Determining the appropriate dose of Ropivacaine in umbilical cord surgery, reducing the failure rate and minimizing the side effects of spinal block
Design
Clinical trial with 4 intervention groups, double-blind, randomized, phase 2 on 140 patients. Random block allocation with 8 blocks is used for randomization.
Settings and conduct
The study site was located in Shahid Beheshti Hospital located in Qom. As a random selection of patients in need of umbilical cord surgery, the 8-block method is used for placement in intervention groups. Two-way blinding including data recorder and data analyzer .
Participants/Inclusion and exclusion criteria
Inclusion criteria: The patient is over 18 years old, has a broken arm and needs surgery, and has American Stroke Association level 1 or 2. Exclusion criteria: The patient is addicted to drugs, is pregnant, non-Iranian race, is not satisfied to enter this study.
Intervention groups
Intervention group 1: Patients for spinal anesthesia receive 4 ml of Ropivacaine 0.5% equivalent to 20 mg.
Intervention group 2: Patients for spinal anesthesia receive 4.5 ml of 0.5% Ropivacaine equivalent to 22.5 mg.
Intervention group 3: Patients for spinal anesthesia receive 5 ml of Ropivacaine 0.5% equivalent to 25 mg.
Intervention group 4: Patients receive 5.5 ml of Ropivacaine equal to 27.5 mg for spinal anesthesia.
Main outcome variables
The quality of anesthesia for the patient in terms of comfort during the operation and the need for painkillers after surgery; The length of stay of patients in the recovery department after surgery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211017052786N4
Registration date:2022-07-11, 1401/04/20
Registration timing:registered_while_recruiting
Last update:2022-07-11, 1401/04/20
Update count:0
Registration date
2022-07-11, 1401/04/20
Registrant information
Name
Amir Hossein Moradi Rafigh
Name of organization / entity
Qom university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 25 3885 6440
Email address
amirmmr287@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2022-07-22, 1401/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effect of Four Different Doses of Intrathecal Isobaric Ropivacaine on Patients Undergoing Elective Infra-umbilical Surgeries
Public title
Comparison of the effect of different doses of intrathecal Ropivacaine in surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian race
Patients with American Stroke Association (ASA) grade 1, 2
Umbilical cord surgeries
Age over 18 and under 65 years
Exclusion criteria:
Allergy to amide drugs
Pregnancy
History of substance abuse
Heart rate less than 60 beats per minute at rest
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 140 patients undergoing umbilical cord surgery will be randomly divided into four groups of 35 patients. Random assignment of patients to four groups is based on block method. Each block will be selected at random. Block Randomization is done using dice. Throwing the dice will be done enough to complete the assignment of patients to treatment groups. The size of the block is 8 and we will have different and random combinations of AABBCCDD. The selection of each block will be random to complete the allocation of patients to treatment groups with four different doses. Assignment of treatment to groups A, B, C and D will also be based on accident.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind randomized clinical trial (RCT) in which the participating patients, specialist assistant and surgeon do not know the type of dose assignment to the group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of QOM University of Medical Sciences
Street address
No.10, 13th Ave., Emam Street.
City
Qom
Province
Ghoum
Postal code
3718913997
Approval date
2022-06-19, 1401/03/29
Ethics committee reference number
IR.MUQ.REC.1401.064
Health conditions studied
1
Description of health condition studied
Spinal anesthesia using ropivacaine
ICD-10 code
T88.5
ICD-10 code description
Other complications of anesthesia
Primary outcomes
1
Description
Levels of sensory and motor block
Timepoint
In minutes 15,10,8,8,6,4,2
Method of measurement
Motor nerves using voice commands for the patient and Pinprick of skin to observe the sensory nerve response
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Candidate patients for below-umbilical surgery for spinal anesthesia receive 4 ml of 0.5% Ropivacaine with chemical formula (C17H26N2O) equivalent to 20 mg intra-cerebrospinal fluid (CSF).
Category
Treatment - Other
2
Description
Intervention group 2: Candidate patients for below-umbilical surgery for spinal anesthesia receive 4.5 ml of Ropivacaine 0.5% with chemical formula (C17H26N2O) equivalent to 22.5 mg intra-cerebrospinal fluid (CSF).
Category
Treatment - Other
3
Description
Intervention group 3: Candidate patients for below-umbilical surgery for spinal anesthesia receive 5 ml of 0.5% Ropivacaine with chemical formula (C17H26N2O) equivalent to 25 mg intra-cerebrospinal fluid (CSF).
Category
Treatment - Other
4
Description
Intervention group 4: Candidate patients for below-umbilical surgery for spinal anesthesia receive 5.5 ml of Ropivacaine 0.5% with chemical formula (C17H26N2O) equivalent to 27.5 mg intra-cerebrospinal fluid (CSF)..
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Hamed Shafiee
Street address
Shahid Beheshti Blvd
City
Qom
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2000
Email
Bmc@muq.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Vahid Damanpak
Street address
No. 83, Forth Ave., Safa Shahr Street
City
Qom
Province
Ghoum
Postal code
3716987366
Phone
+98 25 3285 2720
Email
Amirmmr287@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum 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
Ghoum University of Medical Sciences
Full name of responsible person
Amir Hossein Moradi Rafigh
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
No. 46, 32th Ave., Keshavarz Shomali Blvd.
City
Qom
Province
Ghoum
Postal code
3715178817
Phone
+98 25 3885 6440
Email
Amirmmr287@gamil.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Fatemeh Gghannadi
Position
Residnet
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 46, 32th Ave., Keshavarz Shomali Blvd.
City
Qom
Province
Ghoum
Postal code
3715178817
Phone
+98 25 3885 6440
Email
Amirmmr287@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Amir Hossein Moradi Rafigh
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
No. 46, 32th Ave., Keshavarz Shomali Blvd.
City
Qom
Province
Ghoum
Postal code
3715178817
Phone
+98 25 3885 6440
Email
Amirmmr287@gmail.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