Hip FracturesPENG 360°NCT07239817
PENG Block + LIA For Endoprosthesis Surgery
A study testing Pericapsular Nerve Group Blocks with Local Infiltration Analgesia and spinal anesthesia in people with Hip Fractures and Arthroplasty, Replacement, Hip, run by ASST Gaetano Pini-CTO at 1 site in Italy.
Trial summary
The goal of this clinical trial is to learn if a new local anesthesia technique can control pain as well as the standard spinal anesthesia for adults having hip endoprosthesis surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fractures, Arthroplasty, Replacement, Hip, Pain, Postoperative
- What is being tested?
- Pericapsular Nerve Group Blocks with Local Infiltration Analgesia and spinal anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 9 Dec 2025to 28 Feb 2027
- 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
- Provision of signed and dated informed consent form.
- Scheduled for hip endoprosthesis surgery for femoral fracture with an anterior, lateral or posterolateral approach (any approach).
- Age 18 years or older.
- Willing and able to comply with the study protocol.
Who cannot join
- Failure to provide informed consent.
- Age less than 18 years.
- Known allergy to local anesthetics or other medications used in the protocol.
- Presence of infection at the planned injection site.
- Pre-existing hip prosthesis or prior major surgery on the same hip (e.g., revision surgery).
- ASA physical status class > IV.
- Administration of intraoperative opiates or conversion to general anesthesia.
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
Gaetano Pini-CTO
Milan, 20122
Romualdo Del Buono, MD, +39 02 5829 6592, romualdo.delbuono@asst-pini-cto.it
About this study
Official title: PENG 360°: PENG Block + LIA Nella Endoprotesi di Anca.
The goal of this clinical trial is to learn if a new local anesthesia technique can control pain as well as the standard spinal anesthesia for adults having hip endoprosthesis surgery. The main questions it aims to answer are:
- Is the new local anesthesia technique as effective as standard spinal anesthesia in managing pain during the first two days after surgery?
- Does the new technique allow participants to move their leg sooner after the operation?
Read more
Researchers will compare the new local anesthesia technique (numbing medicine injected directly around the hip joint) to standard spinal anesthesia (a numbing injection in the back) to see if the new technique works just as well for pain control while possibly causing fewer side effects like nausea.
Participants who join this study will be randomly placed into one of two groups.
One group will receive the standard spinal anesthesia before their surgery.
The other group will receive the new local anesthesia technique before their surgery.
After the operation, researchers will track the amount of extra pain medicine each participant uses and will check their ability to move their hip, knee, and foot.
Read the detailed description
Study Rationale Standard anesthetic techniques for hip fracture surgery in the target population, which often includes fragile and elderly individuals, present distinct challenges. Both neuraxial (spinal) and general anesthesia can have a significant hemodynamic impact. Furthermore, traditional regional anesthetic techniques like lumbar plexus or femoral nerve blocks, while providing effective analgesia, often result in significant motor and sensory blockade of the lower limb, which can impede early mobilization and rehabilitation.
This study investigates a motor-sparing anesthetic approach. The intervention is based on pericapsular nerve group blocks (A-PENG and PONG), anterior and posterior, which target only the sensory articular branches innervating the hip capsule. This technique, combined with local infiltration analgesia (LIA), aims to provide comprehensive surgical anesthesia and post-operative analgesia without affecting motor function, thereby facilitating immediate post-operative mobilization.
Anesthetic Intervention Details (PENG 360° Arm) Participants randomized to the investigational arm will receive a combination of three injections prior to surgical incision. A convex ultrasound probe will be used for A-PENG and PONG.
- Anterior A-PENG Block: An injection of 20 mL of "plain" anesthetic solution is administered into the fascial plane between the iliopsoas muscle and the hip joint capsule. This solution consists of 10 mL of 0.75% ropivacaine, 10 mL of 2% mepivacaine with 1:200,000 epinephrine, and 2 mg of dexamethasone.
- Local Infiltration Analgesia (LIA): An injection of 20 mL of "diluted" anesthetic solution is used to infiltrate the planned incision line and subcutaneous tissue. This solution consists of 5 mL of 0.75% ropivacaine, 5 mL of 2% mepivacaine with 1:200,000 epinephrine, 1 mg of dexamethasone, and 10 mL of normal saline.
