NCT05916209

Brief Summary

Background: Optimal pain control with limited muscle weakness is paramount for a swift initiation of physical therapy and ambulation. Fascia iliaca compartment block (FICB) has been recommended since it offers the best pain control with low risk of motor block. Pericapsular nerve group block (PENG) with lateral femoral cutaneous nerve (LFCN) block has been proposed as an effective alternative to FICB that offers similar pain control with a considerably lower risk of motor block. This study aimed to compare the afore mentioned blocks and determine which one yielded the lowest NRS score.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2023

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, 2023

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 23, 2023

Completed
Last Updated

June 23, 2023

Status Verified

June 1, 2023

Enrollment Period

28 days

First QC Date

May 19, 2023

Last Update Submit

June 13, 2023

Conditions

Keywords

total hip replacement surgeryprimary hip arthritis

Outcome Measures

Primary Outcomes (3)

  • pain control

    pain assessment with Numeric Rating Scale (NRS): a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

    6 hours after surgery

  • pain control

    pain assessment with Numeric Rating Scale (NRS): a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

    12 hours after surgery

  • pain control

    pain assessment with Numeric Rating Scale (NRS): a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

    24 hours after surgery

Secondary Outcomes (3)

  • MME of PRN opioid doses

    6 hours after surgery

  • MME of PRN opioid doses

    12 hours after surgery

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

    24 hours after surgery

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 100 days after

Study Arms (2)

PENG + LFCN Block

group in which PENG + LFCN Block was performed

Procedure: Peripheral nerve blocks

FIC Block

group in which FIC Block was performed

Procedure: Peripheral nerve blocks

Interventions

Peripheral nerve blocks provide intense, site-specific analgesia administring local anesthetics near the nerves.

FIC BlockPENG + LFCN Block

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

primary hip replacement surgery

You may qualify if:

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

You may not qualify if:

  • incomplete chart, a peripheral nerve block other than PENG or FIC block was performed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Edoardo Bassini

Cinisello Balsamo, Milano, 20092, Italy

Location

Related Publications (39)

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Study Design

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

Study Record Dates

First Submitted

May 19, 2023

First Posted

June 23, 2023

Study Start

February 1, 2023

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

June 23, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations