Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000740695
Ethics application status
Approved
Date submitted
30/05/2023
Date registered
10/07/2023
Date last updated
12/07/2023
Date data sharing statement initially provided
10/07/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
We aimed to investigate the effects of bilateral sphenopalatine ganglion blockade (SPGB) on postoperative early complications in septorhinoplasty operations.
Scientific title
Randomized Clinical Trial Doubled Blind Study of Bilateral Sphenopalatine ganglion Blockade in Septorhinoplasty Operations
Secondary ID [1] 309790 0
none
Universal Trial Number (UTN)
U1111-1292-3567
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
septum deviation 330199 0
sphenopalatine ganglion blockade 330200 0
Condition category
Condition code
Anaesthesiology 327071 327071 0 0
Pain management
Surgery 327261 327261 0 0
Other surgery
Respiratory 327262 327262 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sphenopalatine group (Group S, n=40). It was applied with infiltration anesthesia to both groups by the same otolaryngologist with the Sphenocath device(SphenoCath Applicator; Dolor Technologies, Scottsdale, Arizona). SPG blockade was performed by a otolaryngologist blinded to the drug used. Patients in group S were performed bilaterally with 2 mL of 0.025% adrenalin-free intranasal bupivacaine (Marcaine 0.5% vial, Astra-Zeneca, Germany) 15 minutes before the end of the operation. The results were evaluated by an anesthesiologist who was not involved in the study. In the recovery unit after the operation; The pain and analgesic needs of the patients at 0, 2, 6 and 24 hours were evaluated. The presence of laryngospasm and the frequency of nausea and vomiting in the first 24 hours were recorded during the recovery period.
Intervention code [1] 326221 0
Prevention
Comparator / control treatment
In the control group (Group C, n=40), 2 mL of 0.9% NaCl solution was applied into both SPG areas. It was applied with infiltration anesthesia to both groups by the same otolaryngologist with the Sphenocath device(SphenoCath Applicator; Dolor Technologies, Scottsdale, Arizona). SPG blockade was performed by a otolaryngologist blinded to the drug used. In the recovery unit after the operation; The pain and analgesic needs of the patients at 0, 2, 6 and 24 hours were evaluated. The presence of laryngospasm and the frequency of nausea and vomiting in the first 24 hours were recorded during the recovery period.
Control group
Active

Outcomes
Primary outcome [1] 334926 0
After septorhinoplasty operations; In the recovery unit, pain was evaluated by the anesthesiologist at 0 (t1), 2nd (t2), 6th (t3) and 24th (t4) hours using a visual analog scale [11] (0: no pain, 10: maximum)..
Timepoint [1] 334926 0
First 24 hours after sphenopalatine ganglion injection
Secondary outcome [1] 422474 0
After septorhinoplasty operations; In the recovery unit, Postoperative analgesic requirement was evaluated by the anesthesiologist( at 0-2 hours,2-24 hours ve total)..
Timepoint [1] 422474 0
First 24 hours after sphenopalatine ganglion injection
Secondary outcome [2] 423236 0
After septorhinoplasty operations; In the recovery unit, nausea-vomiting scale was evaluated by the anesthesiologist. .POBC (postoperative nausea and vomiting), Numeric Rank Score (NRS) for 24 hours following the end of the operation (0: No nausea, vomiting, 1: Nausea, no vomiting, 2: Vomiting once, 3: Two or more episodes of vomiting ) and three different periods (NRS1: 0–2 hours, NRS2: 2–6 hours, NRS3: 6–24 hours)
Timepoint [2] 423236 0
First 24 hours after sphenopalatine ganglion injection
Secondary outcome [3] 423237 0
After septorhinoplasty operations; In the recovery unit, presence of laryngospasm was evaluated by the anesthesiologist.
Timepoint [3] 423237 0
First hours after sphenopalatine ganglion injection

Eligibility
Key inclusion criteria
Patients aged 18-50 who will undergo elective septorhinoplasty operations.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant, known allergy to any of the study drugs, significant cardiac or renal pathology, regular sedative drug intake, atrioventricular block, myasthenia gravis, uncooperative (due to dementia, mental retardation, etc.) , drug or alcohol addiction, and patients who did not want to participate in the study were excluded.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/07/2023
Actual
3/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
15
Final
Recruitment outside Australia
Country [1] 25564 0
Turkey
State/province [1] 25564 0
DIYARBAKIR

Funding & Sponsors
Funding source category [1] 313972 0
Hospital
Name [1] 313972 0
Health Sciences University Diyarbakir Gazi Yasargil Research and Education Hospital, Diyarbakir, Turkey
Country [1] 313972 0
Turkey
Primary sponsor type
Individual
Name
ERHAN GÖKÇEK
Address
Talaytepe, Üçkuyular Mahallesi Elazig Yolu, Üzeri 10.Km, 21010 Kayapinar/Diyarbakir
Country
Turkey
Secondary sponsor category [1] 315845 0
None
Name [1] 315845 0
Address [1] 315845 0
Country [1] 315845 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313107 0
Health Sciences University Diyarbakir Gazi Yasargil Research and Education Hospital, Diyarbakir, Turkey
Ethics committee address [1] 313107 0
Ethics committee country [1] 313107 0
Turkey
Date submitted for ethics approval [1] 313107 0
23/03/2022
Approval date [1] 313107 0
21/04/2022
Ethics approval number [1] 313107 0
66

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127030 0
A/Prof Erhan Gökçek
Address 127030 0
Diyarbakir Gazi Yasargil Research and Education Hospital, Elazig Yolu 10. Km Üçkuyular Mevkii 21070 Kayapinar/Diyarbakir
Country 127030 0
Turkey
Phone 127030 0
+905074453164
Fax 127030 0
Email 127030 0
[email protected]
Contact person for public queries
Name 127031 0
Erhan Gökçek
Address 127031 0
Diyarbakir Gazi Yasargil Research and Education Hospital, Elazig Yolu 10. Km Üçkuyular Mevkii 21070 Kayapinar/Diyarbakir
Country 127031 0
Turkey
Phone 127031 0
+905074453164
Fax 127031 0
Email 127031 0
[email protected]
Contact person for scientific queries
Name 127032 0
Erhan Gökçek
Address 127032 0
Diyarbakir Gazi Yasargil Research and Education Hospital, Elazig Yolu 10. Km Üçkuyular Mevkii 21070 Kayapinar/Diyarbakir
Country 127032 0
Turkey
Phone 127032 0
+905074453164
Fax 127032 0
Email 127032 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
after de-identification; individual participant data underlying published results only
When will data be available (start and end dates)?
available for 5 years after publication
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
access subject to approvals by Principal Investigator ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.