Objective: to compare the effectiveness of ultrasound guidance in local analgesic block of the posterior tibial nerve.
Design: a block-randomized, not blinded clinical trial.
Study population: patients requiring posterior tibial nerve blocks.
Inclusion criteria: age over 18 years, isolated trauma in posterior tibial nerve, and lack of previous ankle deformity.
Exclusion criteria: multiple trauma, ankle injury, and previous history of consumption of analgesics. Sample size: 80 cases.
Study intervention: the control group received the common methods (i.e., anatomical landmarks) for posterior tibial nerve block. On the other hand, the intervention group was administered posterior tibial nerve blocks using ultrasound guidance. In this method, the anesthetic drug was injected near the nerve causing pain.
Study outcome: evaluation and comparison of anesthesia level and duration based on Visual Analogue Scale and Quality Block (i.e., sensory and motor block), based on cold and pinprink, 15 and 30 minutes after the intervention in both the intervention and control groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041733477N1
Registration date:2017-06-01, 1396/03/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-01, 1396/03/11
Registrant information
Name
Reza Ahmadi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 3007
Email address
ebrahimimn@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial on the effect of ultrasound guidance on local analgesic block of the posterior tibial nerve
Public title
The effect of ultrasound guidance on local analgesic block
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age over 18 years, isolated trauma in posterior tibial nerve, and lack of previous ankle deformity.
Exclusion criteria: multiple trauma, ankle injury, and previous history of consumption of analgesics.
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
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 Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Postal code
Approval date
2016-03-27, 1395/01/08
Ethics committee reference number
IR.MUMS.fm.REC.1395.234
Health conditions studied
1
Description of health condition studied
Injury of nerves at ankle
ICD-10 code
S94
ICD-10 code description
Injury of nerves at ankle and foot level
Primary outcomes
1
Description
Pain
Timepoint
15 and 30 minutes after intervention
Method of measurement
Based on Visual Analogue Scale (VAS)
2
Description
Analgesic duration
Timepoint
After intervention
Method of measurement
Minutes
Secondary outcomes
1
Description
Quality of nerve blocks (i.e., sensory and motor block)
Timepoint
15 and 30 minutes after intervention
Method of measurement
Physical examination
Intervention groups
1
Description
The intervention group: Who was administered posterior tibial nerve blocks using ultrasound guidance. In this method, the anesthetic drug is injected near the nerve, causing pain.
Category
Treatment - Other
2
Description
The control group: Who received the common methods (i.e., anatomical landmarks) for posterior tibial nerve block.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Reza Ahmadi
Street address
Imam Reza Hospital, Imam Reza Square, Ibn Sina Street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Ebrahimi
Position
Emergency Medicine
Other areas of specialty/work
Street address
Ghoreyshi Building, Daneshgah street
City
Mashhad
Postal code
Phone
+98 51 3854 3031
Fax
Email
EbrahimiMN@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Ebrahimi
Position
Emergency Medicine
Other areas of specialty/work
Street address
Ghoreyshi Building, Daneshgah street
City
Mashhad
Postal code
Phone
+98 51 3854 3031
Fax
Email
EbrahimiMN@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reza Ahmadi
Position
Emergency Medicine
Other areas of specialty/work
Street address
Ghoreyshi Building, Daneshgah street
City
Mashhad
Postal code
Phone
+98 51 3854 3031
Fax
Email
ahmadi_ums@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)