An interventional study of PENG Block with Ropivacaine and Sham PENG Block in Total Hip Arthroplasty (THA) or Total Knee Arthroplasty (TKA), Preoperative Adductor Canal Block (ACB) and Preoperative Pericapsular Nerve Group (PENG), sponsored by Poznan University of Physical Education. Not yet recruiting at 1 site in Poland. Open to participants aged 65 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Poznan University of Physical Education · Not applicable, Interventional, and Treatment
The purpose of this study is to determine whether a single nerve block given before surgery can help patients regain independence and mobility more quickly after planned hip or knee replacement surgery for osteoarthritis.
Patients undergoing hip replacement will receive a PENG block, while patients undergoing knee replacement will receive an adductor canal block (ACB). Both procedures will be performed using ultrasound guidance. Some patients will receive a control procedure instead of the active nerve block. All participants will receive standard pain treatment and postoperative rehabilitation.
The main aim of the study is to compare patients' functional independence approximately 24 hours after surgery. Other outcomes will include the ability to walk independently, performance during physiotherapy, muscle strength, pain intensity, opioid use, adverse events, and readiness for hospital discharge. Participants will be followed from the preoperative visit until 90 days after surgery.
The results of this study may help determine whether these nerve blocks are a safe and effective way to support early recovery and restoration of mobility after hip or knee replacement surgery.
The planned study will be a prospective, randomized, controlled clinical trial with blinded outcome assessment, designed to evaluate the effect of a single preoperative ultrasound-guided peripheral nerve block on early functional independence in patients undergoing elective primary unilateral total hip arthroplasty (THA) or total knee arthroplasty (TKA) for osteoarthritis.
Adults scheduled for elective primary unilateral THA or TKA who are able to walk at least 10 meters with or without an assistive device before surgery will be eligible for inclusion. Patients will be randomly allocated to either an intervention group or a control group. The intervention will depend on the type of surgery: patients undergoing THA will receive a single preoperative pericapsular nerve group (PENG) block, whereas patients undergoing TKA will receive a single preoperative adductor canal block (ACB). Both procedures will be performed under ultrasound guidance, using a dose of ropivacaine predefined and limited by the study safety protocol.
Patients in the control group will undergo identical preparation and an ultrasound-guided procedure; however, the needle will not be advanced into the target compartment and no study drug will be administered into the target space. This approach is intended to maintain comparable procedural conditions and minimize the potential influence of patient and staff expectations on study outcomes. Both groups will receive standardized multimodal perioperative analgesia. In the TKA population, both groups will additionally receive identical intraoperative local infiltration analgesia (LIA).
Study Objective The primary objective of the study will be to determine whether a single preoperative PENG block in patients undergoing THA and an ACB in patients undergoing TKA improves early postoperative functional independence compared with the control intervention.
The primary endpoint will be the total score on the modified mILOA/mILAS scale, assessed 24 ± 3 hours after completion of surgery. The scale ranges from 0 to 36 points, with lower scores indicating greater functional independence. The assessment will be performed by a physiotherapist who is blinded to the patient's treatment allocation.
Secondary Outcomes
Key secondary outcomes will include:
hierarchical Timed Up and Go (TUG) outcome at 24 hours after surgery; time from completion of surgery to the first independent 10-meter walk; mILOA/mILAS score at 6 and 48 hours; TUG performance at hospital discharge; effectiveness and quality of the scheduled physiotherapy session; postoperative quadriceps muscle strength; pain intensity assessed using the numerical rating scale (NRS), particularly during movement; total postoperative opioid consumption; incidence and nature of adverse events related to the study intervention; time to readiness for hospital discharge. Follow-up Patient follow-up will begin at the preoperative visit and continue until postoperative day 90. The primary assessment of treatment efficacy will be performed at 24 ± 3 hours after completion of surgery. Additional functional assessments will be performed at predefined time points during the first 48 postoperative hours and at hospital discharge. During the 90-day follow-up period, data regarding postoperative recovery and clinically relevant postoperative events will be collected.
Statistical Analysis The primary efficacy analysis will follow the intention-to-treat principle and will include all randomized patients according to their assigned treatment group. The primary endpoint will be analyzed using a linear regression model with robust standard errors. The model will be adjusted for type of surgery (THA/TKA), study center, and baseline TUG performance.
The primary treatment effect measure will be the adjusted mean difference in the mILOA/mILAS score between the intervention and control groups, reported together with a 95% confidence interval. The direction of the effect will be interpreted according to the scale characteristics, whereby a lower mILOA/mILAS score indicates greater functional independence.
Sensitivity analyses will be performed to assess the robustness of the findings to the underlying analytical assumptions. These will include an ordinal regression model and an appropriate stratified test. Detailed procedures for handling missing data and any per-protocol analyses will be prespecified in the statistical analysis plan.
