Arthropathy of HipPeng_lfcn/WINCT07284615
Pericapsular Nerve Group (PENG) Block Combined With Lateral Femoral Cutaneous Nerve (LFCN) Block or Wound Infiltration for Postoperative Analgesia in Anterior Approach Total Hip Arthroplasty: A Randomized Controlled Trial
A study testing PENG plus LFCN block and PENG plus WI in people with Arthropathy of Hip and Hip Arthropathy, run by Ospedale Edoardo Bassini at 1 site in Italy.
Trial summary
This prospective, randomized controlled trial aims to compare two multimodal regional anesthesia strategies for postoperative analgesia in elective total hip arthroplasty (THA) performed via anterior approach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthropathy of Hip, Hip Arthropathy, Locoregional Anesthesia
- What is being tested?
- PENG plus LFCN block and PENG plus WI
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteItaly
- Study dates
- 26 Jan 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age > 18 years
- Elective total hip arthroplasty
- Spinal (subarachnoid) anesthesia
- Written informed consent provided by the patient or by the legal guardian, if appointed
Who cannot join
- INR > 1.5
- aPTT > 1.5
- Platelet count < 75,000/mm³
- Signs suggestive of infection at the puncture site
- Absence of informed consent to the procedure
- Documented or suspected allergy to local anesthetics
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Ospedale Edoardo Bassini
Cinisello Balsamo, Milano, 20092
Matteo Coccolo, MD, +39025799 ext. 8271, matteo.coccolo@asst-nordmilano.it
Angelo Pezzi, MD, +39025799 ext. 8293, angelo.pezzi@asst-nordmilano.it
About this study
Official title: Lateral Femoral Cutaneous Nerve (LFCN) Block or Wound Infiltration (WI) Combined With Pericapsular Nerve Group (PENG) Block for Analgesia in Elective Anterior Approach Total Hip Arthroplasty: A Randomized Controlled Trial
This prospective, randomized controlled trial aims to compare two multimodal regional anesthesia strategies for postoperative analgesia in elective total hip arthroplasty (THA) performed via anterior approach. Patients will be randomized to receive either a Pericapsular Nerve Group (PENG) block combined with a Lateral Femoral Cutaneous Nerve (LFCN) block, or a PENG block combined with wound infiltration (WI).
The primary outcome is postoperative pain intensity at rest, measured by Numerical Rating Scale (NRS) at 6 hours after surgery. Secondary outcomes include dynamic pain scores at 6, 24, and 48 hours, total opioid consumption, time to first rescue analgesia, quadriceps strength, hip flexion angle, length of stay, and adverse events.
All procedures are routinely used in clinical practice and carry minimal additional risk. Safety will be continuously monitored by the Principal Investigator and the study team according to an internal Safety Monitoring Plan.
- Conditions
- Arthropathy of Hip, Hip Arthropathy, Locoregional Anesthesia, Complication of Anesthesia, Regional Anesthesia Morbidity, Hospital Stay, Length of Stay in Hospital From Time of Surgery Till Discharge
- Being tested
- PENG plus LFCN block, PENG plus WI
- Keywords
- Postoperative muscle weakness, ERAS, Regional Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENG plus LFCN blockProcedure or surgery
Also called Pericapsular nerve group block and lateral femoral cutaneous nerve block, PENG and lateral femoral cutaneous nerve block
The experimental arm will be subjected to a combination of peripheral blocks: the interfascial block of the PENG and the perinervous block of the LFCN The PENG block involves deposition of local anesthetic in the fascial plane between the psoas muscle and the superior pubic ramus. The LFCN block consists of applying local anesthetic near the nerve. The LFCN lies in the subcutaneous plane deep to the fascia lata below the anterior superior ischiatic spine.
