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Clinical Trials in Poland / NCT07834619
Starting soon Not applicable

The Impact of Regional Motor-sparing Blocks on Early Rehabilitation Following Primary Hip or Knee Arthroplasty

NCT07834619 · tracked via the Priya Life Science Poland tracker
Phase
Not applicable
Started
2026-09-08
Last updated
2026-09-22

Condition(s) studied

Total Hip Arthroplasty (THA) or Total Knee Arthroplasty (TKA)Preoperative Adductor Canal Block (ACB)Preoperative Pericapsular Nerve Group (PENG)

Investigational drug(s) / intervention(s)

PENG Block with RopivacaineSham PENG BlockAdductor Canal Block with RopivacaineSham Adductor Canal BlockSubarachnoid anesthesiaPain RelieverAnti Inflammatory Drugphysical rehabilitation

PENG Block with Ropivacaine: 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.

Sham PENG Block: 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.

Adductor Canal Block with Ropivacaine: 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.

Sham Adductor Canal Block: 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.

Subarachnoid anesthesia: hyperbaric bupivacaine \[8-12.5 mg\] without intrathecal opioid; propofol sedation to a RASS score of 0 to -2.

Pain Reliever: 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.

Anti Inflammatory Drug: Intravenous dexamethasone, up to 10 mg as a single dose during surgery, provided there are no contraindications.

physical rehabilitation: The first attempt at mobilization is scheduled for 4-6 hours after the end of surgery. Antithrombotic exercises, attempts at sitting up and walking.

Study summary

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

Sex
ALL
Min age
65 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria * 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. * Provision of written informed consent. Exclusion Criteria * 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. * Significant preoperative neurological deficit of the operated limb that would preclude reliable assessment of mobility. * Opioid use disorder or chronic opioid use of ≥30 mg oral morphine equivalent per day for more than 3 months. * Participation in another interventional clinical trial that could affect postoperative rehabilitation. * Inability to ensure assessment of the primary endpoint within the required time window.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Poznań University of Physical Education Poznan Poznan

More Poznan University of Physical Education trials in Poland

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07834619 on ClinicalTrials.gov ↗ ← All trials in Poland