- Posterior PONG Block: With the participant in the lateral decubitus position, an injection of 10 mL of "plain" anesthetic solution is administered into the fascial plane deep to the quadratus femoris muscle. This solution consists of 5 mL of 0.75% ropivacaine, 5 mL of 2% mepivacaine with 1:200,000 epinephrine, and 1 mg of dexamethasone.
During surgery, participants in this arm will receive supplemental oxygen and sedation with propofol, with the depth of anesthesia monitored using a Bispectral Index (BIS) monitor.
Post-operative Pain Management Protocol To ensure a standardized approach to analgesia for all participants in both study arms, a uniform post-operative pain management protocol will be implemented. Unless contraindicated, all participants will receive a fixed-dose regimen of intravenous paracetamol (1000 mg) and ketorolac (30 mg) every 8 hours.
In addition, all participants will be provided with an intravenous patient-controlled analgesia (PCA) pump delivering morphine. The PCA pump will be set to deliver on-demand rescue boluses of 2 mg of morphine with no continuous background infusion. The maximum daily dose will be limited to 10 mg for participants over 65 years of age and 20 mg for those 65 or younger.
Data Management and Randomization Participant data will be collected and managed using an electronic Case Report Form (CRF) built with Google Forms and stored in a secure cloud database (Google Sheets). All data will be pseudonymized using a unique alphanumeric identifier assigned at the time of enrollment to ensure participant confidentiality.
Randomization will be performed using a dedicated Google Form configured to provide response options in a random order. The investigator will select the first option presented to assign the participant to either the "case" or "control" group19.
Statistical Analysis Plan Descriptive statistics (mean, median, standard deviation, min/max) will be used to summarize the collected data. The primary endpoint (cumulative number of PCA rescue doses at 48 hours) will be analyzed using a Poisson distribution model.
For other outcomes, a Chi-square test will be used for categorical variables (e.g., need for conversion to general anesthesia), while a t-test (or a non-parametric equivalent) will be used for continuous variables (e.g., NRS pain scores in the recovery room). Analysis of covariance and multiple linear regression may also be conducted to evaluate the role of demographic and clinical characteristics on study outcomes.
- Conditions
- Hip Fractures, Arthroplasty, Replacement, Hip, Pain, Postoperative, Anesthesia and Analgesia, Nerve Block, Local Anesthesia Infiltration
- Being tested
- Pericapsular Nerve Group Blocks with Local Infiltration Analgesia, spinal anesthesia
- Keywords
- Pericapsular Nerve Group Block, PENG block, Local Infiltration Analgesia, Spinal Anesthesia, Hip Arthroplasty, Postoperative Pain, Femoral Fractures, Ultrasound Guidance, Early Mobilization
- Medical subject headings
- Hip Fractures, Pain, Postoperative, Agnosia, Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pericapsular Nerve Group Blocks with Local Infiltration AnalgesiaProcedure or surgery
Also called PENG 360°; A-PENG +PONG +LIA
An ultrasound-guided, motor-sparing regional anesthesia procedure. It involves three distinct injections: 1) An anterior Pericapsular Nerve Group (A-PENG) block targeting the sensory articular branches of the femoral and obturator nerves. 2) A Local Infiltration Analgesia (LIA) of the surgical incision line. 3) A posterior PENG (PONG) block targeting sensory branches from the sciatic plexus. The local anesthetic mixture consists of ropivacaine, mepivacaine with epinephrine, and dexamethasone in specific volumes for each injection site.
spinal anesthesiaProcedure or surgery
Also called Spinal Block; Subarachnoid Block
Standard neuraxial anesthesia technique involving the injection of a local anesthetic into the subarachnoid space. The procedure is performed according to the institution's standard clinical practice. The choice of the specific local anesthetic agent, dose, and technique will be at the discretion of the attending anesthesiologist, based on the participant's clinical characteristics.
