Regional Anesthesia BlockRetro-PvFNCT06342102
PENG and LFCN Block Versus FIC Block for Multimodal Analgesia After Total Hip Replacement Surgery: a Retrospective Analysis Focused on Movement (Retro-PvF)
An observational study of Regional Anesthesia Block and Regional Anesthesia, run by Ospedale Edoardo Bassini at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Regional Anesthesia Block, Regional Anesthesia, Total Hip Replacement Surgery
- What is being tested?
- PENG + LFCN block and FIC block
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 26 Mar 2024to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
ASST Nord Milano - Ospedale E. Bassini
Cinisello Balsamo, Italy/Milano, 20092
About this study
Official title: 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.
Read the 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.
- Conditions
- Regional Anesthesia Block, Regional Anesthesia, Total Hip Replacement Surgery, Total Hip Arthroplasty \(THA\)
- Being tested
- PENG + LFCN block, FIC block
- Keywords
- PENG, LFCN, fascia iliaca, THA, total hip replacement surgery, analgesia, movement, Peripheral nerve blocks
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENG + LFCN blockProcedure or surgery
Also called pericapsular nerve group block associated with lateral femoral cutaneous nerve block
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.
FIC blockProcedure or surgery
Also called fascia iliaca compartment block
FICB was performed under ultrasound guidance. The needle was advanced above the fascia iliaca and 20 mL of 0.5% ropivacaine were injected
| Study group | Role | What they receive |
|---|---|---|
| PENG + LFCN Block | group in which PENG + LFCN Block was performed Receives: Procedure: PENG + LFCN block | |
| FIC Block | group in which FIC Block was performed Receives: Procedure: FIC block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 hours after surgery
Secondary outcomes (6)
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"
Measured: 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"
Measured: 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"
Measured: 24 hours after surgery
Morphine Milligram Equivalents (MME) of "pro re nata" (PRN) opioid doses
we studied the effect of Regional anesthesia on opioid-sparing
Measured: 24 hours after surgery
Morphine Milligram Equivalents (MME) of "pro re nata" (PRN) opioid doses
we studied the effect of Regional anesthesia on opioid-sparing
Measured: 6 hours after surgery
Morphine Milligram Equivalents (MME) of "pro re nata" (PRN) opioid doses
we studied the effect of Regional anesthesia on opioid-sparing
Measured: 12 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start26 Mar 2024
- Primary completion1 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional Anesthesia BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Edoardo Bassini
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Vetrone, MD, Ospedale Edoardo Bassini
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06342102
- Sponsor's protocol ID
- ID 4286
- Acronym
- Retro-PvF
- Status last verified
- Mar 2025
- First submitted
- 26 Mar 2024
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06342102
- Acronym / sponsor ID
- Retro-PvF / ID 4286
- Conditions
- Regional Anesthesia Block, Regional Anesthesia, Total Hip Replacement Surgery, Total Hip Arthroplasty \(THA\)
- Keywords
- PENG, LFCN, fascia iliaca, THA, total hip replacement surgery, analgesia, movement, Peripheral nerve blocks
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ospedale Edoardo BassiniUniversity, hospital or other
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PENG + LFCN Block | – | Procedure: PENG + LFCN blockgroup in which PENG + LFCN Block was performed |
| FIC Block | – | Procedure: FIC blockgroup in which FIC Block was performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- preoperative opioid therapy,
- having received a peripheral nerve block other than PENG + LFCN or FICB,
- having received general anesthesia,
- incomplete chart,
- documented muscle weakness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PENG + LFCN blockAlso: pericapsular nerve group block associated with lateral femoral cutaneous nerve blockThe 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. | Procedure or surgery | PENG + LFCN Block |
| FIC blockAlso: fascia iliaca compartment blockFICB was performed under ultrasound guidance. The needle was advanced above the fascia iliaca and 20 mL of 0.5% ropivacaine were injected | Procedure or surgery | FIC Block |
Primary outcome
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 secondary outcomes
pain control
Time frame: 6 hours after surgery
pain control
Time frame: 12 hours after surgery
pain control
Time frame: 24 hours after surgery
Morphine Milligram Equivalents (MME) of "pro re nata" (PRN) opioid doses
Time frame: 24 hours after surgery
Morphine Milligram Equivalents (MME) of "pro re nata" (PRN) opioid doses
Time frame: 6 hours after surgery
Morphine Milligram Equivalents (MME) of "pro re nata" (PRN) opioid doses
Time frame: 12 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Regional Anesthesia Block and Regional Anesthesia, run by Ospedale Edoardo Bassini at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Movement of the lower limb affected by surgery (time frame: 6 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.