PENG Block + LIA For Endoprosthesis Surgery With Anterior Approach

NCT07239817 | Recruiting

• 1 other identifier: PeBILIA 5680-25.06.2025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hip Fractures; Pain, Postoperative; Local Anesthesia Infiltration; Arthroplasty, Replacement, Hip; Anesthesia and Analgesia; Nerve Block

Keywords

Pericapsular Nerve Group Block; PENG block; Local Infiltration Analgesia; Spinal Anesthesia; Hip Arthroplasty; Postoperative Pain; Femoral Fractures; Ultrasound Guidance; Early Mobilization

Outcome Measures

Primary Outcomes (1)

• 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.

  From arrival in the Post-Anesthesia Care Unit (PACU) up to 48 hours after surgery.

Secondary Outcomes (4)

• Immediate Postoperative Limb Mobility

  Upon arrival in the Post-Anesthesia Care Unit (PACU), approximately 0-1 hours after surgery.

• Incidence of Postoperative Nausea and Vomiting (PONV)

  Within the first 48 hours after surgery.

• Postoperative Pain Intensity

  Upon arrival in the Post-Anesthesia Care Unit (PACU), approximately 0-1 hours after surgery.

• Length of Hospital Stay

  From the date of surgery until date of hospital discharge, assessed up to 30 days.

Study Arms (2)

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.

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

Procedure: spinal anesthesia

Interventions

spinal anesthesia PROCEDURE

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.

Also known as: Spinal Block; Subarachnoid Block

Spinal

Pericapsular Nerve Group Blocks with Local Infiltration Analgesia PROCEDURE

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.

Also known as: PENG 360°; A-PENG +PONG +LIA

PENG 360°

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form.
• Scheduled for hip endoprosthesis surgery for femoral fracture with an anterior approach.
• Age 18 years or older.
• Willing and able to comply with the study protocol.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ASST Gaetano Pini-CTO: lead

Study Sites (1)

Gaetano Pini-CTO

Milan, 20122, Italy

RECRUITING

Related Publications (7)

• 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.

  PMID: 31124626 BACKGROUND

• Del 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.

  PMID: 33432791 BACKGROUND

• Del 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.

  PMID: 34263587 BACKGROUND

• Del 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.

  PMID: 34337929 BACKGROUND

• Del 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.

  PMID: 34527412 BACKGROUND

• Del 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.

  PMID: 38980297 BACKGROUND

• Giron-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.

  PMID: 30063657 BACKGROUND

MeSH Terms

Conditions

Hip Fractures; Pain, Postoperative; Agnosia; Femoral Fractures

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Romualdo Del Buono, MD

  Unit of Anesthesia, Intensive Care and Pain Management, ASST Gaetano Pini, Milan, Italy;

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Romualdo Del Buono, MD

CONTACT

+39 02 5829 6592; romualdo.delbuono@asst-pini-cto.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: November 20, 2025
• Study Start: December 1, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be made available starting 6 months after the publication of the primary manuscript. Data will remain available for a period of 5 years following publication.
• Access Criteria: Access to the de-identified individual participant data and supporting documents will be granted to qualified academic researchers for non-commercial purposes, such as secondary analysis or meta-analysis. Researchers must submit a formal research proposal to the Principal Investigator for review. A signed data sharing agreement will be required before data is transferred.

Locations

IT (1)