1. Home
  2. Approved trials
  3. » فارسی

Comparative evaluation of lidocaine 0.5% and lidocaine 0.25% with pethidine for intravenous regional anesthesia in upper limb soft tissue surgery

Protocol summary

Study aim
Comparative evaluation of lidocaine 0.5% and lidocaine 0.25% with pethidine for intravenous regional anesthesia in upper limb soft tissue surgery
Design
The present clinical trial had a control group, with parallel groups, one-way blind, randomized, phase 2-3 on 50 patients. Sealedenveloped.com was used for randomization.
Settings and conduct
A person who is unaware of the type of study group is taking medication. In both study groups, single syringes with the same medicinal volume of 40 cc and the same color will be used. Profile of patients classified separately by the only person who has no involvement in the procedure information, not just the Physicians is uncertain. Patients in the first intervention group will receive 3 mg / kg lidocaine 2% in 40 cc syringe for biers block. Patients in the second intervention group will receive combination of 1.5 mg / kg lidocaine 2% and 1.5 mg / kg pethidine for biers block in 40 cc syringe.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: 18 to 60 years old, Patients Candidate for Upper Limb Surgery ASA One and Two. Exclusion Criteria:Heart disease ,High blood pressure and low blood pressure ,Bradycardia, Hyperthyroidism ,Cardiac block, Adrenoceptor agonist and antagonist , Peripheral neuropathy ,Pregnancy , Addiction , Allergy to the drugs used in the study, Coagulation Disorders ,Topical infections ,Patient refusal, Problems and deformities of musculoskeletal of the upper limb.
Intervention groups
Patients in the first intervention group will receive 3 mg / kg lidocaine 2% in 40 cc syringe for biers block. Patients in the second intervention group will receive combination of 1.5 mg / kg lidocaine 2% and 1.5 mg / kg pethidine for biers block in 40 cc syringe.
Main outcome variables
Evaluation of the blocks of sensory nerves within the four main branches of the hand nerve, Evaluation of motor nerve block .

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141009019470N115
Registration date: 2021-04-13, 1400/01/24
Registration timing: prospective

Last update: 2021-04-13, 1400/01/24
Update count: 0
Registration date
2021-04-13, 1400/01/24
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-19, 1400/01/30
Expected recruitment end date
2021-06-03, 1400/03/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of lidocaine 0.5% and lidocaine 0.25% with pethidine for intravenous regional anesthesia in upper limb soft tissue surgery
Public title
Comparative evaluation of lidocaine 0.5% and lidocaine 0.25% with pethidine for intravenous regional anesthesia in upper limb soft tissue surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
18 to 60 years old, Patients Candidate for Upper Limb Surgery ASA One and Two
Exclusion criteria:
Heart disease High blood pressure and low blood pressure Bradycardia Hyperthyroidism Cardiac block Using Adrenoceptor agonist and antagonist Peripheral neuropathy Pregnancy Addiction Allergy to the drugs used in the study Coagulation Disorders Topical infections Patient refusal Problems and deformities of musculoskeletal of the upper limb
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
All patients were randomly divided into two groups: A and B. Patients were randomly divided into two groups using Randomization.org site and Random permutations method.
Blinding (investigator's opinion)
Double blinded
Blinding description
A person who is unaware of the type of study group is taking medication. In both study groups, single syringes with the same medicinal volume of 40 cc and the same color will be used. Profile of patients classified separately by the only person who has no involvement in the procedure information, not just the Physicians is uncertain.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2020-01-21, 1398/11/01
Ethics committee reference number
IR.SUMS.MED.REC.1398.574

Health conditions studied

1

Description of health condition studied
upper limb surgeries
ICD-10 code
T79.A12D
ICD-10 code description
Traumatic compartment syndrome of left upper extremity, subsequent encounter

Primary outcomes

1

Description
Evaluation of the blocks of sensory nerves within the four main branches of the hand nerve.
Timepoint
Every 30 seconds
Method of measurement
Pin prick Test

2

Description
Evaluation of motor nerve block
Timepoint
Every 30 seconds
Method of measurement
Assessment of flexion and extension ability of wrists and fingers

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:Patients in the first intervention group will receive 3 mg / kg lidocaine 2% in 40 cc syringe for biers block.
Category
Prevention

2

Description
Intervention group: Patients in the second intervention group will receive combination of 1.5 mg / kg lidocaine 2% and 1.5 mg / kg pethidine for biers block in 40 cc syringe.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Chamran Hospital
Full name of responsible person
Heidar Safari
Street address
Chamran Hospital, Chamran Boulevard
City
Shiraz
Province
Fars
Postal code
7194815644
Phone
+98 71 3624 0101
Email
chamhosp@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemi
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
sacrc@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Heidar Safari
Position
Anesthesiology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
heidarsafari2031365@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Afshin Amini
Position
Anesthesiologist
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
aamini@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
BS in anesthesia/English Consultant
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
5th floor, Mohammad Rasoul Allah Research Tower, Khalili Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
masihifarzaneh@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Its against our policies.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...