Trial Review

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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.
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
Secondary ID [1] 312829 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip fracture 334938 0
Condition category
Condition code
Anaesthesiology 331477 331477 0 0
Pain management

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
2
Target follow-up type
Hours
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.
Intervention code [1] 329404 0
Not applicable
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
Control group
Active

Outcomes
Primary outcome [1] 339259 0
Pain
Timepoint [1] 339259 0
immediately before application of any regional anesthesia and 30 minutes after application of regional anesthesia, at the time of spinal anesthesia application
Secondary outcome [1] 439291 0
Quality of Position
Timepoint [1] 439291 0
30 minutes after application of regional anesthesia, at the time of spinal anesthesia application

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
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
1/05/2025
Actual
Date of last data collection
Anticipated
1/05/2025
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment outside Australia
Country [1] 26533 0
Turkey
State/province [1] 26533 0
Istanbul

Funding & Sponsors
Funding source category [1] 317269 0
Self funded/Unfunded
Name [1] 317269 0
Temel Guner
Country [1] 317269 0
Turkey
Primary sponsor type
Individual
Name
Temel Guner, Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital
Address
Country
Turkey
Secondary sponsor category [1] 319588 0
None
Name [1] 319588 0
Address [1] 319588 0
Country [1] 319588 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316039 0
Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital Non-Interventional Research Ethics Committee
Ethics committee address [1] 316039 0
Ethics committee country [1] 316039 0
Turkey
Date submitted for ethics approval [1] 316039 0
05/09/2024
Approval date [1] 316039 0
18/09/2024
Ethics approval number [1] 316039 0
2024/287

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

Contacts
Principal investigator
Name 136482 0
Dr Temel Güner
Address 136482 0
Prof. Dr. Ilhan Varank Training and Research Hospital, Emek, Namik Kemal St.. No:54, 34785 Sancaktepe/Istanbul
Country 136482 0
Turkey
Phone 136482 0
+90 531 9241992
Fax 136482 0
Email 136482 0
temelguner@hotmail.com.tr
Contact person for public queries
Name 136483 0
Temel Güner
Address 136483 0
Prof. Dr. Ilhan Varank Training and Research Hospital, Emek, Namik Kemal St.. No:54, 34785 Sancaktepe/Istanbul
Country 136483 0
Turkey
Phone 136483 0
+90 531 9241992
Fax 136483 0
Email 136483 0
temelguner@hotmail.com.tr
Contact person for scientific queries
Name 136484 0
Temel Güner
Address 136484 0
Prof. Dr. Ilhan Varank Training and Research Hospital, Emek, Namik Kemal St.. No:54, 34785 Sancaktepe/Istanbul
Country 136484 0
Turkey
Phone 136484 0
+90 531 9241992
Fax 136484 0
Email 136484 0
temelguner@hotmail.com.tr

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Patient information will be made anonymous and all data will be shared.
When will data be available (start and end dates)?
Immediately following publication
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
Anonymous data will be available only for meta-analyses
How or where can data be obtained?
Anonymous data will be shared by the principal investigator upon request via e-mail(temelguner@hotmail.com.tr)


What supporting documents are/will be available?




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.