The effect of hyperbaric bupivacaine dose on the incidence and severity of early complications after spinal anesthesia for orthopedic surgeries
Design
Clinical trial has three intervention groups, with parallel groups, double-blind, randomized, phase 2-3 on 60 patients. The Rand function of the Excel software was used for randomization.
Settings and conduct
60 adults aged 18 to 60 years old candidates for lower limb orthopedic surgeries in Shohada hospital based on inclusion criteria, will be randomly divided into three distinct groups A, B, and C, defined on the basis of hyperbaric bupivacaine 0.5% injection dosage into the intrathecal space [C: 20mg, B: 15mg, A: 12.5mg] and sampling will be double-blind. Patients and the person injecting the drug and filling out the questionnaires are unaware of the dose of the injected drug. Spinal anesthesia will be performed with a 23G Quincke Spinal needle in a sitting position from the L4-L5 space. Immediately after the injection, patients will be in the supine position, and vital signs and incidence of nausea and vomiting will be recorded at regular intervals.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18 to 60 years; Orthopedic lower limb surgeries; Having an indication for spinal anesthesia; Patients with ASA class I and II
Exclusion criteria: Patient discontent with spinal anesthesia; Uncontrolled blood pressure; Uncontrolled diabetes; History of previous neurological problems; Presence of coagulation problems; Hypersensitivity to anesthetics; Septicemia or local infection at the site of needle entry
Intervention groups
Three groups named A, B and C are defined based on the dose of bupivacaine 0.5% hyperbaric injection into the intrathecal space. 12.5 mg, 15 mg and 20 mg of bupivacaine will be injected intrathecally, respectively.
Main outcome variables
Heart rate; Blood pressure; Oxygen saturation; Nausea and vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160202026328N7
Registration date:2022-01-10, 1400/10/20
Registration timing:registered_while_recruiting
Last update:2022-01-10, 1400/10/20
Update count:0
Registration date
2022-01-10, 1400/10/20
Registrant information
Name
Masoud Parish
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3385 5842
Email address
parishm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-04-21, 1401/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of hyperbaric bupivacaine dosage on the incidence and severity of early complications after spinal anesthesia for orthopedic surgeries
Public title
The effect of hyperbaric bupivacaine dosage on the incidence and severity of early complications after spinal anesthesia for orthopedic surgeries
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 60 years
Orthopedic lower limb surgeries
Having an indication for spinal anesthesia
Patients with ASA class I and II
Exclusion criteria:
Patient discontent with spinal anesthesia
Uncontrolled blood pressure in the patient
Uncontrolled diabetes in the patient
History of previous neurological problems in the patient
Presence of coagulation problems in the patient
Hypersensitivity to anesthetics
Septicemia or local infection at the site of needle entry
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be selected based on inclusion and exclusion criteria and will be randomly assigned to treatment groups using permuted blocks. For randomization, the Rand function of Excel software is used, in which the randomization unit is individuals. Sampling will be double-blind and all the desired variables will be recorded based on a pre-prepared questionnaire.
Blinding (investigator's opinion)
Double blinded
Blinding description
The anesthesiologist, who is in charge of the patient's anesthesia management, injects the drug through coded syringes that have already been prepared by the thesis owner. So that anesthesiologist is unaware of the injected drug to patient during injection. The anesthesia nurse, who is responsible for collecting information and variables from the patient and is unaware of the type of prescribed drug, fills the checklist during surgery and recovery. The patient is also unaware of the type of Injecting drug.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Faculity of Medicine, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2021-11-29, 1400/09/08
Ethics committee reference number
IR.TBZMED.REC.1400.820
Health conditions studied
1
Description of health condition studied
Complications of spinal anesthesia
ICD-10 code
T88.59
ICD-10 code description
Other complications of anesthesia
Primary outcomes
1
Description
Blood pressure
Timepoint
Immediately after becoming supine and then at intervals of 5 minutes to half an hour and then every 15 minutes to an hour.
Method of measurement
In millimeters of mercury using a non-invasive method of measuring blood pressure by the device.
2
Description
Heart rate
Timepoint
Immediately after becoming supine and then at intervals of 5 minutes to half an hour and then every 15 minutes to an hour.
Method of measurement
Beat Per minute using a non-invasive heart rate monitor
3
Description
Hypoventilation and hypoxia
Timepoint
Immediately after becoming supine and then at intervals of 5 minutes to half an hour and then every 15 minutes to an hour
Method of measurement
Monitoring the respiratory rate per minute and measuring oxygen saturation by pulse oximetry
4
Description
Nausea and vomiting
Timepoint
Immediately after becoming supine and then at intervals of 5 minutes to half an hour and then every 15 minutes to an hour.
Method of measurement
Asking the patient
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group A: Three groups named A, B and C, which are defined based on the dose of hyperbaric bupivacaine 0.5% injection into the intrathecal space. In all three groups, in order to homogenize the interventions, the temperature of the solutions is the same and spinal anesthesia will be performed in sitting position and in sterile condition with a 23G Quincke spinal needle from the L4-L5 space. The surgeries will be the same and with a fixed duration. Immediately after the injection, patients will be in the supine position, and vital signs and incidence of nausea and vomiting will be recorded at regular intervals. For intervention group A, 12.5 mg of bupivacaine will be injected to intrathecal space.
Category
Treatment - Drugs
2
Description
Intervention group B: 15 mg of hyperbaric bupivacaine 0.5% will be injected to intrathecal space.
Category
Treatment - Drugs
3
Description
Intervention group C: 20 mg of hyperbaric bupivacaine 0.5% will be injected to intrathecal space.
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All potential data can be shared after making peoples unrecognizable.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
The data will be available to researchers working in academia and people in industry.
Under which criteria data/document could be used
There are no specific restrictions on the use of data or documentation.
From where data/document is obtainable
Dr .Masoud Parish
Department of Anesthesiology, Faculty of Medicine, Golgasht Street, Tabriz East Azarbaijan Islamic Republic of Iran
Phone: +98 413 3341994,
masoudparish@yahoo.com
What processes are involved for a request to access data/document
Applicants will have access to the data from the present study by sending an email to the responsible author for a maximum of one week.