-09, 1397/03/19
Registrant information
Name
Saeed Jalili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3313 0001
Email address
jalilis45@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of wide awake local anesthetesia(WALANT) and bier block on hand surgery
Public title
Effect of regional anesthesia in Hand surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
20-65 Years old Hand surgery
Exclusion criteria:
Psychologic disease Pregnancy Raynod disease Peripheral vascular disease Addiction Open wound Allergy to local anesthetics Epilepsy Coagulation disease
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 86
Randomization (investigator's opinion)
Randomized
Randomization description
stratified randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients,Analysers of Data
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Gavazanng Blvd., Moosavi Hospital
City
Zanjan
Province
Zanjan
Postal code
4513956183
Approval date
2018-03-06, 1396/12/15
Ethics committee reference number
IR.ZUMS.REC.1396.310

Health conditions studied

1

Description of health condition studied
Carapal Tunnel Syndrome
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Determination of of local anesthesia and analgesia in hand surgery
Timepoint
Beginnig of surgery_During of surgery_Recovery unit
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
1st Intervention group : Under local anesthesia ,awake and without tourniquet (WALANT) ,20 ml solution including lidocaine 1% and einephrine( 5Mg/ml ) and sodium bicarbonate (50mg/2ml) will be injected into operation site.Injection will be done by a 27_gauge needle.
Category
Treatment - Surgery

2

Description
2nd Intervention group:A 22G cannula will be secured on the dorsum of the operative hand, after which, limb exsanguination will be achieved with an esmarch bandage . The single cuff tourniquet will be then placed around the forearm and inflated to a pressure of 100 mmHg above the patient’s systolic blood pressure and to a minimum of 250 mmHg. Circulatory isolation of the operative arm was confirmed by absence of radial .IRIV will be achieved with 25 lidocaine 0.5 % plus fentanyl 50 Mg.The sensory block will be evaluated with pinprick testing every 30 s until the start of surgery.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Mousavi Hospital
Full name of responsible person
Saeed Jalili
Street address
Gavazang Blvd., Mosavi Hospital
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Fax
+98 24 3313 1203
Email
jalilis45@zums.ac.ir
Web page address
http://zums.ac.ir/index.php?slc_lang=fa&sid=19

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Shoghli Alireza
Street address
Gavazang Blvd., Mousavi hospital
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Fax
+98 24 3313 1203
Email
jalilis45@zums.ac.ir
Web page address
http://zums.ac.ir/index.php?slc_lang=fa&sid=19
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Jalili Saeed
Position
Consultant, Professor, Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Gavazang Blvd.,Mousavi hospital
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Fax
+98 24 3313 1203
Email
jalilis45@zums.ac.ir
Web page address
http://zums.ac.ir/index.php?slc_lang=fa&sid=19

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Jalili Saeed
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Gavazang Blvd., Mousavi hospital
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Fax
+98 24 3313 1203
Email
jalilis45@zums.ac.ir
Web page address
http://zums.ac.ir/index.php?slc_lang=fa&sid=19

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Saeed Jalili
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Gavazang Blvd., Moosavi hospital
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0001
Fax
+98 24 3313 1203
Email
jalilis@ymail.com
Web page address
http://zums.ac.ir/index.php?slc_lang=fa&sid=19

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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not 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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