Functional Recovery After PENG Block Plus Periarticular Injection Versus Periarticular Injection Alone in Total Hip Arthroplasty
Pain after hip replacement can make it difficult for older adults to get out of bed, stand up, and walk. This study will investigate whether adding a nerve block to pain-relieving injections given during surgery helps patients regain independence sooner.
The study will include adults aged 65 years or older undergoing planned first-time hip replacement for osteoarthritis. Participants will be assigned by chance to one of two groups. Both groups will receive an injection of a local anaesthetic, ropivacaine, into tissues around the back of the hip joint during surgery. One group will also receive an ultrasound-guided pericapsular nerve group (PENG) block, which involves injecting ropivacaine near nerves that carry pain signals from the hip. Both groups will receive the same usual pain treatment and rehabilitation programme.
The main assessment will take place 24 hours after surgery. A physiotherapist who does not know the participant's treatment group will assess how much help they need to get into and out of bed, stand up, walk, and use stairs.
The study will also assess pain, use of opioid pain medicines, muscle strength, quality of recovery, and side effects. The findings will help determine whether adding a PENG block provides a meaningful benefit for recovery after hip replacement.
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Szczegółowy opis
This study addresses whether the analgesic effects of adding a pericapsular nerve group (PENG) block to posterior capsular local infiltration translate into better early functional recovery after total hip arthroplasty. Reduced pain or opioid consumption alone may not reflect a patient's ability to move independently, particularly when muscle weakness, dizziness, or sedation may also limit rehabilitation.
The primary assessment will therefore focus on the assistance required to perform everyday mobility tasks at a fixed postoperative time. This approach is intended to reduce the influence of staffing schedules and differences in the timing of the first mobilization attempt. Physiotherapists will receive standardized training in administering and scoring the functional assessment. Equivalent rehabilitation opportunities will be provided to both groups, including at weekends.
For each incomplete assessment, the reason will be documented to distinguish clinical inability to perform a task from an assessment missed for organizational reasons. Walking aids, assistance provided, and factors limiting performance will also be recorded.
The trial evaluates the additional value of a standard PENG block within an otherwise standardized care pathway. As the combined strategy includes a higher total dose of ropivacaine, any observed benefit will be interpreted as an effect of the overall strategy rather than proof of an effect attributable solely to the injection location.
Functional outcomes will be interpreted alongside analgesic requirements, muscle strength, patient-reported recovery, and adverse events to assess whether the additional procedure provides a meaningful overall benefit.
Typ studiów
Typ studiów
Zapisy (Szacowany)
Zapisy
Faza
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Poznan, Polska, 62-701
- Poznan University of Medical Sciences
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Kontakt:
- Malgorzata Reysner, M.D. Ph.D.
- Numer telefonu: +48 61 873 83 03
- E-mail: mreysner@ump.edu.pl
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Poznań
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Skórzewo, Poznań, Polska, 61-701
- Poznan University of Medical Sciences
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Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Age 65 years or older.
- Scheduled for elective primary unilateral total hip arthroplasty for osteoarthritis through a posterior surgical approach.
- Planned spinal anaesthesia and eligibility to receive either study analgesic strategy.
- Ability to perform basic transfers and walk independently before surgery, with a walking aid permitted.
- Ability to understand study instructions, report pain using the Numerical Rating Scale, and complete the study questionnaires.
- Written informed consent provided before enrollment.
Exclusion Criteria:
- Hip arthroplasty for an acute fracture, revision arthroplasty, or planned bilateral hip arthroplasty.
- Pre-existing requirement for physical assistance from another person during basic transfers or walking.
- Planned postoperative restrictions that prevent weight-bearing or participation in the study's functional assessments.
- Neurological, neuromuscular, or other musculoskeletal disease that substantially limits mobility independently of the hip condition being treated.
- Cognitive impairment or a communication disorder that prevents informed consent or reliable completion of study assessments.
- Known hypersensitivity to ropivacaine or another medication required for the study interventions.
- Contraindication to spinal anaesthesia, PENG block, or posterior capsular infiltration, including local infection or a bleeding risk that cannot be managed in accordance with applicable regional anaesthesia guidelines.
- A medical condition that makes the planned study interventions or early mobilization unsafe.
- Planned use of an additional regional analgesic technique outside the study protocol.
