NCT06342102

Brief Summary

Total hip arthroplasty is a major surgical procedure performed on a growing number of patients. Optimal pain control with limited muscle weakness is paramount for a swift initiation of physical therapy and ambulation, thus expediting hospital discharge. Amongst the many peripheral nerve blocks, FIB (fascia iliaca block) has been recommended as the block of choice by many international guidelines since it offers the best pain control with a relatively low risk of motor block. PENG (pericapsular nerve group) and its association with LFCN (lateral femoral cutaneous nerve) has been proposed as an effective alternative that offers comparable, If not better, pain control with a considerably lower risk for motor block compared to FIB. Given the novelty of this block, there are few published papers on the subject, mostly case series or case reports thus justifying the need for retrospective study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 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

First Submitted

Initial submission to the registry

March 26, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

March 26, 2024

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2024

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

6 days

First QC Date

March 26, 2024

Last Update Submit

March 18, 2025

Conditions

Keywords

PENGLFCNfascia iliacaTHAtotal hip replacement surgeryanalgesiamovementPeripheral nerve blocks

Outcome Measures

Primary Outcomes (1)

  • Movement of the lower limb affected by surgery

    The Medical Research Council (MRC) Muscle Strength Scale (ranging scale from 0 to 5 0= no visible contraction, 5=normal power) was used to assess the degree of residual quadriceps femoris muscle paresis 6 hours postoperatively.

    6 hours after surgery

Secondary Outcomes (6)

  • pain control

    6 hours after surgery

  • pain control

    12 hours after surgery

  • pain control

    24 hours after surgery

  • Morphine Milligram Equivalents (MME) of "pro re nata" (PRN) opioid doses

    24 hours after surgery

  • Morphine Milligram Equivalents (MME) of "pro re nata" (PRN) opioid doses

    6 hours after surgery

  • +1 more secondary outcomes

Other Outcomes (2)

  • time to first opioid request

    From date of surgery until up to 3 days after

  • time to first postoperative ambulation

    From date of surgery until up to 3 days after

Study Arms (2)

PENG + LFCN Block

group in which PENG + LFCN Block was performed

Procedure: PENG + LFCN block

FIC Block

group in which FIC Block was performed

Procedure: FIC block

Interventions

The PENG block was performed under ultrasound guidance. After skin disinfection, the needle was advanced between the psoas tendon and pubic ramus where 20 mL of 0.5% ropivacaine were injected. The LFCN block was performed following the PENG block.10 ml of 0.5% ropivacaine were injected near the nerve into the fat-filled flat tunnel (FFFT) located at the level of the superior anterior iliac spine and lateral to the sartorius muscle.

Also known as: pericapsular nerve group block associated with lateral femoral cutaneous nerve block
PENG + LFCN Block
FIC blockPROCEDURE

FICB was performed under ultrasound guidance. The needle was advanced above the fascia iliaca and 20 mL of 0.5% ropivacaine were injected

Also known as: fascia iliaca compartment block
FIC Block

Eligibility Criteria

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

Historical cohort study conducted among all patients who had THA from November 2022 to October 2023 at the ASST Nord Milano - Bassini Hospital, Cinisello Balsamo, Milano, Italy.

You may qualify if:

  • elective total hip replacement surgery for non-traumatic hip disease,
  • age over 18 years,
  • complete clinical chart including type of peripheral nerve block performed,
  • signed consent form for spinal anesthesia and peripheral nerve block.

You may not qualify if:

  • preoperative opioid therapy,
  • having received a peripheral nerve block other than PENG + LFCN or FICB,
  • having received general anesthesia,
  • incomplete chart,
  • documented muscle weakness
  • deviation from the established post-operative analgesia protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASST Nord Milano - Ospedale E. Bassini

Cinisello Balsamo, Italy/Milano, 20092, Italy

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

March 26, 2024

First Posted

April 2, 2024

Study Start

March 26, 2024

Primary Completion

April 1, 2024

Study Completion

April 30, 2024

Last Updated

March 19, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations