地塞米松 vs 右美托咪定用于iPACK + ACB的TKA手术
罗哌卡因联合神经周围地塞米松与神经周围右美托咪定作为辅助剂在iPACK和收肌管阻滞用于全膝关节置换术:一项随机、双盲、对照试验
This randomized, double-blind, controlled trial is designed to compare the analgesic efficacy and safety of perineural dexamethasone versus perineural dexmedetomidine as adjuvants to ropivacaine for ultrasound-guided interspace between the popliteal artery and the capsule of the posterior knee (iPACK) and adductor canal blocks in patients undergoing primary unilateral total knee arthroplasty (TKA). Elderly participants scheduled for elective TKA will be randomized into three parallel groups: ropivacaine alone (control), ropivacaine combined with perineural dexamethasone, or ropivacaine combined with perineural dexmedetomidine.
The primary objective is to determine whether the addition of either adjuvant reduces postoperative opioid consumption compared with ropivacaine alone and to assess potential differences in analgesic efficacy between the two adjuvants. Secondary outcomes include pain intensity at rest and during mobilization, time to first rescue analgesia, quality of early functional recovery, and the incidence of adverse events, including postoperative nausea and vomiting, motor impairment, and hemodynamic instability.
研究概览
地位
条件
详细说明
Total knee arthroplasty (TKA) is associated with substantial postoperative pain, which may delay rehabilitation, prolong hospital stay, and increase opioid consumption. Ultrasound-guided peripheral nerve blocks are an integral component of multimodal analgesia for TKA, particularly the interspace between the popliteal artery and the capsule of the posterior knee (iPACK) block and the adductor canal block (ACB). These techniques provide effective analgesia while preserving quadriceps motor function, thereby facilitating early mobilization. Ropivacaine is the most commonly used local anesthetic for iPACK and ACB; however, its relatively limited duration often necessitates additional analgesic interventions.
Perineural adjuvants have attracted increasing interest as a means to prolong block duration and enhance the quality of peripheral nerve blockade. Dexamethasone and dexmedetomidine are among the most extensively studied adjuvants; however, their relative clinical efficacy and safety when administered perineurally in TKA remain uncertain. Dexamethasone has been shown to prolong block duration and reduce postoperative pain and opioid requirements, likely through anti-inflammatory and glucocorticoid-mediated mechanisms. Dexmedetomidine, an α2-adrenergic agonist, may further enhance analgesia and sensory block duration but has been associated with adverse effects such as sedation and bradycardia in susceptible patients. Comparative evidence between these agents in the specific context of combined iPACK and ACB is limited, and no clear consensus currently exists regarding their optimal use.
This randomized, double-blind, controlled clinical trial is designed to compare the efficacy and safety of perineural dexamethasone versus perineural dexmedetomidine as adjuvants to ropivacaine for ultrasound-guided iPACK and adductor canal blocks in elderly patients undergoing primary unilateral total knee arthroplasty. Eligible participants will be randomized into three parallel groups: ropivacaine alone (control), ropivacaine with perineural dexamethasone, or ropivacaine with perineural dexmedetomidine. All nerve blocks will be performed according to a standardized protocol by experienced anesthesiologists. Surgical, anesthetic, and postoperative analgesic management will be standardized across groups to minimize potential confounding factors. Participants, care providers, investigators, block practitioners, nursing staff, and outcome assessors will remain blinded to treatment allocation.
The primary outcome is cumulative opioid consumption during the first 24 postoperative hours, expressed as intravenous morphine equivalents. Secondary outcomes include pain intensity at rest and during mobilization, time to first rescue analgesia, motor-sparing profile, hemodynamic effects, quality of early recovery, and the incidence of adverse events such as postoperative nausea and vomiting, hypotension, bradycardia, and neurological symptoms. Functional recovery will additionally be evaluated using standardized physiotherapy milestones.
