- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06342102
PENG and LFCN Block Versus FIC Block for Multimodal Analgesia After Total Hip Replacement Surgery: a Retrospective Analysis Focused on Movement (Retro-PvF) (Retro-PvF)
April 2, 2024 updated by: Francesco Vetrone, Ospedale Edoardo Bassini
Pericapsular Nerve Group (PENG) Block and Lateral Femoral Cutaneous Nerve (LFCN) Block Versus Fascia Iliaca (FIC) Block for Multimodal Analgesia After Total Hip Replacement Surgery: a Retrospective Analysis Focused on Movement (Retro- PvF)
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
The primary outcome was the degree of residual quadriceps femoris muscle paresis assessed with the MRC (medical research council) scale at 6 hours between PENG and LCFN.
The secondary outcomes were NRS (numeric rating scale) at 6,12, 24 hours, total opioid consumption expressed as milligrams of morphine equivalents (MME), time to first rescue opioid and time to first postoperative ambulation.
Study Type
Observational
Enrollment (Estimated)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Francesco Vetrone, MF
- Phone Number: 8271 0039 025799
- Email: francesco.vetrone@asst-nordmilano.it
Study Contact Backup
- Name: Angelo Pezzi, MD
- Phone Number: 8293 0039 025799
- Email: angelo.pezzi@asst-nordmilano.it
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability 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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
PENG + LFCN Block
group in which PENG + LFCN Block was performed
|
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.
Other Names:
|
FIC Block
group in which FIC Block was performed
|
FICB was performed under ultrasound guidance.
The needle was advanced above the fascia iliaca and 20 mL of 0.5% ropivacaine were injected
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Movement of the lower limb affected by surgery
Time Frame: 6 hours after 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pain control
Time Frame: 6 hours after surgery
|
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
Time Frame: 12 hours after surgery
|
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
Time Frame: 24 hours after surgery
|
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
|
Morphine Milligram Equivalents (MME) of "pro re nata" (PRN) opioid doses
Time Frame: 24 hours after surgery
|
we studied the effect of Regional anesthesia on opioid-sparing
|
24 hours after surgery
|
Morphine Milligram Equivalents (MME) of "pro re nata" (PRN) opioid doses
Time Frame: 6 hours after surgery
|
we studied the effect of Regional anesthesia on opioid-sparing
|
6 hours after surgery
|
Morphine Milligram Equivalents (MME) of "pro re nata" (PRN) opioid doses
Time Frame: 12 hours after surgery
|
we studied the effect of Regional anesthesia on opioid-sparing
|
12 hours after surgery
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
time to first opioid request
Time Frame: From date of surgery until up to 3 days after
|
we studied the effect of Regional anesthesia on opioid-sparing
|
From date of surgery until up to 3 days after
|
time to first postoperative ambulation
Time Frame: From date of surgery until up to 3 days after
|
we studied the effect of Regional anesthesia on opioid-sparing
|
From date of surgery until up to 3 days after
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 26, 2024
Primary Completion (Estimated)
March 26, 2024
Study Completion (Estimated)
April 30, 2024
Study Registration Dates
First Submitted
March 26, 2024
First Submitted That Met QC Criteria
March 26, 2024
First Posted (Actual)
April 2, 2024
Study Record Updates
Last Update Posted (Actual)
April 4, 2024
Last Update Submitted That Met QC Criteria
April 2, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ID 4286
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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