| Study group | Role | What they receive |
|---|---|---|
| PENG 360° | Experimental | Participants assigned to this arm will receive a motor-sparing anesthetic technique. This consists of three ultrasound-guided injections performed before surgery: an anterior Pericapsular Nerve Group (PENG) block, a Local Infiltration Analgesia (LIA) of the incision line, and a posterior PENG (PONG) block. Receives: Procedure: Pericapsular Nerve Group Blocks with Local Infiltration Analgesia |
| Spinal | Active comparator | Participants assigned to this arm will receive standard spinal anesthesia. The procedure will be performed according to the center's standard practice and guidelines, with the choice of local anesthetic and dosage at the discretion of the anesthesiologist Receives: Procedure: spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Postoperative Analgesic Rescue Doses
The cumulative number of on-demand analgesic doses (2 mg morphine bolus) requested by the participant via an intravenous Patient-Controlled Analgesia (PCA) pump. The total number of requests will be recorded from the pump's memory at 48 hours postoperatively. This is the primary measure for assessing postoperative pain control.
Measured: From arrival in the Post-Anesthesia Care Unit (PACU) up to 48 hours after surgery.
Secondary outcomes (4)
Immediate Postoperative Limb Mobility
Assessment of motor function in the operated limb. A binary (Yes/No) assessment will be made of the participant's ability to actively move their hip, knee, and foot.
Measured: Upon arrival in the Post-Anesthesia Care Unit (PACU), approximately 0-1 hours after surgery.
Incidence of Postoperative Nausea and Vomiting (PONV)
The occurrence of any episode of nausea or vomiting as reported by the participant or observed by clinical staff will be recorded.
Measured: Within the first 48 hours after surgery.
Postoperative Pain Intensity
Participant's self-reported pain intensity will be measured using the Numerical Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable.
Measured: Upon arrival in the Post-Anesthesia Care Unit (PACU), approximately 0-1 hours after surgery.
Length of Hospital Stay
The total number of days from the day of surgery to the day of discharge from the hospital, which is an indirect measure of recovery.
Measured: From the date of surgery until date of hospital discharge, assessed up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start9 Dec 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ASST Gaetano Pini-CTO
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romualdo Del Buono, ASST Gaetano Pini-CTO
- Investigators
- Romualdo Del Buono, MD, Principal investigator, Unit of Anesthesia, Intensive Care and Pain Management, ASST Gaetano Pini, Milan, Italy;
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239817
- Sponsor's protocol ID
- 5680 _SA_09.02.2026_P
- Acronym
- PENG 360°
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan Description Individual Participant Data (IPD) that will be shared: The full, de-identified participant dataset. The final study protocol. The statistical analysis plan. How to access the data: Data will be available to qualified researchers for non-commercial, academic purposes upon reasonable request. Interested researchers should submit a formal proposal outlining their research goals to the Principal Investigator. Data sharing timeline: Data will be made available after the publication of the primary study results and will remain available for a period of 5 years.
Publications
Del Buono R, Pascarella G, Costa F, Barbara E. Ultrasound-guided local infiltration analgesia for hip surgery: myth or reality? Minerva Anestesiol. 2019 Nov;85(11):1242-1243. doi: 10.23736/S0375-9393.19.13701-7. Epub 2019 May 21. No abstract available.
PubMed 31124626Del 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 33432791Del Buono R, Pascarella G, Padua E, Costa F, Tognu A, Terranova G, Greco F, Fajardo Perez M, Barbara E. PENG block: from standard to unconventional approaches. Minerva Anestesiol. 2021 Oct;87(10):1157-1158. doi: 10.23736/S0375-9393.21.15847-X. Epub 2021 Jul 14. No abstract available.
PubMed 34263587Del Buono R, Padua E, Pascarella G, Costa F, Tognu A, Terranova G, Greco F, Fajardo Perez M, Barbara E. Reply to: Tips for pericapsular nerve group (PENG) neurolytic blocks. Minerva Anestesiol. 2021 Oct;87(10):1151-1152. doi: 10.23736/S0375-9393.21.16019-5. Epub 2021 Aug 2. No abstract available.
PubMed 34337929Del Buono R, Padua E, Pascarella G, Costa F, Tognu A, Terranova G, Greco F, Fajardo Perez M, Barbara E. Pericapsular hip radiofrequency: future approaches to treat hip chronic pain. Minerva Anestesiol. 2021 Dec;87(12):1393-1394. doi: 10.23736/S0375-9393.21.16081-X. Epub 2021 Sep 16. No abstract available.
