An interventional study of Posterior Capsular Local Infiltration Analgesia and Ultrasound-Guided Pericapsular Nerve Group Block in Hip Ostearthritis, sponsored by Poznan University of Medical Sciences. Not yet recruiting at 2 sites in Poland. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Poznan University of Medical Sciences · Not applicable, Interventional, and Treatment
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.
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.
Poznan University of Medical Sciences is the lead sponsor of 151 studies on the registry; 41 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: 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.
Drug: Posterior Capsular Local Infiltration Analgesia · Drug: Ultrasound-Guided Pericapsular Nerve Group Block
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.
Modified Iowa Level of Assistance Scale Score at 24 Hours
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.
Time frame: 24 hours after the end of surgery
Modified Iowa Level of Assistance Scale Score at 48 Hours
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.
Time frame: 48 hours after the end of surgery
Quality of Recovery at 24 Hours
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.
Time frame: 24 hours after the end of surgery
Quality of Recovery at 48 Hours
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.
Time frame: 48 hours after the end of surgery
Pain Intensity at Rest
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.
Time frame: 6 hours after the end of surgery
Pain Intensity at Rest
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.
Time frame: 12 hours after the end of surgery
Pain Intensity at Rest
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.
Time frame: 24 hours after the end of surgery
Pain Intensity at Rest
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.
Time frame: 48 hours after the end of surgery
Pain Intensity During Movement
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.
Time frame: 6 hours after the end of surgery
Pain Intensity During Movement
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.
Time frame: 12 hours after the end of surgery
Pain Intensity During Movement
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.
Time frame: 24 hours after the end of surgery
Pain Intensity During Movement
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.
Time frame: 48 hours after the end of surgery
Cumulative Opioid Consumption During the First 24 Hours
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.
Time frame: From the end of surgery through 24 hours after surgery
Cumulative Opioid Consumption During the First 48 Hours
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.
Time frame: From the end of surgery through 48 hours after surgery.
Quadriceps Muscle Strength
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.
Time frame: 24 hours after the end of surgery
Quadriceps Muscle Strength
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.
Time frame: 48 hours after the end of surgery
Incidence of Postoperative Nausea and Vomiting
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.
Time frame: 48 hours after surgery
Symptomatic Orthostatic Intolerance During Mobilization
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.
Time frame: 48 hours after surgery.
Postoperative Length of Hospital Stay
Elapsed time in hours from the end of surgery to actual hospital discharge.
Time frame: From the end of surgery to hospital discharge.
Incidence of Procedure-Related Adverse Events
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.
Time frame: From administration of the study intervention through postoperative day 30.
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Data and supporting documents will be available beginning 6 months after publication of the primary study results and will remain available for 5 years.
Access criteria: 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.
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Nov 2027, 11 months later.
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