Comparison of hemodynamic index and duration of effect of two drugs, bupivacaine and ropevacaine during spinal and epidural analgesia in orthopedic lower extremity surgery and umbilical cord surgery (T8 level)
Comparison of hemodynamic index and duration of effect of two drugs, bupivacaine and ropevacaine during spinal and epidural analgesia in orthopedic surgery of the lower extremity and umbilicus (T8 level)
Design
Controlled clinical trial, randomized, double-blind, on 80 patients, randomized based on random function
Settings and conduct
Imam Reza Hospital in Birjand - 1398
Participants/Inclusion and exclusion criteria
Entry requirements:
Patients referred to Imam Reza Hospital who underwent lower limb orthopedics and umbilical cord surgery without underlying disease, using a tourniquet, without bleeding and operation time less than 1 hour and 45 minutes
Exit conditions:
People with any underlying disease, people who have a ban on spinal anesthesia (such as coagulation disorders, infection at the site of anesthesia, hypovolemia and unwillingness to anesthetize
Intervention groups
The first group (30 people) will receive 20 ml of rupivacaine
the second group (30 people) will receive 20 ml of bupivacaine.
Main outcome variables
Systolic pressure
Diastolic pressure
heart beat
Create sensory blocks
Length of effect of two drugs
side effects
Intensity of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210218050400N1
Registration date:2021-03-04, 1399/12/14
Registration timing:prospective
Last update:2021-03-04, 1399/12/14
Update count:0
Registration date
2021-03-04, 1399/12/14
Registrant information
Name
habibe momeni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3290 4004
Email address
habibe.momeni@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of hemodynamic index and duration of effect of two drugs, bupivacaine and ropevacaine during spinal and epidural analgesia in orthopedic lower extremity surgery and umbilical cord surgery (T8 level)
Public title
Comparison of hemodynamic index and duration of effect of two drugs, bupivacaine and ropevacaine during spinal and epidural analgesia in orthopedic lower extremity surgery and umbilical cord surgery (T8 level)
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Patients referred to Imam Reza Hospital who underwent lower limb orthopedics and umbilical cord surgery without underlying disease,
using a tourniquet
without bleeding and operation time less than 1 hour and 45 minutes
Exclusion criteria:
People with any underlying disease, people who have a ban on spinal anesthesia (such as coagulation disorders, infection at the site of anesthesia
and unwillingness to anesthetize
hypovolemia
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method will be simple random so that 60 cards with two different colors, each color will represent a group, will be placed in a box. After entering the operating room, the patient will first check the entry criteria and if Being the entry criterion, a card will be pulled out of the box and will be placed in the desired group (B or A) according to the color of the card.
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
Vice Chancellor for Research, Birjand University of Medical Sciences
Street address
Ghafari
City
Birjand
Province
South Khorasan
Postal code
9771648719
Approval date
2021-02-15, 1399/11/27
Ethics committee reference number
IR.BUMS.REC.1399.510
Health conditions studied
1
Description of health condition studied
Spinal T8 level
ICD-10 code
-
ICD-10 code description
2
Description of health condition studied
T8 level analgesic epidural
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
blood pressure
Timepoint
Every 5 minutes to 30 minutes after injection and then every 15 minutes until the end of the operation.
Method of measurement
Blood pressure monitor
2
Description
Blood oxygen level
Timepoint
Every 5 minutes to 30 minutes after injection and then every 15 minutes until the end of the operation
Method of measurement
Pulse oximetry
3
Description
Duration of anesthesia
Timepoint
Every 5 minutes to 30 minutes after injection and then every 15 minutes until the end of the operation
Method of measurement
Based on sensory level
4
Description
Intensity of sensory block
Timepoint
Every 5 minutes to 30 minutes after injection and then every 15 minutes until the end of the operation
Method of measurement
Based on sensory level
5
Description
The effectiveness of drugs
Timepoint
Intervals of 5 minutes for the first 30 minutes after injection
Method of measurement
Using 100 mm analog pain scores (VAPS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: 30 people in intervention group 1 will be injected 20 ml of rupivacaine into the epidural space once before the operation using a 3 cm multifunctional epidural catheter.
Category
Treatment - Drugs
2
Description
Intervention group 2: 30 people in intervention group 2 will be injected with 20 cm 20 ml bupivacaine into the epidural space once before the operation using a multifunctional epidural catheter.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital in Birjand
Full name of responsible person
Atiye Validad
Street address
Ghafari. Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
9771648719
Phone
+98 56 3290 4004
Email
Pooh199069@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Toba Kazemi
Street address
Ghafari, Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
9771648719
Phone
+98 56 3238 1200
Email
drtooba.kazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Atiye Validad
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ghafari
City
Birjand
Province
South Khorasan
Postal code
9771648719
Phone
+98 915 164 0940
Email
Pooh199069@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Atiye Validad
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ghafari
City
Birjand
Province
South Khorasan
Postal code
9771648719
Phone
+98 915 164 0940
Email
Pooh199069@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Atiye Validad
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ghafari
City
Birjand
Province
South Khorasan
Postal code
9771648719
Phone
+98 915 164 0940
Email
pooh199069@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
After submitting the proposal and collecting data and analyzing the results, the final report will be registered and the results will be published as an article.
When the data will become available and for how long
-
To whom data/document is available
General and field specialists
Under which criteria data/document could be used
After the publication of the article
From where data/document is obtainable
Corresponding
What processes are involved for a request to access data/document
Submit proposal, collect data, submit final report and publish article