Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07239817

PENG 360°: Motor-Sparing PENG Block and Local Infiltration Analgesia for Hip Endoprosthesis Surgery with Anterior Approach

Led by ASST Gaetano Pini-CTO · Updated on 2025-12-10

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a new local anesthesia technique compared to standard spinal anesthesia for adults undergoing hip endoprosthesis surgery due to femoral fracture. The study aims to find out if the new motor-sparing method controls pain as effectively as spinal anesthesia during the first two days after surgery and whether it helps participants move their leg sooner. This approach targets sensory nerves around the hip to reduce pain while potentially avoiding side effects like nausea and allowing faster recovery. Participants will be randomly assigned to one of two groups. One group will receive the new anesthesia technique involving three ultrasound-guided injections: an anterior Pericapsular Nerve Group (A-PENG) block, local infiltration analgesia (LIA) around the incision, and a posterior PENG (PONG) block. The other group will receive the standard spinal anesthesia before surgery. All participants will receive standardized post-operative pain treatment including intravenous paracetamol, ketorolac, and morphine via patient-controlled analgesia. During the study, researchers will monitor the amount of additional pain medication used within 48 hours after surgery and assess participants' ability to move their hip, knee, and foot soon after the operation. They will also track nausea, pain intensity, and length of hospital stay. Data will be securely collected and analyzed to compare outcomes between groups. Participation involves follow-up visits and assessments up to 48 hours post-surgery, with hospital stay monitored up to 30 days.

CONDITIONS

Brief Title

PENG Block + LIA For Endoprosthesis Surgery With Anterior Approach

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Day of surgery

Participants receive either a motor-sparing anesthetic technique consisting of three ultrasound-guided injections before surgery or standard spinal anesthesia according to the center's standard practice.

1 visit (in-person)

Post-operative Follow-up

Duration - 48 hours

Participants are monitored for pain, limb mobility, nausea, and other outcomes for up to 48 hours after surgery with a standardized pain management protocol.

Continuous monitoring during hospital stay, including assessments upon arrival in the Post-Anesthesia Care Unit and up to 48 hours post-surgery

Post-operative Follow-up

Duration - Up to 30 days

Participants continue to be observed until hospital discharge to assess length of hospital stay and recovery.

Hospital visits as part of routine care until discharge

Trial Site Locations

Total: 1 location

1

Gaetano Pini-CTO

Milan, Italy, 20122

Actively Recruiting

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Research Team

R

Romualdo Del Buono, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial