Comparing the effect of local anesthetic injection site on the quality of intravenous block (bier block) in upper limb
Design
From a package of 70 cards, patients choose one card randomly. The letter A for the control group (Angiocath in the distal ) and the letter B for the intervention group (Angiocath in the proximal ). There are 35 patients in each group.Patients are then assigned to one of the intervention and control groups. Sampling continues in two groups until the number of samples is completed. The sampling method is a double blocking.
Settings and conduct
This study will be conducted in Kowsar Hospital in Sanandaj city. The aim of this study is to compare the effect of local anesthetic injection site on the quality of intravenous block (bier block) in upper limb. The researcher is aware of the type of intervention but the patients are unaware of grouping, therefore the study is single blind.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age 10 to 70 years, no drug addiction, no history of lidocaine allergy
Exclusion Criteria: Drug Addiction, alcohol or painkillers consumption before entering the operating room, allergy to local anesthetics, cardiovascular disease, use of antidepressants, hypertension, seizures
Intervention groups
Intervention group: The angiocath is placed in the proximal part of the forearm. After draining the blood of upper limb, a tourniquet will apply on the arm. 3 mg/kg lidocaine 0.5% is administered through the angiocath and then the angiocath is removed.
Control group: The angiocath is placed in the distal part of the forearm. After draining the blood of upper limb, a tourniquet will apply on the arm. 3 mg/kg lidocaine 0.5% is administered through the angiocath and then the angiocath is removed.
Main outcome variables
Sensory hand block and hand motor block measured 5 minutes after the intervention and at the end of surgery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200126046268N1
Registration date:2020-02-01, 1398/11/12
Registration timing:registered_while_recruiting
Last update:2020-02-01, 1398/11/12
Update count:0
Registration date
2020-02-01, 1398/11/12
Registrant information
Name
Kambiz Javavdzadeh Siahkalrudi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 6631 1231
Email address
kambiz51js@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-26, 1398/10/05
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of local anesthetic injection site on the quality of intravenous block (bier block) in upper limb
Public title
Comparing the effect of local anesthetic injection site on the quality of intravenous block
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 10 to 70 years
No drug addiction
No history of lidocaine allergy
Exclusion criteria:
Drug Addiction
Alcohol or painkillers consumption before entering the operating room
Allergy to local anesthetics,
Cardiovascular disease
Use of antidepressants
Hypertension
Sseizures
Age
From 10 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
From a package of 70 cards, patients choose one card randomly. The letter A for the control group (Angiocath in the distal) and the letter B for the intervention group (Angiocath in the proximal). There are 35 patients in each group. Patients are then assigned to one of the intervention and control groups. Sampling continues in two groups until the number of samples is completed. The sampling method is a double blocking.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are not aware of grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Pasdaran St., Kurdistan University of Medical Sciences, Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Approval date
2019-12-24, 1398/10/03
Ethics committee reference number
IR.MUK.REC.1398.219
Health conditions studied
1
Description of health condition studied
Fracture of forearm
ICD-10 code
S52.0
ICD-10 code description
Fracture of upper end of ulna
2
Description of health condition studied
hand laceration
ICD-10 code
s61.9
ICD-10 code description
Open wound of wrist and hand part, part unspecified
Primary outcomes
1
Description
Hand sensory block
Timepoint
5, 10, 15, 20, 25 and 30 minutes after intervention
Method of measurement
It is measured based on the complete return of sense by clinical examination as touch and stimulation by pin break.Zero- No pain,1- mild pain, 2- Moderate pain, 3- Severe pain, 4- Unbearable pain
2
Description
Hand motor block
Timepoint
Five minutes after intervention and at the end of surgery
Method of measurement
It is scored based on the hand movement status: Zero-Unable to move any part of the limb,1-Able to move fingers, 2-Able to move the limb from the wrist area, 3-Able to move the limb from the elbow area
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The angiocath is placed in the proximal part of the forearm. After draining the blood of upper limb, a tourniquet will apply on the arm. 3 mg/kg lidocaine 0.5% is administered through the angiocath and then the angiocath is removed.
Category
Treatment - Other
2
Description
Control group: The angiocath is placed in the distal part of the forearm. After draining the blood of upper limb, a tourniquet will apply on the arm. 3 mg/kg lidocaine 0.5% is administered through the angiocath and then the angiocath is removed.