PubMed 34527412Del Buono R, Tognu A. Hip replacement using pericapsular nerve blocks in a high-risk patient. Minerva Anestesiol. 2024 Nov;90(11):1052-1054. doi: 10.23736/S0375-9393.24.18242-9. Epub 2024 Jul 9. No abstract available.
PubMed 38980297Giron-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 30063657
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PENG 360°: PENG Block + LIA Nella Endoprotesi di Anca.
- ClinicalTrials.gov ID
- NCT07239817
- Acronym / sponsor ID
- PENG 360° / 5680 _SA_09.02.2026_P
- Conditions
- Hip Fractures, Arthroplasty, Replacement, Hip, Pain, Postoperative, Anesthesia and Analgesia, Nerve Block, Local Anesthesia Infiltration
- Keywords
- Pericapsular Nerve Group Block, PENG block, Local Infiltration Analgesia, Spinal Anesthesia, Hip Arthroplasty, Postoperative Pain, Femoral Fractures, Ultrasound Guidance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- ASST Gaetano Pini-CTOUniversity, hospital or other
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 20 Nov 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.
The goal of this clinical trial is to learn if a new local anesthesia technique can control pain as well as the standard spinal anesthesia for adults having hip endoprosthesis surgery. The main questions it aims to answer are:
- Is the new local anesthesia technique as effective as standard spinal anesthesia in managing pain during the first two days after surgery?
- Does the new technique allow participants to move their leg sooner after the operation?
Researchers will compare the new local anesthesia technique (numbing medicine injected directly around the hip joint) to standard spinal anesthesia (a numbing injection in the back) to see if the new technique works just as well for pain control while possibly causing fewer side effects like nausea.
Participants who join this study will be randomly placed into one of two groups.
One group will receive the standard spinal anesthesia before their surgery.
The other group will receive the new local anesthesia technique before their surgery.
After the operation, researchers will track the amount of extra pain medicine each participant uses and will check their ability to move their hip, knee, and foot.
Detailed description
Study Rationale Standard anesthetic techniques for hip fracture surgery in the target population, which often includes fragile and elderly individuals, present distinct challenges. Both neuraxial (spinal) and general anesthesia can have a significant hemodynamic impact. Furthermore, traditional regional anesthetic techniques like lumbar plexus or femoral nerve blocks, while providing effective analgesia, often result in significant motor and sensory blockade of the lower limb, which can impede early mobilization and rehabilitation.
This study investigates a motor-sparing anesthetic approach. The intervention is based on pericapsular nerve group blocks (A-PENG and PONG), anterior and posterior, which target only the sensory articular branches innervating the hip capsule. This technique, combined with local infiltration analgesia (LIA), aims to provide comprehensive surgical anesthesia and post-operative analgesia without affecting motor function, thereby facilitating immediate post-operative mobilization.
Anesthetic Intervention Details (PENG 360° Arm) Participants randomized to the investigational arm will receive a combination of three injections prior to surgical incision. A convex ultrasound probe will be used for A-PENG and PONG.
- Anterior A-PENG Block: An injection of 20 mL of "plain" anesthetic solution is administered into the fascial plane between the iliopsoas muscle and the hip joint capsule. This solution consists of 10 mL of 0.75% ropivacaine, 10 mL of 2% mepivacaine with 1:200,000 epinephrine, and 2 mg of dexamethasone.
- Local Infiltration Analgesia (LIA): An injection of 20 mL of "diluted" anesthetic solution is used to infiltrate the planned incision line and subcutaneous tissue. This solution consists of 5 mL of 0.75% ropivacaine, 5 mL of 2% mepivacaine with 1:200,000 epinephrine, 1 mg of dexamethasone, and 10 mL of normal saline.
- Posterior PONG Block: With the participant in the lateral decubitus position, an injection of 10 mL of "plain" anesthetic solution is administered into the fascial plane deep to the quadratus femoris muscle. This solution consists of 5 mL of 0.75% ropivacaine, 5 mL of 2% mepivacaine with 1:200,000 epinephrine, and 1 mg of dexamethasone.
