Regional Anesthesia MorbidityNCT06147401
Comparison of PENG Associated with LFCN Block Versus FICB for Multimodal Analgesic Management in THA
A study testing PENG plus LFCN block and FIC Block in people with Regional Anesthesia Morbidity and Arthropathy of Hip, run by Ospedale Edoardo Bassini at 1 site in Italy.
Trial summary
Optimal pain control with limited muscle weakness is paramount for a swift initiation of physical therapy and ambulation. Fascia iliaca compartment block (FIC) has been recommended since it offers the best pain control with low risk of motor block. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Regional Anesthesia Morbidity, Arthropathy of Hip, Hip Arthropathy
- What is being tested?
- PENG plus LFCN block and FIC Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteItaly
- Study dates
- 20 Nov 2023to 1 Jun 2024
- Phase
- Interventional
- 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
Who may be able to join
- elective total hip replacement surgery for non-traumatic hip disease,
- THA (total hip arthroplasty) with lateral approach
- age >18 years,
- signed consent form for spinal anesthesia and peripheral nerve block provided by the patient or legal guardian if appointed
Who cannot join
- Non elective THA
- Lack of consent to the procedure
- Contraindications to performing neuraxial anesthesia (i.e. Signs suggestive of puncture site infection, INR > 1.5, aPTT > 1.5, PLT < 40.000)
- Documented or suspected allergy to local anesthetics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pericapsular Nerve Group (PENG) Associated with Lateral Femoral Cutaneous Nerve (LFCN) Block Versus FIC Block for Total Hip Replacement Surgery: a Double Blind Randomized Controlled Trial
Optimal pain control with limited muscle weakness is paramount for a swift initiation of physical therapy and ambulation. Fascia iliaca compartment block (FIC) 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 block (LFCN) has been proposed as an effective alternative to FIB that offers similar pain control with a considerably lower risk of motor block. The aim of this study is to compare the afore mentioned blocks and determine which one yielded the least degree of quadriceps femoris muscle weakness and the better pain control (the lowest NRS score with least need for opioids).
Read the detailed description
This single-center, double blinded RCT investigation will be conducted at ASST Nord Milano - Bassini hospital. The study was approved by the ethics committee "Comitato Etico Territoriale Lombardia 3".
Each patient undergoing elective total hip replacement surgery with anterior approach will be subjected (unless contraindicated) to subarachnoid neuraxial anesthesia and immediately afterwards to a peripheral analgesic block: the FIC block or the association of PENG and FCLN block. The choice of block type will be randomized.
At the end of the procedure, a clinician unaware of the anesthetic technique used will assess the degree of residual motor block. Simultaneously, he will assess pain control in terms of NRS (Numerical Rating Scale) and the need for opioid use.
- Conditions
- Regional Anesthesia Morbidity, Arthropathy of Hip, Hip Arthropathy, Post Operative Pain, Anesthesia Complication
- Being tested
- PENG plus LFCN block, FIC Block
- Keywords
- ERAS, Postoperative muscle weakness, Regional Block, Post Operative Analgesia
- Medical subject headings
- Pain, Postoperative
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.
FIC BlockProcedure or surgery
Also called Fascia Iliaca Compartment Block, FICB
The control arm will be subjected to an interfascial block, the fascia iliaca Compartment Block.
The FICB consists in the injection of anaesthetic agents into the fascia iliaca compartment.
| 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 5ml of Ropivacaine 0.5% will be administered respectively. Receives: Procedure: PENG plus LFCN block |
| FIC Block | Active comparator | group in which FIC Block was performed After performing neuraxial anesthesia, FIC block will be performed. Under ultrasound guidance, 20 ml of Ropivacaine 0.5% will be administered. Receives: Procedure: FIC Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Secondary outcomes (7)
time to first postoperative ambulation
we studied the effect or Regional anesthesia on residual paralysis
Measured: From date of surgery until up to 72 hours after
Pain 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 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 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
MME of PRN opioid total doses
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 72 hours after
time to first PRN opioid request
time to first PRN (pro re nata) opioid request expressed in minutes
Measured: From date of surgery until up to 72 hours after
need for PRN opioid
number of opioid administration
Measured: From date of surgery until up to 72 hours after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start20 Nov 2023
- Primary completion1 May 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional Anesthesia MorbidityStudies 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
- 58 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
- NCT06147401
- Sponsor's protocol ID
- 3703
- Status last verified
- Dec 2024
- First submitted
- 17 Nov 2023
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pericapsular Nerve Group (PENG) Associated with Lateral Femoral Cutaneous Nerve (LFCN) Block Versus FIC Block for Total Hip Replacement Surgery: a Double Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06147401
- Acronym / sponsor ID
- 3703
- Conditions
- Regional Anesthesia Morbidity, Arthropathy of Hip, Hip Arthropathy, Post Operative Pain, Anesthesia Complication
- Keywords
- ERAS, Postoperative muscle weakness, Regional Block, Post Operative Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Ospedale Edoardo BassiniUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 27 Nov 2023 (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.