- Participation in another interventional study that could interfere with the assessment of pain or functional recovery.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
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Aktywny komparator: Posterior Capsular Local Infiltration Analgesia Alone
Participants will receive intraoperative local infiltration of the posterior hip capsule with 20 mL of 0.2% ropivacaine (40 mg), administered by the surgeon. Participants will also receive standardized spinal anaesthesia, postoperative multimodal analgesia, rescue analgesia, and rehabilitation according to the study protocol. |
Intraoperative infiltration of the posterior hip capsule with 20 mL of 0.2% ropivacaine (40 mg), administered by the surgeon during primary total hip arthroplasty. The infiltration technique and timing will be standardized according to the study protocol. |
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Eksperymentalny: PENG Block Plus Posterior Capsular Local Infiltration Analgesia
Participants will receive an ultrasound-guided pericapsular nerve group (PENG) block with 20 mL of 0.2% ropivacaine (40 mg), together with intraoperative local infiltration of the posterior hip capsule with 20 mL of 0.2% ropivacaine (40 mg), administered by the surgeon. The total ropivacaine dose will be 80 mg. Participants will receive the same standardized spinal anaesthesia, postoperative multimodal analgesia, rescue analgesia, and rehabilitation as the comparator group. |
Intraoperative infiltration of the posterior hip capsule with 20 mL of 0.2% ropivacaine (40 mg), administered by the surgeon during primary total hip arthroplasty. The infiltration technique and timing will be standardized according to the study protocol. Ultrasound-guided single-injection pericapsular nerve group (PENG) block using 20 mL of 0.2% ropivacaine (40 mg). The block will be performed by an anaesthesiologist using a standardized technique according to the study protocol, in addition to posterior capsular local infiltration analgesia. |
Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Modified Iowa Level of Assistance Scale Score at 24 Hours
Ramy czasowe: 24 hours after the end of surgery
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Functional recovery will be assessed using the five-item modified Iowa Level of Assistance Scale (mILAS). The scale evaluates the assistance required for supine-to-sitting transfer, sitting-to-supine transfer, sit-to-stand transfer, walking, and stair climbing. Each item is scored from 0 to 6, yielding a total score from 0 to 30. Lower scores indicate less assistance required and greater functional independence. A trained physiotherapist blinded to treatment allocation will administer the assessment according to a standardized scoring manual. The primary outcome is the total mILAS score at 24 hours after surgery. |
24 hours after the end of surgery
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Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Modified Iowa Level of Assistance Scale Score at 48 Hours
Ramy czasowe: 48 hours after the end of surgery
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Functional recovery will be assessed using the five-item modified Iowa Level of Assistance Scale (mILAS). The scale evaluates the assistance required for supine-to-sitting transfer, sitting-to-supine transfer, sit-to-stand transfer, walking, and stair climbing. Each item is scored from 0 to 6, yielding a total score from 0 to 30. Lower scores indicate less assistance required and greater functional independence. A trained physiotherapist blinded to treatment allocation will administer the assessment according to a standardized scoring manual. The primary outcome is the total mILAS score at 48 hours after surgery. |
48 hours after the end of surgery
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Quality of Recovery at 24 Hours
Ramy czasowe: 24 hours after the end of surgery
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Patient-reported recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire. Total scores range from 0 to 150, with higher scores indicating better quality of recovery. |
24 hours after the end of surgery
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Quality of Recovery at 48 Hours
Ramy czasowe: 48 hours after the end of surgery
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Patient-reported recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire. Total scores range from 0 to 150, with higher scores indicating better quality of recovery. |
48 hours after the end of surgery
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Pain Intensity at Rest
Ramy czasowe: 6 hours after the end of surgery
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Pain intensity at rest assessed using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Scores at each assessment time will be analyzed separately. |
6 hours after the end of surgery
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Pain Intensity at Rest
Ramy czasowe: 12 hours after the end of surgery
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Pain intensity at rest assessed using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Scores at each assessment time will be analyzed separately. |
12 hours after the end of surgery
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Pain Intensity at Rest
Ramy czasowe: 24 hours after the end of surgery
|
Pain intensity at rest assessed using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Scores at each assessment time will be analyzed separately. |
24 hours after the end of surgery
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Pain Intensity at Rest
Ramy czasowe: 48 hours after the end of surgery
|
Pain intensity at rest assessed using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Scores at each assessment time will be analyzed separately. |
48 hours after the end of surgery
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Pain Intensity During Movement
Ramy czasowe: 6 hours after the end of surgery
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Pain intensity during a standardized sit-to-stand task will be assessed using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will be asked to rate the highest pain experienced while rising from a chair. Chair height, permitted use of armrests or walking aids, and assistance provided will be standardized according to the study protocol. Inability to attempt the task and the reason will be documented rather than assigned a pain score. Scores at each assessment time will be analyzed separately. |
6 hours after the end of surgery
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Pain Intensity During Movement
Ramy czasowe: 12 hours after the end of surgery
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Pain intensity during a standardized sit-to-stand task will be assessed using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will be asked to rate the highest pain experienced while rising from a chair. Chair height, permitted use of armrests or walking aids, and assistance provided will be standardized according to the study protocol. Inability to attempt the task and the reason will be documented rather than assigned a pain score. Scores at each assessment time will be analyzed separately. |
12 hours after the end of surgery
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Pain Intensity During Movement
Ramy czasowe: 24 hours after the end of surgery
|
Pain intensity during a standardized sit-to-stand task will be assessed using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will be asked to rate the highest pain experienced while rising from a chair. Chair height, permitted use of armrests or walking aids, and assistance provided will be standardized according to the study protocol. Inability to attempt the task and the reason will be documented rather than assigned a pain score. Scores at each assessment time will be analyzed separately. |
24 hours after the end of surgery
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Pain Intensity During Movement
Ramy czasowe: 48 hours after the end of surgery
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Pain intensity during a standardized sit-to-stand task will be assessed using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will be asked to rate the highest pain experienced while rising from a chair. Chair height, permitted use of armrests or walking aids, and assistance provided will be standardized according to the study protocol. Inability to attempt the task and the reason will be documented rather than assigned a pain score. Scores at each assessment time will be analyzed separately. |
48 hours after the end of surgery
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Cumulative Opioid Consumption During the First 24 Hours
Ramy czasowe: From the end of surgery through 24 hours after surgery
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Cumulative dose of all opioid analgesics administered during the first 24 postoperative hours, converted to oral morphine milligram equivalents using conversion factors prespecified in the study protocol. Participants receiving no opioids will be assigned a value of zero. |
From the end of surgery through 24 hours after surgery
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Cumulative Opioid Consumption During the First 48 Hours
Ramy czasowe: From the end of surgery through 48 hours after surgery.