During surgery, participants in this arm will receive supplemental oxygen and sedation with propofol, with the depth of anesthesia monitored using a Bispectral Index (BIS) monitor.
Post-operative Pain Management Protocol To ensure a standardized approach to analgesia for all participants in both study arms, a uniform post-operative pain management protocol will be implemented. Unless contraindicated, all participants will receive a fixed-dose regimen of intravenous paracetamol (1000 mg) and ketorolac (30 mg) every 8 hours.
In addition, all participants will be provided with an intravenous patient-controlled analgesia (PCA) pump delivering morphine. The PCA pump will be set to deliver on-demand rescue boluses of 2 mg of morphine with no continuous background infusion. The maximum daily dose will be limited to 10 mg for participants over 65 years of age and 20 mg for those 65 or younger.
Data Management and Randomization Participant data will be collected and managed using an electronic Case Report Form (CRF) built with Google Forms and stored in a secure cloud database (Google Sheets). All data will be pseudonymized using a unique alphanumeric identifier assigned at the time of enrollment to ensure participant confidentiality.
Randomization will be performed using a dedicated Google Form configured to provide response options in a random order. The investigator will select the first option presented to assign the participant to either the "case" or "control" group19.
Statistical Analysis Plan Descriptive statistics (mean, median, standard deviation, min/max) will be used to summarize the collected data. The primary endpoint (cumulative number of PCA rescue doses at 48 hours) will be analyzed using a Poisson distribution model.
For other outcomes, a Chi-square test will be used for categorical variables (e.g., need for conversion to general anesthesia), while a t-test (or a non-parametric equivalent) will be used for continuous variables (e.g., NRS pain scores in the recovery room). Analysis of covariance and multiple linear regression may also be conducted to evaluate the role of demographic and clinical characteristics on study outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PENG 360° | Experimental | Procedure: Pericapsular Nerve Group Blocks with Local Infiltration AnalgesiaParticipants assigned to this arm will receive a motor-sparing anesthetic technique. This consists of three ultrasound-guided injections performed before surgery: an anterior Pericapsular Nerve Group (PENG) block, a Local Infiltration Analgesia (LIA) of the incision line, and a posterior PENG (PONG) block. |
| Spinal | Active comparator | Procedure: spinal anesthesiaParticipants assigned to this arm will receive standard spinal anesthesia. The procedure will be performed according to the center's standard practice and guidelines, with the choice of local anesthetic and dosage at the discretion of the anesthesiologist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provision of signed and dated informed consent form.
- Scheduled for hip endoprosthesis surgery for femoral fracture with an anterior, lateral or posterolateral approach (any approach).
- Age 18 years or older.
- Willing and able to comply with the study protocol.
Key exclusion criteria (7 listed)
- Failure to provide informed consent.
- Age less than 18 years.
- Known allergy to local anesthetics or other medications used in the protocol.
- Presence of infection at the planned injection site.
- Pre-existing hip prosthesis or prior major surgery on the same hip (e.g., revision surgery).
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 |
|---|---|---|
| Pericapsular Nerve Group Blocks with Local Infiltration AnalgesiaAlso: PENG 360°; A-PENG +PONG +LIAAn ultrasound-guided, motor-sparing regional anesthesia procedure. It involves three distinct injections: 1) An anterior Pericapsular Nerve Group (A-PENG) block targeting the sensory articular branches of the femoral and obturator nerves. 2) A Local Infiltration Analgesia (LIA) of the surgical incision line. 3) A posterior PENG (PONG) block targeting sensory branches from the sciatic plexus. The local anesthetic mixture consists of ropivacaine, mepivacaine with epinephrine, and dexamethasone in specific volumes for each injection site. | Procedure or surgery | PENG 360° |
| spinal anesthesiaAlso: Spinal Block; Subarachnoid BlockStandard neuraxial anesthesia technique involving the injection of a local anesthetic into the subarachnoid space. The procedure is performed according to the institution's standard clinical practice. The choice of the specific local anesthetic agent, dose, and technique will be at the discretion of the attending anesthesiologist, based on the participant's clinical characteristics. | Procedure or surgery | Spinal |
Primary outcome
Number of Postoperative Analgesic Rescue Doses
Time frame: From arrival in the Post-Anesthesia Care Unit (PACU) up to 48 hours after surgery.
