To investigate the results of single-injection nerve block for digital anesthesia
Design
Randomized controlled clinical trial
Settings and conduct
The study will be conducted in Shohada-ye Ashayer Teaching Hospital, in Khorramabd, Iran. Participants will be recruited from those who require hand surgery in the center and meet the inclusion criteria.
As the surgeon and the patients will notice the difference between traditional injection and single injection technique, blinding is not possible.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients requiring hand surgery at Shohada-ye Ashayer Teaching Hospital in Khorramabad, age 18 years and older
Exclusion criteria: Subjects with a history of previous surgery on the ipsilateral hand, subjects who discontinue their cooperation with the research team
Intervention groups
Intervention group: The single injection method will be performed by injecting 3 ml of 1% lidocaine at the base of the finger in the proximal volar metacarpophalangeal region.
Control group: The traditional technique will be performed by injecting 1.5 ml of 1% lidocaine without epinephrine in each lateral part of the base of the finger, just distal to the metacarpophalangeal joint, at the level of the web spaces. In all cases, a 27 G needle will be used.
Main outcome variables
Change in the pain reported by the patient (pain measured by the Visual Analogue Scale)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230410057871N1
Registration date:2023-07-09, 1402/04/18
Registration timing:prospective
Last update:2023-07-09, 1402/04/18
Update count:0
Registration date
2023-07-09, 1402/04/18
Registrant information
Name
Arian Karimi Rouzbahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3324 1229
Email address
arian.karimi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Results of Single-Injection Nerve Block with the Traditional Method in Patients Requiring Digital Anesthesia
Public title
Investigation of the Results of Single-injection Nerve Block
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients requiring hand surgery at Shohada-ye Ashayer Teaching Hospital in Khorramabad.
Age 18 years and older
Exclusion criteria:
Subjects with a history of previous surgery on the ipsilateral hand
Subjects who discontinue their cooperation with the research team
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed using the Balanced Block Randomization method and the participants will be divided into single-injection or control (traditional injection) groups.
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 Lorestan University of Medical Sciences
Street address
Lorestan University of Medical Sciences, opposite Kahrizak village, km 5 of Khorramabad Road - Boroujerd, Khorramabad, Lorestan, Iran
City
Khorramabad
Province
Lorestan
Postal code
6814993165
Approval date
2023-02-15, 1401/11/26
Ethics committee reference number
IR.LUMS.REC.1401.303
Health conditions studied
1
Description of health condition studied
Hand surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Change in the pain reported by the patient (pain measured by the Visual Analogue Scale)
Timepoint
The pain level will be recorded patient at 1, 3, 5, 15, and 20 minutes.
Method of measurement
The patient's pain after the injection is measured with a ruler that ranges from 0 to 10 cm so that 0 is the sign of no pain and 10 is the most severe pain ever experienced.
Secondary outcomes
1
Description
Analgesia onset time in patients in the two groups
Timepoint
Minutes 1, 3, 5, 15 and 20
Method of measurement
The level of pain will be recorded at 1, 3, 5, 15, and 20 minutes.
2
Description
The rate of complications caused by the treatment including arterial blood oxygen saturation below 90% for more than 60 seconds, change in pulse rate or blood pressure (increase or decrease), change in respiratory rate (increase or decrease), side effects (nausea and vomiting or loss of consciousness)
Timepoint
Minutes 1, 3, 5, 15 and 20
Method of measurement
Arterial blood oxygen saturation will be measured by a pulse oximeter from the first finger of the right or left hand. Any drop below 90% for more than 60 seconds will be considered positive. Its absolute amount will be recorded in the 5 defined times.
3
Description
Overall satisfaction of patients 60 minutes after the end of receiving the medication
Timepoint
Minutes 1, 3, 5, 15 and 20
Method of measurement
Overall satisfaction will be evaluated based on a 5-point scale (0=poor, 1=moderate, 2=good, 3=very good, 4=excellent) within 60 minutes after receiving the medication.
Intervention groups
1
Description
Intervention group: The single injection method will be performed by injecting 3 ml of 1% lidocaine at the base of the finger in the proximal volar metacarpophalangeal region. In all cases, a 27 G needle will be used.
Category
Treatment - Surgery
2
Description
Control group: The traditional technique will be performed by injecting 1.5 ml of 1% lidocaine without epinephrine in each lateral part of the base of the finger, just distal to the metacarpophalangeal joint, at the level of the web spaces.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada-ye Ashayer Teaching Hospital
Full name of responsible person
Mohammad Kazem Shahmoradi
Street address
Iran, Lorestan, Khorramabad, Enghelab St
City
Khorramabad
Province
Lorestan
Postal code
68169 33132
Phone
+98 66 3323 6401
Email
Shahmoradi.m@lums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Bahram Rasoulian
Street address
Lorestan University of Medical Sciences, opposite Kahrizak village, km 5 of Khorramabad Road - Boroujerd, Khorramabad, Lorestan, Iran
City
Khorramabad
Province
Lorestan
Postal code
6814993165
Phone
+98 66 3330 0661
Email
rasoulian@lums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Arian Karimi Rouzbahani
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Surgery
Street address
Lorestan University of Medical Sciences, opposite Kahrizak village, km 5 of Khorramabad Road - Boroujerd, Khorramabad, Lorestan, Iran
City
Khorramabad
Province
Lorestan
Postal code
6814993165
Phone
+98 930 675 7977
Email
arian.karimi@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Mohammad Kazem Shahmoradi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Iran, Lorestan, Khorramabad, Enghelab St
City
Khorramabad
Province
Lorestan
Postal code
68169 33132
Phone
+98 66 3323 6401
Email
Shahmoradi.m@lums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Arian Karimi Rouzbahani
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Surgery
Street address
Lorestan University of Medical Sciences, opposite Kahrizak village, km 5 of Khorramabad Road - Boroujerd, Khorramabad, Lorestan, Iran
City
Khorramabad
Province
Lorestan
Postal code
6814993165
Phone
+98 930 675 7977
Email
arian.karimi@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available