PENG plus WIProcedure or surgery
Also called Pericapsular nerve group block and wound infiltration, PENG and WI
The control arm will receive a combination of pericapsular nerve group (PENG) block and wound infiltration (WI). The PENG block involves the deposition of local anesthetic in the fascial plane between the psoas tendon and the superior pubic ramus, under ultrasound guidance. The wound infiltration consists of the administration of local anesthetic into the subcutaneous tissue along the surgical incision
| Study group | Role | What they receive |
|---|---|---|
| PENG - LFCN Block | Experimental | group in which PENG and LFCN Block was performed. After performing neuraxial anesthesia, the PENG associated with LFCN block will be performed. Under ultrasound guidance, 20ml and 10ml of Ropivacaine 0.5% will be administered respectively Receives: Procedure: PENG plus LFCN block |
| PENG-WI | Active comparator | the group in which PENG and WI (wound infiltration) are performed, after neuraxial anesthesia, a PENG block will be administered under ultrasound guidance using 20 mL of 0.5% ropivacaine. At the end of the surgery, a wound infiltration will be performed with 10 mL of 0.5% ropivacaine. Receives: Procedure: PENG plus WI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain at rest control at 6h
pain assessment with Numeric Rating Scale (NRS): a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
Measured: six hours after performing the regional anesthesia technique
Secondary outcomes (15)
Pain at rest control at 24h
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 performing the regional anesthesia technique
Pain at rest control at 48h
pain assessment with Numeric Rating Scale (NRS): a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
Measured: 48 hours after performing the regional anesthesia technique
Pain on movement control at 6h
pain assessment with Numeric Rating Scale (NRS): a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
Measured: six hours after performing the regional anesthesia technique
Pain on movement control at 24h
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 performing the regional anesthesia technique
Pain on movement control at 48h
pain assessment with Numeric Rating Scale (NRS): a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
Measured: 48 hours after performing the regional anesthesia technique
MRC at 6h
evaluation of the degree of weakness or residual paresis of the quadriceps femoris muscle on the operative side using 'the Oxford Scale' (aka Medical Research Council Manual Muscle Testing scale or MRC scale) The MRC scale is a 0-5 scale, with zero meaning "no contraction " and five meaning "Full range of motion against gravity with full resistance".
Measured: six hours after performing the regional anesthesia technique
MRC at 24h
evaluation of the degree of weakness or residual paresis of the quadriceps femoris muscle on the operative side using 'the Oxford Scale' (aka Medical Research Council Manual Muscle Testing scale or MRC scale) The MRC scale is a 0-5 scale, with zero meaning "no contraction " and five meaning "Full range of motion against gravity with full resistance".
Measured: 24 hours after performing the regional anesthesia technique
MRC at 48h
evaluation of the degree of weakness or residual paresis of the quadriceps femoris muscle on the operative side using 'the Oxford Scale' (aka Medical Research Council Manual Muscle Testing scale or MRC scale) The MRC scale is a 0-5 scale, with zero meaning "no contraction " and five meaning "Full range of motion against gravity with full resistance".
Measured: 48 hours after performing the regional anesthesia technique
time to first PRN opioid request
Description: time to first PRN (pro re nata) opioid request expressed in minutes
Measured: Time Frame: From date of surgery until up to 48 hours after
MME of PRN opioid total doses
Description: Morphine Milligram Equivalents (MME) of "pro re nata" (PRN) opioid total doses we will study the effect of Regional anesthesia on opioid-sparing with the same pre-established pain relief protocol
Measured: From date of surgery until up to 48 hours after
Complication
any complications recorded in the first 48 hours including but not limited to: postoperative nausea and vomiting (PONV), vascular puncture, paresthesia and LA toxicity
Measured: From date of surgery until up to 48 hours after
the degree of hip flexion at 6h
Hip flexion degree of the operative side is measured using Digital Angle Gauge in supine position
Measured: six hours after performing the regional anesthesia technique
the degree of hip flexion at 24h
Hip flexion degree of the operative side is measured using Digital Angle Gauge in supine position
Measured: 24 hours after performing the regional anesthesia technique
the degree of hip flexion at 48h
Hip flexion degree of the operative side is measured using Digital Angle Gauge in supine position
Measured: 48 hours after performing the regional anesthesia technique
Length of Hospital Stay (LOS)
Length of hospital stay will be recorded as the number of postoperative midnights spent in the Orthopedic Ward, calculated from the day of surgery (postoperative day 0) until the date of discharge or death (exitus).
Measured: From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start26 Jan 2026
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthropathy of HipStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A double-blind, randomized, controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale Edoardo Bassini
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matteo Coccolo, Ospedale Edoardo Bassini
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07284615
- Sponsor's protocol ID
- 5967
- Acronym
- Peng_lfcn/WI
- Status last verified
- Mar 2026
- First submitted
- 19 Nov 2025
- Last updated
- 25 Mar 2026
- 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 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateral Femoral Cutaneous Nerve (LFCN) Block or Wound Infiltration (WI) Combined With Pericapsular Nerve Group (PENG) Block for Analgesia in Elective Anterior Approach Total Hip Arthroplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07284615
- Acronym / sponsor ID
- Peng_lfcn/WI / 5967
- Conditions
- Arthropathy of Hip, Hip Arthropathy, Locoregional Anesthesia, Complication of Anesthesia, Regional Anesthesia Morbidity, Hospital Stay, Length of Stay in Hospital From Time of Surgery Till Discharge
- Keywords
- Postoperative muscle weakness, ERAS, Regional Block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Ospedale Edoardo BassiniUniversity, hospital or other
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 16 Dec 2025 (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.
