NCT07153575

Brief Summary

The goal of this clinical trial is to compare analgesic effectiveness of two blocks in hip arthroplasty. The main question that aim to answer is;

  • Which block is more efficient? Researchers will compare suprainguinal fascia iliaca block with perineural nerve group block. Participants will randomized and one of the blocks will be applied.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 4, 2025

Completed
Last Updated

September 4, 2025

Status Verified

August 1, 2025

Enrollment Period

6 months

First QC Date

May 3, 2025

Last Update Submit

August 30, 2025

Conditions

Hip FracturesPost Operative PainPostoperative Nausea and Vomiting

Keywords

Hip ArthroplastyPostoperative analgesiaSuprainguinal fascia iliaca blockPericapsular nerve group block

Outcome Measures

Primary Outcomes (1)

  • To compare the postoperative analgesic efficacy of SFIB and PENG block

    Calculating total morphine consumption over 24 hours in patients by using patient controlled analgesia pump.

    24 hours

Secondary Outcomes (2)

  • Postoperative analgesia scores

    24 hours

  • Assessment of nausea and vomiting incidence

    24 hours

Other Outcomes (1)

  • Satisfaction levels

    24 hour

Study Arms (2)

Suprainguinal fascia iliaca block

ACTIVE COMPARATOR

The ultrasound-guided suprainguinal fascia iliaca block (SFIB) procedure was first described by Hebbard et al. in 2011. It is a prevalent regional anesthesia technique employed in surgical procedures involving the hip joint and femur. Local anesthetics are administered in close proximity to the fascia iliaca. The primary objective is to obstruct the femoral, obturator and lateral femoral cutaneous nerve in a simultaneous manner. In clinical practice, it is a safe and simple alternative to lumbar plexus blocks and femoral blocks. A 30-ml solution of 0.25% bupivacaine was injected between the iliac muscle and the iliac fascia. The bupivacaine dosage administered in the study was standardized for the groups by employing equal concentrations and volumes.

Procedure: suprainguinal fascia iliaca block

Pericapsular nerve group block

ACTIVE COMPARATOR

In pericapsular nerve group (PENG) block the local anesthetic agent is injected into the musculofascial plane between the psoas muscle tendon and the pubic ramus. The primary objective of this technique is to obstruct the genicular branches of the femoral, obturator, and accessory obturator which innervate the hip capsule. Therefore, a comparison with the SFIB was undertaken. A 30-ml block of 0.25% bupivacaine solution was injected between the pubic ramus and the iliopsoas muscle tendon. The bupivacaine dosage administered in the study was standardized for the groups by employing equal concentrations and volumes.

Procedure: Pericapsular nerve group (PENG) block

Interventions

suprainguinal fascia iliaca blockPROCEDURE

The ultrasound-guided suprainguinal fascia iliaca block (SFIB) procedure was first described by Hebbard et al. in 2011. It is a prevalent regional anesthesia technique employed in surgical procedures involving the hip joint and femur. Local anesthetics are administered in close proximity to the fascia iliaca. The primary objective is to obstruct the femoral, obturator and lateral femoral cutaneous nerve in a simultaneous manner. In clinical practice, it is a safe and simple alternative to lumbar plexus blocks and femoral blocks. A 30-ml solution of 0.25% bupivacaine was injected between the iliac muscle and the iliac fascia. The bupivacaine dosage administered in the study was standardized for the groups by employing equal concentrations and volumes.

Suprainguinal fascia iliaca block
Pericapsular nerve group (PENG) blockPROCEDURE

In pericapsular nerve group (PENG) block the local anesthetic agent is injected into the musculofascial plane between the psoas muscle tendon and the pubic ramus. The primary objective of this technique is to obstruct the genicular branches of the femoral, obturator, and accessory obturator which innervate the hip capsule. Therefore, a comparison with the SFIB was undertaken. A 30-ml block of 0.25% bupivacaine solution was injected between the pubic ramus and the iliopsoas muscle tendon. The bupivacaine dosage administered in the study was standardized for the groups by employing equal concentrations and volumes.

Pericapsular nerve group block

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteer patients undergoing hip arthroplasty
  • Voluntary patient to undergo elective operation under regional anaesthesia
  • ASA I-II-III
  • BMI≤35 kg/m²

You may not qualify if:

  • Obstacles to the application of regional anaesthesia
  • Local Anaesthetic Allergy
  • Coagulopathy
  • Psychiatric disorders and medication
  • Hematological/Oncological disease
  • Severe organ failure
  • Multiple bone fractures
  • Alcohol/Drug addiction
  • Used analgesic medication up to 12 hours before surgery
  • Infection at the Block Application Site
  • Mental Deficiency
  • Morbidly obese patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balikesir University

Balıkesir, 10140, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Hip FracturesPain, PostoperativePostoperative Nausea and Vomiting

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsNauseaSigns and Symptoms, DigestiveVomiting

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Fatih Ugün, M.D.

    Balikesir University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, MD

Study Record Dates

First Submitted

May 3, 2025

First Posted

September 4, 2025

Study Start

December 1, 2023

Primary Completion

May 31, 2024

Study Completion

August 31, 2025

Last Updated

September 4, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

All collected IPD throughout the trial will be shared.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Beginning 1 year after the publication of results
Access Criteria
All study data and analysis stages will be shared with interested researchers 1 year after the study is published.

Locations

TU(1)