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PENG Blok + LIA Pro Endoprotetickou Chirurgii Předním Přístupem (PENG 360°)

19. září 2026 aktualizováno: Romualdo Del Buono, ASST Gaetano Pini-CTO

PENG 360°: PENG Blok + LIA Při Endoprotéze Kyčle S Předním Přístupem.

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.

Přehled studie

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

100

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: PENG 360°

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.

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.

Ostatní jména:
  • PENG 360°; A-PENG +PONG +LIA
Aktivní komparátor: Spinal

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

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.

Ostatní jména:
  • Spinální blokáda; Subarachnoidální blokáda

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Postoperative Analgesic Rescue Doses
Časové okno: 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.

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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Immediate Postoperative Limb Mobility
Časové okno: Upon arrival in the Post-Anesthesia Care Unit (PACU), approximately 0-1 hours after surgery.

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.

Upon arrival in the Post-Anesthesia Care Unit (PACU), approximately 0-1 hours after surgery.
Incidence of Postoperative Nausea and Vomiting (PONV)
Časové okno: Within the first 48 hours after surgery.

The occurrence of any episode of nausea or vomiting as reported by the participant or observed by clinical staff will be recorded.

Within the first 48 hours after surgery.
Postoperative Pain Intensity
Časové okno: Upon arrival in the Post-Anesthesia Care Unit (PACU), approximately 0-1 hours after surgery.

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.

Upon arrival in the Post-Anesthesia Care Unit (PACU), approximately 0-1 hours after surgery.
Length of Hospital Stay
Časové okno: From the date of surgery until date of hospital discharge, assessed up to 30 days.

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.

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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Romualdo Del Buono, MD, Unit of Anesthesia, Intensive Care and Pain Management, ASST Gaetano Pini, Milan, Italy;

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

9. prosince 2025

Primární dokončení (Odhadovaný)

28. února 2027

Dokončení studie (Odhadovaný)

28. února 2027

Termíny zápisu do studia

První předloženo

30. září 2025

První předloženo, které splnilo kritéria kontroly kvality

18. listopadu 2025

První zveřejněno (Aktuální)

20. listopadu 2025

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

22. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

19. září 2026

Naposledy ověřeno

1. září 2026

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

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.

Časový rámec sdílení IPD

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.

Kritéria přístupu pro sdílení IPD

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.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ICF
  • ANALYTIC_CODE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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