PainPENG-FLATNCT05432011
PENG Block Plus Lateral Femoral Cutaneous Nerve Block for Posterolateral-approached Total Hip Arthroplasty
A study testing PENG Block, Lateral Femoral Cutaneous Nerve Block and Wound Infiltration in people with Pain and Postoperative Pain, run by Campus Bio-Medico University at 1 site in Italy.
Trial summary
This study aims to analyze the effect of Pericapsular Nerve Group (PENG) Block combined with lateral femoral cutaneous nerve block vs. PENG block combined with wound infiltration for analgesia after elective hip replacement performed with a posters-lateral approach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative Pain, Acute Pain
- What is being tested?
- PENG Block, Lateral Femoral Cutaneous Nerve Block and Wound Infiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2022to 25 May 2023
- 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 hip replacement surgery performed with a poster-lateral approach
- ASA physical status score < 4
Who cannot join
- Contraindications to regional anesthesia
- ASA physical status score ≥ 4
- Patient's refusal or inability to sign the informed consent
- Allergies to any drug provided by the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PENG Block Combined to Lateral Femoral Cutaneous Nerve Block vs. PENG Block Combined to Wound Infiltration for Postoperative Analgesia Following Posterolateral-approached Total Hip Arthroplasty
This study aims to analyze the effect of Pericapsular Nerve Group (PENG) Block combined with lateral femoral cutaneous nerve block vs. PENG block combined with wound infiltration for analgesia after elective hip replacement performed with a posters-lateral approach.
Half of participants will receive a PENG Block combined with femoral lateral cutaneous nerve block, while the other half will receive PENG Block combined with wound infiltration
- Conditions
- Pain, Postoperative Pain, Acute Pain, Analgesia, Hip Arthropathy, Postoperative Complications
- Being tested
- PENG Block, Lateral Femoral Cutaneous Nerve Block, Wound Infiltration
- Medical subject headings
- Pain, Pain, Postoperative, Acute Pain, Agnosia, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENG BlockProcedure or surgery
At the end of surgery, in Post Anesthesia Recovery Room (PACU), PENG block with 20 mL of 0.5 % Ropivacaine will be executed as described by Giron-Arango et al. using a low frequency curvilinear probe. A 22G 80 mm needle (Stimuplex Ultra 360, B.Braun) will be used.
Lateral Femoral Cutaneous Nerve BlockProcedure or surgery
At the end of surgery, in Post Anesthesia Recovery Room (PACU), ultrasound guided Lateral Femoral Cutaneous Nerve Block will be performed with 10 mL of 0.5 % Ropivacaine using a high frequency linear probe. A 22G 50 mm needle (Stimuplex Ultra 360, B.Braun) will be used.
Wound InfiltrationProcedure or surgery
At the end of operation, the surgeon will perform wound infiltration with 20 mL of 0.5 % Ropivacaine.
| Study group | Role | What they receive |
|---|---|---|
| PENG block plus Femoral Cutaneous Nerve Block | Experimental | Participants receiving PENG block combined to Lateral Femoral Cutaneous Nerve Block Receives: Procedure: PENG Block; Procedure: Lateral Femoral Cutaneous Nerve Block |
| PENG block plus Wound Infiltration | Active comparator | Participants receiving PENG block combined to wound infiltration Receives: Procedure: PENG Block; Procedure: Wound Infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static Pain Score
A numerical rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain) will be used to evaluate pain at rest during 24 hours after surgery
Measured: 24 hours
Dynamic Pain Score
A numerical rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain) will be used to evaluate pain on movement during 24 hours after surgery
Measured: 24 hours
Secondary outcomes (8)
Morphine consumption
Total of intravenous morphine (expressed in milligrams) administered during the first 24 hours after surgery
Measured: 24 hours
Morphine consumption
Total of intravenous morphine (expressed in milligrams) administered during the entire hospitalization
Measured: 6 days
Range of hip motion
Degrees of hip flexion
Measured: 24 hours
Quadriceps Strength
Ability to flex the knee against gravity
Measured: 24 hours
Ability to start physiotherapy during the first postoperative day
YES: the patient was able to start physiotherapy NO: the patient was not able to start physiotherapy during the first postoperative day due to pain or motor block
Measured: 24 hours
Ability to ambulate with the help of a walker during the first postoperative day
YES: The patient was able to ambulate with the help of a walker NO: The patient was not able to ambulate with the help of a walker due to pain or motor block
Measured: 24 hours
Incidence of block complications
Any complications or side effects of the blocks, such as local infection, intravascular injection of local anesthetics and immediate systemic toxicity.
