ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Hip fracture

Condition category

Condition code

Anaesthesiology

Pain management

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

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]

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]

Pain

Timepoint [1]

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]

Quality of Position

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Turkey

State/province [1]

Istanbul

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Temel Guner

Address [1]

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital Non-Interventional Research Ethics Committee

Ethics committee address [1]

Emek Mahallesi, Namik Kemal Cad. No:54, 34785 Sancaktepe / Istanbul

Ethics committee country [1]

Turkey

Date submitted for ethics approval [1]

05/09/2024

Approval date [1]

18/09/2024

Ethics approval number [1]

2024/287

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Temel Güner

Address

Prof. Dr. Ilhan Varank Training and Research Hospital, Emek, Namik Kemal St.. No:54, 34785 Sancaktepe/Istanbul

Country

Turkey

Phone

+90 531 9241992

Fax

[email protected]

Contact person for public queries

Name

Temel Güner

Address

Prof. Dr. Ilhan Varank Training and Research Hospital, Emek, Namik Kemal St.. No:54, 34785 Sancaktepe/Istanbul

Country

Turkey

Phone

+90 531 9241992

Fax

[email protected]

Contact person for scientific queries

Name

Temel Güner

Address

Prof. Dr. Ilhan Varank Training and Research Hospital, Emek, Namik Kemal St.. No:54, 34785 Sancaktepe/Istanbul

Country

Turkey

Phone

+90 531 9241992

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• only researchers who provide a methodologically sound proposal

Conditions for requesting access:
• -

What individual participant data might be shared?

• Patient information will be made anonymous and all data will be shared.

What types of analyses could be done with individual participant data?

• Anonymous data will be available only for meta-analyses

When can requests for individual participant data be made (start and end dates)?

From:
Immediately following publication

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• Anonymous data will be shared by the principal investigator upon request via e-mail([email protected])

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
24280	Ethical approval					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.

Trial Review

Documents added manually

Documents added automatically