NCT06844162

Brief Summary

Prospective observational cohort comparing analgesic efficacy of suprainguinal fascia iliaca block (SFIB) vs pericapsular nerve group block combined with lateral femoral cutaneous nerve block (PENG+LFCN) in primary total hip arthroplasty under general anesthesia (n=48). Outcomes include VAS pain at rest and with movement at 3, 12, 24, 48 h; morphine use (0-3, 3-12, 12-24, 24-48 h; total 0-48 h); quadriceps strength at 6 and 24 h; physiotherapy participation at 24 and 48 h; and adverse events within 48 h.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
Last Updated

August 26, 2025

Status Verified

August 1, 2025

Enrollment Period

2 months

First QC Date

February 19, 2025

Last Update Submit

August 25, 2025

Conditions

Keywords

Suprainguinal fascia iliaca blockPENG blockLateral femoral cutaneous nerve blockPostoperative analgesia

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale scores

    Postoperative Visual Analogue Scale scores ( Minimum of 0 and maximum of 10 with higher scores indicative of more severe pain) will be measured at rest and 45 degrees passive flexion at 3, 12, 24 and 48th hours postoperatively

    In the 48 hours following surgery

Secondary Outcomes (3)

  • Opioid consumption

    In the 48 hours following surgery

  • Quadriceps weakness

    In the 48 hours following surgery

  • Ability to perform physiotherapy

    In the 48 hours following surgery

Other Outcomes (1)

  • Adverse effects

    In the 48 hours following surgery

Study Arms (2)

SFIB

Patients undergoing THA who received ultrasound-guided SFIB with 0.25% bupivacaine 40 mL under the fascia iliaca with cranial spread.

PENG

Patients undergoing THA who received ultrasound-guided PENG (0.5% bupivacaine 15 mL) at the iliopubic eminence plus LFCN block (0.5% bupivacaine 5 mL) distal to the inguinal ligament.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

48 patients of American Society of Anesthesiologists physical status I-II between the age of 18 to 90 years who were scheduled to undergo primary Total hip arthroplasty with a diagnosis of coxarthrosis

You may qualify if:

  • Patients who are scheduled to undergo primary total hip arthroplasty with a diagnosis of coxarthosis

You may not qualify if:

  • Patients who have a history of neuropathy, patients with renal and hepatic insufficiency, patients with known coagulopathy, patients with a history of allergy to local anesthetics, patients with a history of inguinal surgery on the same side and patients with impaired mental status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University Hospitals

Ankara, 06230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

February 19, 2025

First Posted

February 25, 2025

Study Start

February 1, 2024

Primary Completion

April 15, 2024

Study Completion

April 15, 2024

Last Updated

August 26, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

Locations