Moreover, incidence of nausea, vomiting and postoperative respiratory depression will be recorded
Measured: 24 hours
Hospital Length of Stay
Total Hospital length of Stay (expressed in days)
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start1 Jul 2022
- Primary completion18 May 2023
- Study completion25 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Pascarella, Campus Bio-Medico University
- Investigators
- Giuseppe Pascarella, MD, Principal investigator, University Hospital Campus Biomedico of Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05432011
- Sponsor's protocol ID
- PAR 34.22
- Acronym
- PENG-FLAT
- Status last verified
- Aug 2023
- First submitted
- 20 Jun 2022
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pascarella G, Costa F, Del Buono R, Pulitano R, Strumia A, Piliego C, De Quattro E, Cataldo R, Agro FE, Carassiti M; collaborators. Impact of the pericapsular nerve group (PENG) block on postoperative analgesia and functional recovery following total hip arthroplasty: a randomised, observer-masked, controlled trial. Anaesthesia. 2021 Nov;76(11):1492-1498. doi: 10.1111/anae.15536. Epub 2021 Jul 1.
PubMed 34196965Aliste J, Layera S, Bravo D, Jara A, Munoz G, Barrientos C, Wulf R, Branez J, Finlayson RJ, Tran Q. Randomized comparison between pericapsular nerve group (PENG) block and suprainguinal fascia iliaca block for total hip arthroplasty. Reg Anesth Pain Med. 2021 Oct;46(10):874-878. doi: 10.1136/rapm-2021-102997. Epub 2021 Jul 20.
PubMed 34290085Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
PubMed 30063657Del Buono R, Padua E, Pascarella G, Costa F, Tognu A, Terranova G, Greco F, Fajardo Perez M, Barbara E. Pericapsular nerve group block: an overview. Minerva Anestesiol. 2021 Apr;87(4):458-466. doi: 10.23736/S0375-9393.20.14798-9. Epub 2021 Jan 12.
PubMed 33432791
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PENG Block Combined to Lateral Femoral Cutaneous Nerve Block vs. PENG Block Combined to Wound Infiltration for Postoperative Analgesia Following Posterolateral-approached Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT05432011
- Acronym / sponsor ID
- PENG-FLAT / PAR 34.22
- Conditions
- Pain, Postoperative Pain, Acute Pain, Analgesia, Hip Arthropathy, Postoperative Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 18 May 2023 (actual)
- Study completion
- 25 May 2023 (actual)
- First posted
- 24 Jun 2022 (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 study aims to analyze the effect of Pericapsular Nerve Group (PENG) Block combined with lateral femoral cutaneous nerve block vs. PENG block combined with wound infiltration for analgesia after elective hip replacement performed with a posters-lateral approach.
