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Trial registered on ANZCTR
Registration number
ACTRN12624001251516
Ethics application status
Approved
Date submitted
2/09/2024
Date registered
14/10/2024
Date last updated
19/10/2024
Date data sharing statement initially provided
14/10/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Comparison of the analgesic effectiveness of fascia iliaca compartment block combined with or without obturator block on position pain during spinal anesthesia.
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Scientific title
Comparison of the analgesic effectiveness of fascia iliaca compartment block combined with or without obturator block on position pain during spinal anesthesia in patients undergoing hip fracture surgery in patients aged 55 and over
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Secondary ID [1]
312829
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hip fracture
334938
0
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Condition category
Condition code
Anaesthesiology
331477
331477
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0
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Pain management
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Intervention/exposure
Study type
Observational
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Patient registry
True
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Target follow-up duration
2
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Target follow-up type
Hours
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Description of intervention(s) / exposure
Participants in this trial will be adults who have suffered a hip fracture and will undergo orthopedic surgery under spinal anesthesia(SA). Positioning for SA is a painful procedure. Usually, it is done after regional anesthesia.
Fascia iliaca compartment block(FICB) recommended to provide analgesia for this patient group. Obturator nerve block(ONB) can be added seperately to increase the effectivenes.
In our instutution, these patients recieve FICB with or without ONB based on anesthesia provider preferences regardless of study participation.
We will collect patients preoperative and intraoperative data. After data collection is completed, the patients will be divided in two group, Arm 1 and Arm 2 for statistical analysis.. This division will be performed based on the regional anesthesia technique used for position pain. In Arm 1, there will be patients who underwent FICB. In Arm 2 there will be patients who underwent FICB with ONB.
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Intervention code [1]
329404
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Not applicable
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Comparator / control treatment
As local instutional policy, any regional anesthesia technic will be applied to the patients 30 mins before spinal anesthesia. If there are no contraindication, SA is performed in sitting position.
FICB with or without ONB performed with real time ultrasound imaging,
For FIKB, suprainguinal region is preferred approach. 40ml 0,25%concentration of bupivacain will be injected with specified block needle by anesthesiologist
For ONB, 10 ml 0,25%concentration of bupivacain will be injected with specified block needle by anesthesiologist
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Control group
Active
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Outcomes
Primary outcome [1]
339259
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Pain
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Assessment method [1]
339259
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Visual Analog Scale(1 to 10)
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Timepoint [1]
339259
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immediately before application of any regional anesthesia and 30 minutes after application of regional anesthesia, at the time of spinal anesthesia application
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Secondary outcome [1]
439291
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Quality of Position
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Assessment method [1]
439291
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Likert Scale( 1 to 5)
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Timepoint [1]
439291
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30 minutes after application of regional anesthesia, at the time of spinal anesthesia application
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Eligibility
Key inclusion criteria
Patients aged 55 and over who are planned to undergo surgery under spinal anesthesia due to hip fracture
Patients who have planned FIKB or FIKB and ONB for analgesia during positioning
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Minimum age
55
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Any contraindications to the application of regional anesthesia techniques.
Presence of infection in the application area of any regional anesthesia techniques
History of previous operations that may result in changes in the fascial plan anatomy in the relevant application area
Patients who are planned to operate under general anesthesia and have planned FIKB and ONB or FIKB alone for preoperative and postoperative analgesia.
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Study design
Purpose
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/11/2024
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Actual
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Date of last participant enrolment
Anticipated
1/05/2025
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Actual
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Date of last data collection
Anticipated
1/05/2025
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Actual
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Sample size
Target
52
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
26533
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Turkey
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State/province [1]
26533
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Istanbul
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Funding & Sponsors
Funding source category [1]
317269
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Self funded/Unfunded
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Name [1]
317269
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Temel Guner
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Address [1]
317269
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Country [1]
317269
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Turkey
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Primary sponsor type
Individual
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Name
Temel Guner, Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital
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Address
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Country
Turkey
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Secondary sponsor category [1]
319588
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None
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Name [1]
319588
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Address [1]
319588
0
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Country [1]
319588
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316039
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Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital Non-Interventional Research Ethics Committee
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Ethics committee address [1]
316039
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Emek Mahallesi, Namik Kemal Cad. No:54, 34785 Sancaktepe / Istanbul
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Ethics committee country [1]
316039
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Turkey
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Date submitted for ethics approval [1]
316039
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05/09/2024
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Approval date [1]
316039
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18/09/2024
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Ethics approval number [1]
316039
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2024/287
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Summary
Brief summary
Osteoporosis is a major public health problem, especially seen frequently in the elderly population, and is associated with hip fractures. Spinal and general anesthesia can be preferred in the anesthetic management of surgical treatment of hip fractures. Fascia iliaca compartment block (FICB) is recommended as part of multimodal analgesia. During FICB, the obturator nerve, femoral nerve and lateral femoral cutaneous nerve are targeted. Since local anesthetic spread does not always ensure blockade of obturator nerve, Routine obturator nerve block application in combination of FICB may be preferred by the anesthesiologist. This study aimed to investigate the effectiveness of the routine use of ONB and FICB combination on pain during positioning compared to the use of FICB alone.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Temel Güner
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Address
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Prof. Dr. Ilhan Varank Training and Research Hospital, Emek, Namik Kemal St.. No:54, 34785 Sancaktepe/Istanbul
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Country
136482
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Turkey
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Phone
136482
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+90 531 9241992
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Fax
136482
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Email
136482
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[email protected]
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Contact person for public queries
Name
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Temel Güner
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Address
136483
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Prof. Dr. Ilhan Varank Training and Research Hospital, Emek, Namik Kemal St.. No:54, 34785 Sancaktepe/Istanbul
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Country
136483
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Turkey
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Phone
136483
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+90 531 9241992
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Fax
136483
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Email
136483
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[email protected]
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Contact person for scientific queries
Name
136484
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Temel Güner
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Address
136484
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Prof. Dr. Ilhan Varank Training and Research Hospital, Emek, Namik Kemal St.. No:54, 34785 Sancaktepe/Istanbul
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Country
136484
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Turkey
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Phone
136484
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+90 531 9241992
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Fax
136484
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Email
136484
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Patient information will be made anonymous and all data will be shared.
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When will data be available (start and end dates)?
Immediately following publication
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Available to whom?
only researchers who provide a methodologically sound proposal
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Available for what types of analyses?
Anonymous data will be available only for meta-analyses
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How or where can data be obtained?
Anonymous data will be shared by the principal investigator upon request via e-mail(
[email protected]
)
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
24280
Ethical approval
388356-(Uploaded-14-10-2024-16-21-07)-84fd9809a0ed4bbbb04d8d6a9d760b7e_UZM._DR._TEMEL_GUNER_BILIMSEL_ARASTIRMALAR_ETIK_KURUL__KARAR_FO.pdf
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.
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