Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001205426
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
23/07/2025
Date registered
Help: Date registered
31/10/2025
Date last updated
Help: Date last updated
31/10/2025
Date data sharing statement initially provided
Help: Data sharing statement date
31/10/2025
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of pericapsular nerve group block and modified 3-in-1 block on postoperative pain level and speed of recovery after total hip arthroplasty
Scientific title
Comparison of pericapsular nerve group block and modified 3-in-1 block on postoperative pain level and speed of recovery after total hip arthroplasty
Additional trial identifiers [1] 314699 0
None
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
total hip arthroplasty 337906 0
postoperative pain 337907 0
Condition category
Condition code
Anaesthesiology 334235 334235 0 0
Pain management
Injuries and Accidents 335220 335220 0 0
Fractures
Musculoskeletal 335221 335221 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
3-in-1 block consists of the administration of local anesthetic around the obturator nerve (10ml 0.25% levobupivacaine), femoral nerve (10ml 0,125% levobupivacaine) and lateral femoral cutaneous nerve (5ml 0.25%). The block will be performed by an anesthesiologist upon entry to the operating room, prior to spinal anesthesia.
Intervention code [1] 332019 0
Treatment: Surgery
Intervention code [2] 332378 0
Treatment: Drugs
Description of the comparator or control
The PENG (pericapsular nerve group) block involves the administration of local anesthetic adjacent to the superior pubic ramus (20 mL of 0.25% levobupivacaine) and around the lateral femoral cutaneous nerve (5 mL of 0.25%). The block will be performed by an anesthesiologist upon entry to the operating room, prior to spinal anesthesia.
Control group
Active

Outcomes
Primary outcome [1] 342277 0
The primary outcome is comparison of the frequency of additional analgesia requests between the two groups during the first 12 postoperative hours.
Timepoint [1] 342277 0
12 hours following the end of the surgery.
Secondary outcome [1] 450228 0
Pain scores at 3, 6, 9 and 12 hours postoperatively
Timepoint [1] 450228 0
3, 6, 9 and 12 hours following the end of the surgery.
Secondary outcome [2] 452292 0
Time from block administration to the first request for rescue analgesia.
Timepoint [2] 452292 0
12 hours following the end of the surgery.
Secondary outcome [3] 452294 0
Comparison of patient satisfaction with analgesia after first 12 postoperative hours.
Timepoint [3] 452294 0
12 hours postoperatively.

Eligibility
Key inclusion criteria
ASA status 1 to 3 patients scheduled for total hip arthroplasty.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
patient refusal
local anesthetic allergies
previous lumbosacral syndromen in medical history
patients taking chronic analgesic therapy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (randomizer.org website)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
18/03/2025
Date of last participant enrolment
Anticipated
24/12/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
100
Accrual to date
41
Final
Recruitment outside Australia
Country [1] 27251 0
Croatia
State/province [1] 27251 0
Zagreb

Funding & Sponsors
Funding source category [1] 319536 0
Self funded/Unfunded
Name [1] 319536 0
this is standard regional anesthesia technique; extra funding is not necessary
Country [1] 319536 0
Primary sponsor type
Individual
Name
Vedran Lokosek - Department for anesthesiology, intensive care and pain management, Sestre milosrdnice University Hospital Center
Address
Country
Croatia
Secondary sponsor category [1] 322037 0
None
Name [1] 322037 0
Address [1] 322037 0
Country [1] 322037 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317829 0
ethics committee; Sestre milosrdnice University Hospital Center
Ethics committee address [1] 317829 0
Ethics committee country [1] 317829 0
Croatia
Date submitted for ethics approval [1] 317829 0
05/07/2024
Approval date [1] 317829 0
10/09/2024
Ethics approval number [1] 317829 0

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

Contacts
Principal investigator
Name 142286 0
Dr Vedran Lokosek
Address 142286 0
Vinogradska cesta 29, 10000 Zagreb, Croatia; Department for anesthesiology, intensive care and pain management, Sestre milosrdnice University Hospital Center
Country 142286 0
Croatia
Phone 142286 0
+38598842821
Fax 142286 0
Email 142286 0
[email protected]
Contact person for public queries
Name 142287 0
Vedran Lokosek
Address 142287 0
Vedran Lokosek; Department for anesthesiology, intensive care and pain management, Sestre milosrdnice University Hospital Center, Vinogradska cesta 29, 10000 Zagreb, Croatia
Country 142287 0
Croatia
Phone 142287 0
+38598842821
Fax 142287 0
Email 142287 0
[email protected]
Contact person for scientific queries
Name 142288 0
Vedran Lokosek
Address 142288 0
Vedran Lokosek; Department for anesthesiology, intensive care and pain management, Sestre milosrdnice University Hospital Center, Vinogradska cesta 29, 10000 Zagreb, Croatia
Country 142288 0
Croatia
Phone 142288 0
+38598842821
Fax 142288 0
Email 142288 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    Lokošek - dopusnica Vinogradska.pdf
Informed consent form    Informirani pristanak KBCSM.docx


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.