About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Scheduled for elective primary unilateral total hip arthroplasty (THA) or total knee arthroplasty (TKA) due to osteoarthritis.
Planned spinal anesthesia according to the study protocol.
Ability to walk at least 10 meters before surgery, with or without an assistive device.
Ability to understand and follow the instructions for the mILOA/mILAS and Timed Up and Go (TUG) assessments.
Disqualifiers
Revision arthroplasty, simultaneous bilateral arthroplasty, or arthroplasty performed due to fracture, tumor, or infection.
Contraindication to the study nerve block, ropivacaine, spinal anesthesia, or any mandatory component of the analgesic regimen.
Coagulopathy or anticoagulant therapy incompatible with current recommendations for peripheral nerve blocks or neuraxial anesthesia.
Infection at the planned needle insertion site.
Trial design
Parallel
Treatments tested in this trial
PENG Block with Ropivacaine
Procedure/SurgeryA 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.
Sham PENG Block
Procedure/SurgeryAn 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.
Adductor Canal Block with Ropivacaine
Procedure/SurgeryA 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.
Sham Adductor Canal Block
Procedure/SurgeryAn 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.
Subarachnoid anesthesia
Drughyperbaric bupivacaine \[8-12.5 mg\] without intrathecal opioid; propofol sedation to a RASS score of 0 to -2.
Pain Reliever
DrugParacetamol 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.
Anti Inflammatory Drug
DrugIntravenous dexamethasone, up to 10 mg as a single dose during surgery, provided there are no contraindications.
physical rehabilitation
Procedure/SurgeryThe first attempt at mobilization is scheduled for 4-6 hours after the end of surgery. Antithrombotic exercises, attempts at sitting up and walking.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Hierarchical Timed Up and Go (TUG) outcome
Functional mobility assessed using a hierarchical TUG outcome at approximately 24 hours after surgery.
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.
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.
Quadriceps muscle strength
The strength of the quadriceps muscle following surgery was assessed using a dynamometer
Sponsors and contacts
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