Half of participants will receive a PENG Block combined with femoral lateral cutaneous nerve block, while the other half will receive PENG Block combined with wound infiltration
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PENG block plus Femoral Cutaneous Nerve Block | Experimental | Procedure: PENG Block, Procedure: Lateral Femoral Cutaneous Nerve BlockParticipants receiving PENG block combined to Lateral Femoral Cutaneous Nerve Block |
| PENG block plus Wound Infiltration | Active comparator | Procedure: PENG Block, Procedure: Wound InfiltrationParticipants receiving PENG block combined to wound infiltration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elective hip replacement surgery performed with a poster-lateral approach
- ASA physical status score < 4
Key exclusion criteria (4 listed)
- Contraindications to regional anesthesia
- ASA physical status score ≥ 4
- Patient's refusal or inability to sign the informed consent
- Allergies to any drug provided by the study protocol
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 BlockAt the end of surgery, in Post Anesthesia Recovery Room (PACU), PENG block with 20 mL of 0.5 % Ropivacaine will be executed as described by Giron-Arango et al. using a low frequency curvilinear probe. A 22G 80 mm needle (Stimuplex Ultra 360, B.Braun) will be used. | Procedure or surgery | PENG block plus Femoral Cutaneous Nerve Block, PENG block plus Wound Infiltration |
| Lateral Femoral Cutaneous Nerve BlockAt the end of surgery, in Post Anesthesia Recovery Room (PACU), ultrasound guided Lateral Femoral Cutaneous Nerve Block will be performed with 10 mL of 0.5 % Ropivacaine using a high frequency linear probe. A 22G 50 mm needle (Stimuplex Ultra 360, B.Braun) will be used. | Procedure or surgery | PENG block plus Femoral Cutaneous Nerve Block |
| Wound InfiltrationAt the end of operation, the surgeon will perform wound infiltration with 20 mL of 0.5 % Ropivacaine. | Procedure or surgery | PENG block plus Wound Infiltration |
Primary outcome
Static Pain Score
Time frame: 24 hours
A numerical rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain) will be used to evaluate pain at rest during 24 hours after surgery
Dynamic Pain Score
Time frame: 24 hours
A numerical rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain) will be used to evaluate pain on movement during 24 hours after surgery
8 secondary outcomes
Morphine consumption
Time frame: 24 hours
Morphine consumption
Time frame: 6 days
Range of hip motion
Time frame: 24 hours
Quadriceps Strength
Time frame: 24 hours
Ability to start physiotherapy during the first postoperative day
Time frame: 24 hours
Ability to ambulate with the help of a walker during the first postoperative day
Time frame: 24 hours
Incidence of block complications
Time frame: 24 hours
Hospital Length of Stay
Time frame: 6 days
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 30 Aug 2023.
- Results publication: PubMed 34196965Pascarella G, Costa F, Del Buono R, Pulitano R, Strumia A, Piliego C, De Quattro E, Cataldo R, Agro FE, Carassiti M; collaborators. Impact of the pericapsular nerve group (PENG) block on postoperative analgesia and functional recovery following total hip arthroplasty: a randomised, observer-masked, controlled trial. Anaesthesia. 2021 Nov;76(11):1492-1498. doi: 10.1111/anae.15536. Epub 2021 Jul 1.
- Results publication: PubMed 34290085Aliste J, Layera S, Bravo D, Jara A, Munoz G, Barrientos C, Wulf R, Branez J, Finlayson RJ, Tran Q. Randomized comparison between pericapsular nerve group (PENG) block and suprainguinal fascia iliaca block for total hip arthroplasty. Reg Anesth Pain Med. 2021 Oct;46(10):874-878. doi: 10.1136/rapm-2021-102997. Epub 2021 Jul 20.
- Results publication: PubMed 30063657Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
- Results publication: PubMed 33432791Del Buono R, Padua E, Pascarella G, Costa F, Tognu A, Terranova G, Greco F, Fajardo Perez M, Barbara E. Pericapsular nerve group block: an overview. Minerva Anestesiol. 2021 Apr;87(4):458-466. doi: 10.23736/S0375-9393.20.14798-9. Epub 2021 Jan 12.
- 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.
Giuseppe Pascarella, MD principal investigator
University Hospital Campus Biomedico of Rome
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 Block, Lateral Femoral Cutaneous Nerve Block and Wound Infiltration in people with Pain and Postoperative Pain, run by Campus Bio-Medico University 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 2 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 30 Aug 2023. 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?
Static Pain Score (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05432011, which also lists 4 linked publications.
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 30 Aug 2023.