Optimal pain control with limited muscle weakness is paramount for a swift initiation of physical therapy and ambulation. Fascia iliaca compartment block (FIC) 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 block (LFCN) has been proposed as an effective alternative to FIB that offers similar pain control with a considerably lower risk of motor block. The aim of this study is to compare the afore mentioned blocks and determine which one yielded the least degree of quadriceps femoris muscle weakness and the better pain control (the lowest NRS score with least need for opioids).
Detailed description
This single-center, double blinded RCT investigation will be conducted at ASST Nord Milano - Bassini hospital. The study was approved by the ethics committee "Comitato Etico Territoriale Lombardia 3".
Each patient undergoing elective total hip replacement surgery with anterior approach will be subjected (unless contraindicated) to subarachnoid neuraxial anesthesia and immediately afterwards to a peripheral analgesic block: the FIC block or the association of PENG and FCLN block. The choice of block type will be randomized.
At the end of the procedure, a clinician unaware of the anesthetic technique used will assess the degree of residual motor block. Simultaneously, he will assess pain control in terms of NRS (Numerical Rating Scale) and the need for opioid use.
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 5ml of Ropivacaine 0.5% will be administered respectively. |
| FIC Block | Active comparator | Procedure: FIC Blockgroup in which FIC Block was performed After performing neuraxial anesthesia, FIC block will be performed. Under ultrasound guidance, 20 ml of Ropivacaine 0.5% will be administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- elective total hip replacement surgery for non-traumatic hip disease,
- THA (total hip arthroplasty) with lateral approach
- age >18 years,
- signed consent form for spinal anesthesia and peripheral nerve block provided by the patient or legal guardian if appointed
Key exclusion criteria (4 listed)
- Non elective THA
- Lack of consent to the procedure
- Contraindications to performing neuraxial anesthesia (i.e. Signs suggestive of puncture site infection, INR > 1.5, aPTT > 1.5, PLT < 40.000)
- Documented or suspected allergy to local anesthetics
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 |
| FIC BlockAlso: Fascia Iliaca Compartment Block, FICBThe control arm will be subjected to an interfascial block, the fascia iliaca Compartment Block. The FICB consists in the injection of anaesthetic agents into the fascia iliaca compartment. | Procedure or surgery | FIC Block |
Primary outcome
MRC at 6h
Time frame: six hours after performing the regional anesthesia technique
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".
MRC at 24h
Time frame: 24 hours after performing the regional anesthesia technique
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".
MRC at 48h
Time frame: 48 hours after performing the regional anesthesia technique
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".
7 secondary outcomes
time to first postoperative ambulation
Time frame: From date of surgery until up to 72 hours after
Pain control at 6h
Time frame: six hours after performing the regional anesthesia technique
Pain control at 24h
Time frame: 24 hours after performing the regional anesthesia technique
Pain control at 48h
Time frame: 48 hours after performing the regional anesthesia technique
MME of PRN opioid total doses
Time frame: From date of surgery until up to 72 hours after
time to first PRN opioid request
Time frame: From date of surgery until up to 72 hours after
need for PRN opioid
Time frame: From date of surgery until up to 72 hours after
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 18 Dec 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Regional Anesthesia Morbidity
Recruiting
Impact of Communication Delays on Anesthesia Response to Medical Emergencies and Ultrasound-Guided Regional Anesthesia
Regional Anesthesia, Regional Anesthesia Morbidity
Recruiting
Ketamine Versus Dexmedetomidine as an Adjuvant in Scalp Block in Supratentorial Brain Tumor Excision Surgeries
Regional Anesthesia Morbidity, Supratentorial Brain Tumor
Recruiting
Erector Spinae Block Versus Paravertebral Block on Chronic Pain After Mastectomy
Mastectomy; Lymphedema, Chronic Pain
Active, not recruitingObservational study
Retrospective Analysis of Pain After Nerve Block in Surgical Patients
Regional Anesthesia Morbidity, Acute Pain
Recruiting
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
Arthropathy of Hip, Hip Arthropathy
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?
A study testing PENG plus LFCN block and FIC Block in people with Regional Anesthesia Morbidity and Arthropathy of Hip, 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 4 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 18 Dec 2024. 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?
MRC at 6h (time frame: six hours after performing the regional anesthesia technique). The study lists 3 primary outcomes in all. 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 18 Dec 2024.