(1) Objectives: Comparison of efficacy and clinical outcomes of wrist block versus hematoma block anesthesia in order to propose a preferred method for the local anesthesia before treatment of neck of fifth metacarpal fracture. (2) Design: single-center single-blinded randomized clinical trial. (3) Setting and conduct: after enrollment and taking consent forms, patients will be randomized into two groups using random block method and one of anesthetic interventions will be performed. (4) Participants including major eligibility criteria: all patients with the age between 18-75 years old with the diagnosis of the fifth metacarpal fracture. (5) Intervention: all patients receive 3 ml of Midazolam for sedation. While performing nerve blocking, pulse rate, blood pressure and cardiac activities are monitored. In "hematoma block" group, patients receive barbotage injection of lidocaine 2% (3-5 ml) without epinephrine in hematoma site. In "wrist block" group, after detecting landmarks with the help of a nerve locator, following shots will be injected respectively: 5-7 ml of lidocaine 2% without epinephrine in radial and median nerve and 4-5 ml of lidocaine 2% without epinephrine in ulnar nerve. (6) Main outcome measures: primary outcomes include pain intensity and patient satisfaction from anesthesia with the help of visual analogue scale (VAS). Secondary outcomes are angle correction fracture and grip strength of the fifth finger (compared to contra-lateral finger).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201307067274N8
Registration date:2013-07-20, 1392/04/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-07-20, 1392/04/29
Registrant information
Name
Mohsen Mardani Kivi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1321 1470
Email address
mardani@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Guilan University of Medical Sciences
Expected recruitment start date
2013-01-04, 1391/10/15
Expected recruitment end date
2013-07-06, 1392/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of wrist block versus hematoma block anesthesia in the treatment of neck of fifth metacarpal fracture in Rasht Poursina hospital
Public title
Comparison of "hematoma block" versus "wrist block" anesthesia in the treatment of fifth metacarpal fracture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all patients with the age between 18-75 years old with type I or II in ASA classification whom are candidate for the reduction of the fifth metacarpal fracture.
Exclusion criteria: hyper-sensitivity or allergy to local anesthesia; local active infection in the site of injection; coagulopathy disorders; and drug abuse.
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
98
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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, Guilan University of Medical Sciences
Street address
Vice chancellor for research, Guilan University of Medical Sciences, Namjou avenue
City
Rasht
Postal code
Approval date
2013-01-01, 1391/10/12
Ethics committee reference number
1910354601
Health conditions studied
1
Description of health condition studied
Fracture of fifth metacarpal bone
ICD-10 code
S62.3
ICD-10 code description
Fracture of other metacarpal bone
Primary outcomes
1
Description
Pain intensiy
Timepoint
pre- intra- and 5 minute post-reduction
Method of measurement
Visual analogue scale
2
Description
patient satisfaction
Timepoint
during the reduction
Method of measurement
Visual analogue scale
Secondary outcomes
1
Description
Angle correction of the fracture
Timepoint
2 month post treatment
Method of measurement
Goniometer
2
Description
Grip strength of the fifth figer (compared to contra-lateral finger)
Timepoint
2 month post treatment
Method of measurement
Dynamometer
Intervention groups
1
Description
Group A (hematoma block anesthesia): barbotage injection of the lidocaine 2% (3-5 ml) without epinephrine in hematoma site.
Category
Treatment - Other
2
Description
Group B (wrist block anesthesia): after detecting landmarks with the help of a nerve locator, following shots will be injected respectively: 5-7 ml of lidocaine 2% without epinephrine in radial and median nerve, 4-5 ml of lidocaine 2% without epinephrine in ulnar nerve.