Protocol summary
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Study aim
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The aim of this study is to investigate the amount of postoperative pain and analgesic drug consumption in patients with supraorbital and infraorbital nerve block (BSIB) by bupivacaine, after rhinoplasty surgery.
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Design
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A three-blind randomized clinical trial study with one control group and three intervention groups with parallel groups on 200 patients (each group 50 people). The random block method will be used for randomization.
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Settings and conduct
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Khalili Hospital and Bo Ali Sina Hospital affiliated to Shiraz University of Medical Sciences
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Participants/Inclusion and exclusion criteria
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Primary rhinoplasty will be performed in all patients with standard technique and oblique lateral-medial osteotomy. Patients whose physical condition was ASA I based on the American Anesthesiology classification (ASA) and between 17 and 50 years of age will be included in the study.
Exclusion criteria are: lack of consent to participate in the study, patients with cardiovascular problems, history of sensitivity to bupivacaine, receiving other anesthetics before and during surgery, and cognitive disorders and inability to communicate and express the level of pain.
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Intervention groups
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Patients who will undergo primary rhinoplasty.
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Main outcome variables
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The amount of nasal pain, the use of analgesics, the amount of nausea-vomiting and postoperative complications
General information
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Reason for update
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The actual recruitment start and end date were added.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20131020015083N5
Registration date:
2024-02-07, 1402/11/18
Registration timing:
prospective
Last update:
2025-04-24, 1404/02/04
Update count:
1
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Registration date
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2024-02-07, 1402/11/18
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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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2024-02-20, 1402/12/01
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Expected recruitment end date
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2024-07-22, 1403/05/01
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Actual recruitment start date
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2024-02-22, 1402/12/03
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Actual recruitment end date
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2024-07-15, 1403/04/25
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Trial completion date
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empty
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Scientific title
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Investigating the effect of injectable and topical Bupivacaine on post operative pain after rhinoplasty
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Public title
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Investigating the effect of Bupivacaine on post operative pain after rhinoplasty
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
ASA I physical status based on the American Classification of Anesthesiology (ASA)
Age between 17 and 50 years
Performing primary rhinoplasty with standard technique and oblique lateral-medial osteotomy
Exclusion criteria:
Not agreeing to participate in the study
Patients with cardiovascular disease
History of sensitivity to bupivacaine
Receiving other anesthetics before and during the operation
Cognitive disorders and the inability to communicate and express the level of pain
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Age
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From 17 years old to 50 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
50
Actual sample size reached:
55
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Participants were randomly assigned to injection (number 0 in select case) or topical (number 1 in select case), combined (number 2 in select case), and control (number 3 in select case) groups (1:1:1:1 ratio) using random numbers which were generated through computerized block randomization using SPSS software version 23. To reduce selection bias and confounding factors, randomization was performed by a single appointed researcher who did not participate in data collection.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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Participant, Care provider, Investigator, Outcome assessor, Data analyser, and Data and Safety Monitoring Board were unaware of the intervention and allocation of treatments until the statistical analysis was complete.
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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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2024-01-16, 1402/10/26
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Ethics committee reference number
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IR.SUMS.MED.REC.1402.477
Health conditions studied
1
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Description of health condition studied
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patients underwent rhinoplasty
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ICD-10 code
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Z42
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ICD-10 code description
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Encounter for plastic and reconstructive surgery following medical procedure or healed injury
Primary outcomes
1
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Description
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Degree of nasal pain
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Timepoint
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1 hour after the operation, 6 hours after the operation, 1 day after the operation, 2 days after the operation and 3 days after the operation
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Method of measurement
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Visual analog scale (VAS)
2
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Description
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analgesic consumption
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Timepoint
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1 hour after the operation, 6 hours after the operation, 1 day after the operation, 2 days after the operation and 3 days after the operation
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Method of measurement
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Asking the patient directly and recording analgesic consumption
Secondary outcomes
1
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Description
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Nausea-vomiting
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Timepoint
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1 hour after the operation, 6 hours after the operation, 1 day after the operation, 2 days after the operation and 3 days after the operation
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Method of measurement
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Visual analog scale
2
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Description
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Postoperative complications
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Timepoint
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up to 7 days
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Method of measurement
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direct physical examination
Intervention groups
1
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Description
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patients who at the end of the operation (before the patient regains consciousness) will be injected with bupivacaine (Marcaine® 0.5%: Aspen Japan; Tokyo, Japan) with a total volume of 4 ml as a local anesthetic.
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Category
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Prevention
2
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Description
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Intervention group:There are patients who will be administered local anesthetic bupivacaine (Marcaine® 0.5%: Aspen Japan; Tokyo, Japan) with a total volume of 4 ml at the beginning of the procedure.
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Category
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Prevention
3
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Description
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Intervention group: There are patients who receive local bupivacaine through the mesh (each mesh 1 cc, 2 cc in total) at the beginning of the procedure and bupivacaine injection (0.5 cc in each point, 2 cc in total) at the end of the procedure (a total of 4 cc of bupivacaine).
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Category
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Prevention
4
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Description
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Control group: No local anesthesia will be used
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Category
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Other
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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Shiraz 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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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be 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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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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all collected deidentified IPD
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When the data will become available and for how long
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sarting 6 months after publication
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To whom data/document is available
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only available for people working in academic institutions.
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Under which criteria data/document could be used
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there is no specified criteria
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From where data/document is obtainable
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corresponding author (09177395073, babaei@sums.ac.ir)
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What processes are involved for a request to access data/document
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the request should be sent by email (containing personal and professional information), describing their study protocol, after approving their identity and proposal, the data will be sent by email.
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Comments
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