The Impact of Regional Motor-sparing Blocks on Early Rehabilitation Following Primary Hip or Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Total mILOA/mILAS score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The study will be a prospective, single-centre, randomised, controlled superiority trial with two parallel groups, a 1:1 allocation ratio, and blinding of the patient, the assessing physiotherapist and the data analysis team
入排标准
- 年龄范围
- 65 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
THA - PENG Block
Patients undergoing total hip replacement receive a single pre-operative ultrasound-guided PENG block with ropivacaine.
干预措施: Anti Inflammatory Drug (Drug)
THA - PENG Block
Patients undergoing total hip replacement receive a single pre-operative ultrasound-guided PENG block with ropivacaine.
干预措施: physical rehabilitation (Procedure)
THA - Control
Patients undergoing total hip arthroplasty undergo an identical ultrasound-guided sham procedure without injection into the target compartment, followed by standard multimodal analgesia.
干预措施: Sham PENG Block (Procedure)
THA - Control
Patients undergoing total hip arthroplasty undergo an identical ultrasound-guided sham procedure without injection into the target compartment, followed by standard multimodal analgesia.
干预措施: Subarachnoid anesthesia (Drug)
TKA - Control
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.
干预措施: Sham Adductor Canal Block (Procedure)
TKA - Control
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.
干预措施: Subarachnoid anesthesia (Drug)
THA - PENG Block
Patients undergoing total hip replacement receive a single pre-operative ultrasound-guided PENG block with ropivacaine.
干预措施: PENG Block with Ropivacaine (Procedure)
THA - PENG Block
Patients undergoing total hip replacement receive a single pre-operative ultrasound-guided PENG block with ropivacaine.
干预措施: Subarachnoid anesthesia (Drug)
THA - PENG Block
Patients undergoing total hip replacement receive a single pre-operative ultrasound-guided PENG block with ropivacaine.
干预措施: Pain Reliever (Drug)
THA - Control
Patients undergoing total hip arthroplasty undergo an identical ultrasound-guided sham procedure without injection into the target compartment, followed by standard multimodal analgesia.
干预措施: Pain Reliever (Drug)
THA - Control
Patients undergoing total hip arthroplasty undergo an identical ultrasound-guided sham procedure without injection into the target compartment, followed by standard multimodal analgesia.
干预措施: Anti Inflammatory Drug (Drug)
THA - Control
Patients undergoing total hip arthroplasty undergo an identical ultrasound-guided sham procedure without injection into the target compartment, followed by standard multimodal analgesia.
干预措施: physical rehabilitation (Procedure)
TKA - Adductor Canal Block
Patients undergoing total knee arthroplasty receive a single preoperative ultrasound-guided adductor canal block with ropivacaine.
干预措施: Adductor Canal Block with Ropivacaine (Procedure)
TKA - Adductor Canal Block
Patients undergoing total knee arthroplasty receive a single preoperative ultrasound-guided adductor canal block with ropivacaine.
干预措施: Subarachnoid anesthesia (Drug)
TKA - Adductor Canal Block
Patients undergoing total knee arthroplasty receive a single preoperative ultrasound-guided adductor canal block with ropivacaine.
干预措施: Pain Reliever (Drug)
TKA - Adductor Canal Block
Patients undergoing total knee arthroplasty receive a single preoperative ultrasound-guided adductor canal block with ropivacaine.
干预措施: Anti Inflammatory Drug (Drug)
TKA - Adductor Canal Block
Patients undergoing total knee arthroplasty receive a single preoperative ultrasound-guided adductor canal block with ropivacaine.
干预措施: physical rehabilitation (Procedure)
TKA - Control
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.
干预措施: Pain Reliever (Drug)
TKA - Control
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.
干预措施: Anti Inflammatory Drug (Drug)
TKA - Control
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.
干预措施: physical rehabilitation (Procedure)
结局指标
主要结局
Total mILOA/mILAS score
时间窗: 6 months
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.
次要结局
- Hierarchical Timed Up and Go (TUG) outcome(6 months (November 2026 -April 2027))
- Time from completion of surgery to the first independent 10-meter walk(6 months (November 2026 -April 2027))
- Total mILOA/mILAS score at 6 and 48 hours(6 months (November 2026 -April 2027))
- Quadriceps muscle strength(6 months (November 2026 -April 2027))
- Numeric Rating Scale (NRS) pain score during movement(6 months (November 2026 -April 2027))