This prospective, randomized controlled trial aims to compare two multimodal regional anesthesia strategies for postoperative analgesia in elective total hip arthroplasty (THA) performed via anterior approach. Patients will be randomized to receive either a Pericapsular Nerve Group (PENG) block combined with a Lateral Femoral Cutaneous Nerve (LFCN) block, or a PENG block combined with wound infiltration (WI).
The primary outcome is postoperative pain intensity at rest, measured by Numerical Rating Scale (NRS) at 6 hours after surgery. Secondary outcomes include dynamic pain scores at 6, 24, and 48 hours, total opioid consumption, time to first rescue analgesia, quadriceps strength, hip flexion angle, length of stay, and adverse events.
All procedures are routinely used in clinical practice and carry minimal additional risk. Safety will be continuously monitored by the Principal Investigator and the study team according to an internal Safety Monitoring Plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A double-blind, randomized, controlled trial
| Arm | Type | Receives |
|---|---|---|
| PENG - LFCN Block | Experimental | Procedure: PENG plus LFCN blockgroup in which PENG and LFCN Block was performed. After performing neuraxial anesthesia, the PENG associated with LFCN block will be performed. Under ultrasound guidance, 20ml and 10ml of Ropivacaine 0.5% will be administered respectively |
| PENG-WI | Active comparator | Procedure: PENG plus WIthe group in which PENG and WI (wound infiltration) are performed, after neuraxial anesthesia, a PENG block will be administered under ultrasound guidance using 20 mL of 0.5% ropivacaine. At the end of the surgery, a wound infiltration will be performed with 10 mL of 0.5% ropivacaine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- Elective total hip arthroplasty
- Spinal (subarachnoid) anesthesia
- Written informed consent provided by the patient or by the legal guardian, if appointed
Key exclusion criteria (6 listed)
- INR > 1.5
- aPTT > 1.5
- Platelet count < 75,000/mm³
- Signs suggestive of infection at the puncture site
- Absence of informed consent to the procedure
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 plus LFCN blockAlso: Pericapsular nerve group block and lateral femoral cutaneous nerve block, PENG and lateral femoral cutaneous nerve blockThe experimental arm will be subjected to a combination of peripheral blocks: the interfascial block of the PENG and the perinervous block of the LFCN The PENG block involves deposition of local anesthetic in the fascial plane between the psoas muscle and the superior pubic ramus. The LFCN block consists of applying local anesthetic near the nerve. The LFCN lies in the subcutaneous plane deep to the fascia lata below the anterior superior ischiatic spine. | Procedure or surgery | PENG - LFCN Block |
| PENG plus WIAlso: Pericapsular nerve group block and wound infiltration, PENG and WIThe control arm will receive a combination of pericapsular nerve group (PENG) block and wound infiltration (WI). The PENG block involves the deposition of local anesthetic in the fascial plane between the psoas tendon and the superior pubic ramus, under ultrasound guidance. The wound infiltration consists of the administration of local anesthetic into the subcutaneous tissue along the surgical incision | Procedure or surgery | PENG-WI |
Primary outcome
Pain at rest control at 6h
Time frame: six hours after performing the regional anesthesia technique
pain assessment with Numeric Rating Scale (NRS): a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
15 secondary outcomes
Pain at rest control at 24h
Time frame: 24 hours after performing the regional anesthesia technique
Pain at rest control at 48h
Time frame: 48 hours after performing the regional anesthesia technique
Pain on movement control at 6h
Time frame: six hours after performing the regional anesthesia technique
Pain on movement control at 24h
Time frame: 24 hours after performing the regional anesthesia technique
Pain on movement control at 48h
Time frame: 48 hours after performing the regional anesthesia technique
MRC at 6h
Time frame: six hours after performing the regional anesthesia technique
MRC at 24h
Time frame: 24 hours after performing the regional anesthesia technique
MRC at 48h
Time frame: 48 hours after performing the regional anesthesia technique
time to first PRN opioid request
Time frame: Time Frame: From date of surgery until up to 48 hours after
MME of PRN opioid total doses
Time frame: From date of surgery until up to 48 hours after
Complication
Time frame: From date of surgery until up to 48 hours after
the degree of hip flexion at 6h
Time frame: six hours after performing the regional anesthesia technique
the degree of hip flexion at 24h
Time frame: 24 hours after performing the regional anesthesia technique
the degree of hip flexion at 48h
Time frame: 48 hours after performing the regional anesthesia technique
Length of Hospital Stay (LOS)
Time frame: From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PENG plus LFCN block and PENG plus WI in people with Arthropathy of Hip and Hip Arthropathy, 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: looking for participants now, as of the sponsor's last update on 25 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matteo Coccolo, MD (0039025799 ext. 8271, matteo.coccolo@asst-nordmilano.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain at rest control at 6h (time frame: six hours after performing the regional anesthesia technique). 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 25 Mar 2026.