This is a randomized clinical trial, non-blinded study that has been designed for 100 patients with traumatic finger injuries who need some procedures on their fingers. It sets up at Imam Khomeini and Sina hospitals during 1394 until 1395. One hundred patients with traumatic finger injury requiring digital nerve block are randomly divided to two control and case groups. In the case group, injured fingers are thoroughly covered by ice for 6 minutes following by needle insertion. The procedure is conducted with no ice application in the control group. Afterwards, the injured finger is anesthetized using Lidocaine. Numeric Rating Scale (NRS) is records after ice application, during needling and the time of injection. This scale has range of 0-10. Results will be published in mean and standard deviation. In addition, satisfaction questionnaire will be filled after procedure completion.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017010731807N1
Registration date:2017-09-23, 1396/07/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-23, 1396/07/01
Registrant information
Name
Fatemeh Rasooli
Name of organization / entity
Sina Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8500
Email address
f-rasooli@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-02-19, 1394/11/30
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of comparison of needle stick pain due to digital block in finger traumatic patients with and without using an ice in site of damage.
Public title
Ice effect on pain reduction due to needle insertion during digital block
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Informed consent (according standard consent), age range: 16-50 years old, fingers trauma which need medical procedures or extra assessment under local anesthesia.
Exclusion criteria: Pregnant women, history of reaction to the local anesthetic agents, history of sensitivity to cold, unable to make communication, phobia, opium using during 6 hours before admission, emergent situations, unstable medically patients.
Age
From 16 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Type of randomization: Block Randomize
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Central building of Tehran University of Medical Science, Ghods Ave, Keshavarz Blvd, Tehran
City
Tehran
Postal code
1419732171
Approval date
2016-02-16, 1394/11/27
Ethics committee reference number
IR.TUMS.REC.1394.1986
Health conditions studied
1
Description of health condition studied
Finger trauma
ICD-10 code
M65, M66,
ICD-10 code description
Disorders of synovium and tendon, Other soft tissue disorders
Primary outcomes
1
Description
Pain due to needle stick of digital block
Timepoint
On admission, after using ice, time of skin needling, during injection.
Method of measurement
NRS Questionnaire
Secondary outcomes
1
Description
Patient satisfaction
Timepoint
At the end of procedure
Method of measurement
Questionnare
Intervention groups
1
Description
Case group: There are 50 patients in this group. Injured finger is covered by ice for 6 minutes before needling. Afterwards, finger is anesthetized by 3 milliliters lidocaine.
Category
Treatment - Other
2
Description
Control group: There are 50 patients in this group. Finger is anesthetized by using Lidocaine, with no ice application.