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Cumulative dose of all opioid analgesics administered during the first 48 postoperative hours, converted to oral morphine milligram equivalents using conversion factors prespecified in the study protocol. Participants receiving no opioids will be assigned a value of zero. |
From the end of surgery through 48 hours after surgery.
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Quadriceps Muscle Strength
Ramy czasowe: 24 hours after the end of surgery
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Quadriceps muscle strength of the operated limb will be assessed using the Medical Research Council (MRC) scale, ranging from 0 (no visible or palpable muscle contraction) to 5 (normal muscle strength). A trained physiotherapist blinded to treatment allocation will assess knee extension using standardized patient positioning and testing procedures. Higher scores indicate greater muscle strength. Scores at each assessment time will be analyzed separately. |
24 hours after the end of surgery
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Quadriceps Muscle Strength
Ramy czasowe: 48 hours after the end of surgery
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Quadriceps muscle strength of the operated limb will be assessed using the Medical Research Council (MRC) scale, ranging from 0 (no visible or palpable muscle contraction) to 5 (normal muscle strength). A trained physiotherapist blinded to treatment allocation will assess knee extension using standardized patient positioning and testing procedures. Higher scores indicate greater muscle strength. Scores at each assessment time will be analyzed separately. |
48 hours after the end of surgery
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Incidence of Postoperative Nausea and Vomiting
Ramy czasowe: 48 hours after surgery
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Proportion of participants experiencing at least one episode of nausea or vomiting during the first 48 postoperative hours, regardless of whether antiemetic treatment is administered. |
48 hours after surgery
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Symptomatic Orthostatic Intolerance During Mobilization
Ramy czasowe: 48 hours after surgery.
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Proportion of participants experiencing dizziness, lightheadedness, blurred vision, presyncope, or syncope during postoperative sitting, standing, or walking that requires the mobilization attempt to be interrupted or terminated. |
48 hours after surgery.
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Postoperative Length of Hospital Stay
Ramy czasowe: From the end of surgery to hospital discharge.
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Elapsed time in hours from the end of surgery to actual hospital discharge. |
From the end of surgery to hospital discharge.
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Incidence of Procedure-Related Adverse Events
Ramy czasowe: From administration of the study intervention through postoperative day 30.
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Proportion of participants experiencing at least one adverse event considered potentially related to the PENG block or posterior capsular infiltration, including local anaesthetic systemic toxicity, injection-site infection or hematoma, or new motor or sensory neurological deficit. Event type, onset, severity, duration, and assessed relationship to the intervention will be recorded. |
From administration of the study intervention through postoperative day 30.
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Współpracownicy i badacze
Sponsor
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Rozpoczęcie studiów
Zakończenie podstawowe (Szacowany)
Zakończenie podstawowe
Ukończenie studiów (Szacowany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- 22/2026
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
De-identified individual participant data underlying the published study results will be available upon reasonable request. Shared data will include participant characteristics, allocated interventions, primary and secondary outcome data, and adverse events necessary to reproduce the reported analyses, together with a data dictionary. Direct identifiers will be removed, and potentially identifying variables will be modified or withheld to reduce the risk of re-identification. Data sharing will comply with participant consent, institutional requirements, and applicable data protection requirements.
Ramy czasowe udostępniania IPD
Data and supporting documents will be available beginning 6 months after publication of the primary study results and will remain available for 5 years.
Kryteria dostępu do udostępniania IPD
Researchers submitting a methodologically sound proposal may request access from the principal investigator using the contact details listed in this record. Requests must describe the research question, requested data, and planned analyses. Access will require approval by the responsible institution and, where applicable, the ethics committee, and a signed data use agreement prohibiting re-identification and unauthorized onward sharing. Approved researchers will receive the minimum dataset necessary for the agreed analyses through a secure transfer method.
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ANALITYCZNY_KOD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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