The cumulative number of on-demand analgesic doses (2 mg morphine bolus) requested by the participant via an intravenous Patient-Controlled Analgesia (PCA) pump. The total number of requests will be recorded from the pump's memory at 48 hours postoperatively. This is the primary measure for assessing postoperative pain control.
4 secondary outcomes
Immediate Postoperative Limb Mobility
Time frame: Upon arrival in the Post-Anesthesia Care Unit (PACU), approximately 0-1 hours after surgery.
Incidence of Postoperative Nausea and Vomiting (PONV)
Time frame: Within the first 48 hours after surgery.
Postoperative Pain Intensity
Time frame: Upon arrival in the Post-Anesthesia Care Unit (PACU), approximately 0-1 hours after surgery.
Length of Hospital Stay
Time frame: From the date of surgery until date of hospital discharge, assessed up to 30 days.
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 22 Sep 2026.
- Background: PubMed 31124626Del Buono R, Pascarella G, Costa F, Barbara E. Ultrasound-guided local infiltration analgesia for hip surgery: myth or reality? Minerva Anestesiol. 2019 Nov;85(11):1242-1243. doi: 10.23736/S0375-9393.19.13701-7. Epub 2019 May 21. No abstract available.
- Background: 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.
- Background: PubMed 34263587Del Buono R, Pascarella G, Padua E, Costa F, Tognu A, Terranova G, Greco F, Fajardo Perez M, Barbara E. PENG block: from standard to unconventional approaches. Minerva Anestesiol. 2021 Oct;87(10):1157-1158. doi: 10.23736/S0375-9393.21.15847-X. Epub 2021 Jul 14. No abstract available.
- Background: PubMed 34337929Del Buono R, Padua E, Pascarella G, Costa F, Tognu A, Terranova G, Greco F, Fajardo Perez M, Barbara E. Reply to: Tips for pericapsular nerve group (PENG) neurolytic blocks. Minerva Anestesiol. 2021 Oct;87(10):1151-1152. doi: 10.23736/S0375-9393.21.16019-5. Epub 2021 Aug 2. No abstract available.
- Background: PubMed 34527412Del Buono R, Padua E, Pascarella G, Costa F, Tognu A, Terranova G, Greco F, Fajardo Perez M, Barbara E. Pericapsular hip radiofrequency: future approaches to treat hip chronic pain. Minerva Anestesiol. 2021 Dec;87(12):1393-1394. doi: 10.23736/S0375-9393.21.16081-X. Epub 2021 Sep 16. No abstract available.
- Background: PubMed 38980297Del Buono R, Tognu A. Hip replacement using pericapsular nerve blocks in a high-risk patient. Minerva Anestesiol. 2024 Nov;90(11):1052-1054. doi: 10.23736/S0375-9393.24.18242-9. Epub 2024 Jul 9. No abstract available.
- Background: 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.
- Individual participant dataSharing planned: Yes. Plan Description Individual Participant Data (IPD) that will be shared: The full, de-identified participant dataset. The final study protocol. The statistical analysis plan. How to access the data: Data will be available to qualified researchers for non-commercial, academic purposes upon reasonable request. Interested researchers should submit a formal proposal outlining their research goals to the Principal Investigator. Data sharing timeline: Data will be made available after the publication of the primary study results and will remain available for a period of 5 years.
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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.
Romualdo Del Buono, MD principal investigator
Unit of Anesthesia, Intensive Care and Pain Management, ASST Gaetano Pini, Milan, Italy;
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pericapsular Nerve Group Blocks with Local Infiltration Analgesia and spinal anesthesia in people with Hip Fractures and Arthroplasty, Replacement, Hip, run by ASST Gaetano Pini-CTO 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 7 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 22 Sep 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 Romualdo Del Buono, MD (+39 02 5829 6592, romualdo.delbuono@asst-pini-cto.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Postoperative Analgesic Rescue Doses (time frame: From arrival in the Post-Anesthesia Care Unit (PACU) up to 48 hours after surgery.). 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 NCT07239817, which also lists 7 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 22 Sep 2026.