Protocol summary
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Study aim
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Comparison of the effects of general anesthesia and regional anesthesia in the clinical outcome of spinal surgery
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Design
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A randomized clinical trial with parallel group design on 100 patients.
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Settings and conduct
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Patients admitted to the neurosurgery ward of Imam Hossein Hospital in Tehran
admitted with a diagnosis of discopathy and no pedicle screw indication
Informed consent for both methods includes general anesthesia or regional anesthesia.
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Participants/Inclusion and exclusion criteria
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All patients with spinal discopathy who need surgery for the first time and have no history of hepatic, renal, and pulmonary failure, and the presence of any coagulopathy
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Intervention groups
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50% of patients take general anesthesia and 50% take regional anesthesia
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Main outcome variables
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Oswestry disability index; bleeding volume during and after surgery; surgery duration; anesthesia duration; acetaminophen dose usage
General information
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Reason for update
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To clarify to more extent, literary corrections were made.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210722051955N1
Registration date:
2021-08-07, 1400/05/16
Registration timing:
prospective
Last update:
2023-05-29, 1402/03/08
Update count:
1
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Registration date
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2021-08-07, 1400/05/16
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-08-23, 1400/06/01
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Expected recruitment end date
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2022-08-23, 1401/06/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of general anesthesia and regional anesthesia in clinical outcome of lumbar spine surgery
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Public title
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A comparative study of general anesthesia vs regional anesthesia in spinal surgery.
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with discopathy who need surgery
Signing a written consent to enter the study
Spinal surgery for the first time
Exclusion criteria:
Pedicle screw indication
Renal, hepatic or pulmonary failure
Coagolopathy
Contraindication for regional anesthesia
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Age
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No age limit
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
100
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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All patients who enrolled in the study will given a random number and through a randomized table will be divided into 2 groups.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-02-16, 1399/11/28
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Ethics committee reference number
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IR.SBMU.MSP.REC.1399.716
Health conditions studied
1
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Description of health condition studied
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Lumbar discopathy
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ICD-10 code
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M51.1
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ICD-10 code description
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Thoracic, thoracolumbar and lumbosacral intervertebral disc disorder with radiculopathy
Primary outcomes
1
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Description
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Operation duration
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Timepoint
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Start and end point of the surgery
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Method of measurement
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Time based on minutes
Secondary outcomes
1
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Description
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Blood loss
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Timepoint
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Before surgery and the point of discharge
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Method of measurement
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Hemoglobin and volume of drainage
2
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Description
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Pain
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Timepoint
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After surgery
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Method of measurement
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Used paracetamol in gram
3
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Description
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Vital signs
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Timepoint
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Before procedure, Prone position, Supine position
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Method of measurement
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Heart Rate , Blood Pressure
4
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Description
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Nausea/Vomiting
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Timepoint
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After surgery
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Method of measurement
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Used antiemetic and subjective patient complaint
Intervention groups
1
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Description
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Intervention group: Regional anesthesia with epidural injection of Pethidine 1mg/kg (Aburaihan co) and intravenous injection of Dexmedetomidine 0.2μg/kg (Exir co)
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Category
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Treatment - Surgery
2
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Description
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Control group: In General anesthesia group . Induction with Propofol 2mg/kg and Fentanyl 4mg/kg (Caspian co) and Maintenance with Isoflurane (Baxter co).
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Category
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Treatment - Surgery
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All information is publishable except names of patients.
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When the data will become available and for how long
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1 year after publish
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To whom data/document is available
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Everyone
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Under which criteria data/document could be used
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Unlimited
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From where data/document is obtainable
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Personal email
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What processes are involved for a request to access data/document
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1 week after email reception
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Comments
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