Clinical Relevance The study is designed to determine whether targeted single-shot peripheral nerve blocks administered before surgery can improve early functional recovery after THA and TKA without compromising safety or the patient's ability to participate effectively in postoperative rehabilitation. Particular emphasis will be placed on functional independence rather than pain control alone, as early restoration of mobility is a key component of contemporary postoperative care following joint arthroplasty.
The study design distinguishes the intervention according to the type of surgery: the PENG block will be evaluated in patients undergoing THA, whereas the ACB will be evaluated in patients undergoing TKA. Identical procedural preparation in the control group, blinded outcome assessment, and standardized analgesic management are intended to minimize the risk of systematic bias and improve the reliability of the assessment of the effects of the study interventions on early postoperative functional recovery.
Poznan University of Physical Education is the lead sponsor of 90 studies on the registry; 27 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.
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.
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.
Patients undergoing total hip replacement receive a single pre-operative ultrasound-guided PENG block with ropivacaine.
Procedure: PENG Block with Ropivacaine · Drug: Subarachnoid anesthesia · Drug: Pain Reliever · Drug: Anti Inflammatory Drug · Procedure: physical rehabilitation
Patients undergoing total hip arthroplasty undergo an identical ultrasound-guided sham procedure without injection into the target compartment, followed by standard multimodal analgesia.
Procedure: Sham PENG Block · Drug: Subarachnoid anesthesia · Drug: Pain Reliever · Drug: Anti Inflammatory Drug · Procedure: physical rehabilitation
Patients undergoing total knee arthroplasty receive a single preoperative ultrasound-guided adductor canal block with ropivacaine.
Procedure: Adductor Canal Block with Ropivacaine · Drug: Subarachnoid anesthesia · Drug: Pain Reliever · Drug: Anti Inflammatory Drug · Procedure: physical rehabilitation
Patients undergoing total knee arthroplasty undergo an identical ultrasound-guided sham procedure without injection into the target compartment, followed by standard multimodal analgesia and identical intraoperative LIA.
Procedure: Sham Adductor Canal Block · Drug: Subarachnoid anesthesia · Drug: Pain Reliever · Drug: Anti Inflammatory Drug · Procedure: physical rehabilitation
A single preoperative ultrasound-guided pericapsular nerve group (PENG) block performed in patients undergoing primary unilateral total hip arthroplasty, using ropivacaine at a dose specified by the study safety protocol.
An ultrasound-guided sham procedure performed using identical patient preparation and ultrasound visualization, without needle insertion into the target compartment or administration of study drug into the target space. Participants receive standard multimodal perioperative analgesia.
A single preoperative ultrasound-guided adductor canal block performed in patients undergoing primary unilateral total knee arthroplasty, using ropivacaine at a dose specified by the study safety protocol.
An ultrasound-guided sham procedure performed using identical patient preparation and ultrasound visualization, without needle insertion into the target compartment or administration of study drug into the target space. Participants receive standard multimodal perioperative analgesia and identical intraoperative local infiltration analgesia.
hyperbaric bupivacaine \[8-12.5 mg\] without intrathecal opioid; propofol sedation to a RASS score of 0 to -2.
Paracetamol 1 g every 6 hours (max. 4 g/day; lower dose as indicated) and celecoxib/NSAID in accordance with local practice, provided there are no contraindications.
Intravenous dexamethasone, up to 10 mg as a single dose during surgery, provided there are no contraindications.
The first attempt at mobilization is scheduled for 4-6 hours after the end of surgery. Antithrombotic exercises, attempts at sitting up and walking.
Total mILOA/mILAS score
Total score on the modified mILOA/mILAS functional independence scale, ranging from 0 to 36 points, with lower scores indicating greater functional independence. The assessment will be performed by a physiotherapist blinded to treatment allocation.
Time frame: 6 months
Hierarchical Timed Up and Go (TUG) outcome
Functional mobility assessed using a hierarchical TUG outcome at approximately 24 hours after surgery.
Time frame: 6 months (November 2026 -April 2027)
Time from completion of surgery to the first independent 10-meter walk
Time elapsed from the end of surgery until the participant is able to independently walk 10 meters, with or without an assistive device, according to the predefined study criteria.
Time frame: 6 months (November 2026 -April 2027)
Total mILOA/mILAS score at 6 and 48 hours
Functional independence assessed using the modified mILOA/mILAS scale (0-36 points), with lower scores indicating greater functional independence.
Time frame: 6 months (November 2026 -April 2027)
Quadriceps muscle strength
The strength of the quadriceps muscle following surgery was assessed using a dynamometer
Time frame: 6 months (November 2026 -April 2027)
Numeric Rating Scale (NRS) pain score during movement
Pain intensity during standardized movement assessed using the 0-10 Numeric Rating Scale, with higher scores indicating greater pain.
Time frame: 6 months (November 2026 -April 2027)
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for May 2027, 8 months later.
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Poznan University of Physical Education