Comparison of Forearm ultrasound-guided nerve blocks vs landmark-based wrist blocks outcomes For palm and fingers surgery. A Randomized clinical trial
Design
A randomized clinical trial without control group, with parallel groups, without blindness that, 70 patients randomly divided into two groups of 35 subjects with block sizes of 4 and 6.
Settings and conduct
The population of this study was aged 18-65 years old who referred to Ayatollah Rouhani Hospital in Babol. Patients are randomly divided into two Intervention groups with a table of random numbers by computer. Intervention group1: Radial and ulnar median nerve، each one block with 4 ml lidocaine 1% total 12 ml adhering to Landmark.
Intervention group2: Radial and ulnar median nerve، each one block with 4 ml lidocaine 1% total 12 ml under ultrasound guide.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: 65-18 years old, Isolated hand trauma, Signing consent to participate in the study.
Exclusion Criteria: Coagulation disorders, Spinal deformities, Smoking
Intervention groups
Intervention group1: Radial and ulnar median nerve، each one block with 4 ml lidocaine 1% total 12 ml adhering to Landmark.
Intervention group2: Radial and ulnar median nerve، each one block with 4 ml lidocaine 1% total 12 ml under ultrasound guide.
Main outcome variables
Analgesia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191026045245N1
Registration date:2019-12-08, 1398/09/17
Registration timing:registered_while_recruiting
Last update:2019-12-08, 1398/09/17
Update count:0
Registration date
2019-12-08, 1398/09/17
Registrant information
Name
Mohsen Daghmehchi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3233 8301
Email address
m.daghmehchi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-26, 1398/04/05
Expected recruitment end date
2020-06-25, 1399/04/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Forearm ultrasound-guided nerve blocks vs landmark-based wrist blocks outcomes For palm and fingers surgery. A Randomized clinical trial
Public title
Wrist nerve blocks For palm and fingers surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
65-18 years old
Isolated hand trauma
Signing consent to participate in the study
Exclusion criteria:
Coagulation disorders
Spinal deformities
Smoking
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The patients randomly divided into two groups of 35 subjects with four and six blocks and an allocation ratio of 1: 1.The participants allocation sequence in two groups performed with a Randomizer software.Opaque sealed sequentially numbered envelops used for allocation concealment.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University Of Medical Sciences
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Approval date
2019-06-25, 1398/04/04
Ethics committee reference number
IR.MUBABOL.HRI.REC.1398.204
Health conditions studied
1
Description of health condition studied
Palm and fingers
ICD-10 code
S60
ICD-10 code description
Superficial injury of wrist, hand and fingers
Primary outcomes
1
Description
Analgesia
Timepoint
5, 10,15, 20 minutes after each block
Method of measurement
Visual Analogue Scale, Visual, questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1:Radial and ulnar median nerve، each one block with 4 ml lidocaine 1% total 12 ml adhering to Landmark
Category
Treatment - Surgery
2
Description
Intervention group2:Radial and ulnar median nerve، each one block with 4 ml lidocaine 1% total 12 ml under ultrasound guide
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital
Full name of responsible person
Mohsen Daghmehchi
Street address
Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3233 8301
Email
dr.amiri_nima@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Vice-chancellor Of Research, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3219 7667
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?