It is hypothesized that both perineural dexamethasone and dexmedetomidine will reduce postoperative opioid consumption compared with ropivacaine alone, and that one adjuvant may demonstrate superior analgesic efficacy or a more favorable safety profile. The findings of this study may provide clinically relevant evidence to guide the selection of perineural adjuvants for iPACK and adductor canal blocks in total knee arthroplasty, with the potential to improve pain control, accelerate rehabilitation, and reduce opioid exposure in an elderly, at-risk population.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Poznan、波兰、62-701
- Poznan University of Medical Sciences
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age ≥ 65 years
- Scheduled for primary unilateral total knee arthroplasty under standardized anesthetic protocol
- ASA physical status I-III
- Ability to understand the study procedures and provide written informed consent
Exclusion Criteria:
- Contraindications to peripheral nerve blocks (infection at injection site, coagulopathy, patient refusal)
- Known allergy or hypersensitivity to amide local anesthetics, dexamethasone or dexmedetomidine
- Chronic opioid therapy or opioid use > 30 mg oral morphine equivalents per day in the last 3 months
- Severe hepatic or renal impairment
- Significant cognitive impairment, inability to cooperate with pain assessment
- Participation in another interventional trial affecting pain or analgesic consumption
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Control
Patients receive ultrasound-guided iPACK block and adductor canal block (ACB) on the operative limb with ropivacaine 0.2% alone, without any perineural adjuvant. |
Ultrasound-guided iPACK block and adductor canal block are performed using ropivacaine 0.2% in a standardized volume per block (20 mL for iPACK and 20 mL for ACB; adjust according to protocol). No adjuvant is added to the local anesthetic solution. |
|
实验性的:Perineural Dexamethasone
Patients receive ultrasound-guided iPACK and ACB with ropivacaine 0.2% combined with perineural dexamethasone. |
Ultrasound-guided iPACK block and adductor canal block are performed using ropivacaine 0.2% in a standardized volume per block (20 mL + 20 mL). Preservative-free dexamethasone is added to the local anesthetic solution at a dose of (2 x 2 mg). |
|
实验性的:Perineural Dexmedetomidine
Patients receive ultrasound-guided iPACK and ACB with ropivacaine 0.2% combined with perineural dexmedetomidine. |
Ultrasound-guided iPACK block and adductor canal block are performed using ropivacaine 0.2% in a standardized volume per block (20 mL + 20 mL). Dexmedetomidine is added to the local anesthetic solution at a dose of 25ug, distributed between both blocks according to the study protocol |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cumulative opioid consumption in the first 24 hours after surgery
大体时间:0-24 hours postoperatively
|
Total dose of rescue opioid analgesics administered within the first 24 hours after surgery, converted to intravenous morphine equivalents (mg). All opioids given in the post-anesthesia care unit and on the ward will be recorded and converted using standard equianalgesic ratios. |
0-24 hours postoperatively
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pain intensity at rest
大体时间:6 hours postoperatively
|
Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) |
6 hours postoperatively
|
|
Pain intensity at rest
大体时间:12 hours postoperatively
|
Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) |
12 hours postoperatively
|
|
Pain intensity at rest
大体时间:24 hours postoperatively
|
Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) |
24 hours postoperatively
|
|
Pain intensity at rest
大体时间:48 hours postoperatively
|
Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) |
48 hours postoperatively
|
|
Pain intensity during mobilization
大体时间:24 hours postoperatively
|
Pain during active knee flexion and mobilization (e.g., physiotherapy session) assessed using NRS (0-10) |
24 hours postoperatively
|
|
Pain intensity during mobilization
大体时间:48 hours postoperatively
|
Pain during active knee flexion and mobilization (e.g., physiotherapy session) assessed using NRS (0-10) |
48 hours postoperatively
|
|
Time to first rescue analgesia
大体时间:0-48 hours postoperatively
|
Time from completion of the iPACK and ACB blocks to the administration of the first dose of rescue opioid analgesic (in minutes). |
0-48 hours postoperatively
|
|
Incidence of postoperative nausea and vomiting (PONV)
大体时间:0-48 hours postoperatively
|
Number of patients with at least one episode of nausea and/or vomiting requiring antiemetic treatment during the first 24 and 48 hours after surgery. |
0-48 hours postoperatively
|
|
Motor function of the operated limb
大体时间:6 hours postoperatively
|
Quadriceps muscle strength (knee extension and hip adduction) assessed using the Medical Research Council (MRC) scale, ranging from 0 (no muscular contraction) to 5 (normal strength), to evaluate the motor-sparing profile of each analgesic regimen. |
6 hours postoperatively
|
|
Motor function of the operated limb
大体时间:12 hours postoperatively
|
Quadriceps muscle strength (knee extension and hip adduction) assessed using the Medical Research Council (MRC) scale, ranging from 0 (no muscular contraction) to 5 (normal strength), to evaluate the motor-sparing profile of each analgesic regimen. |
12 hours postoperatively
|
|
Motor function of the operated limb
大体时间:24 hours postoperatively
|
Quadriceps muscle strength (knee extension and hip adduction) assessed using the Medical Research Council (MRC) scale, ranging from 0 (no muscular contraction) to 5 (normal strength), to evaluate the motor-sparing profile of each analgesic regimen. |
24 hours postoperatively
|
|
Block-related and systemic adverse events
大体时间:Intraoperative and up to 48 hours postoperatively
|
Incidence of bradycardia, hypotension, oversedation, local anesthetic systemic toxicity (LAST), neurological deficits, signs of infection at the injection site, or any serious adverse events possibly related to the study drugs or blocks. |
Intraoperative and up to 48 hours postoperatively
|
合作者和调查者
调查人员
- 学习椅:Malgorzata Reysner, MD PhD、Poznan University of Medical Sciences
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 13/2025
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
Individual participant data (IPD) that underlie the results reported in the published article will be made available after de-identification. Data will include demographic characteristics, perioperative variables, intervention details, and primary and secondary outcomes.
IPD 共享时间框架
The data will be available beginning 6 months after publication of the main results and for a period of at least 5 years.
IPD 共享访问标准
Data will be shared with qualified researchers for legitimate scientific purposes upon reasonable request. Access requires submission of a methodologically sound proposal, approval by the study investigators, and a data use agreement.
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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