iPACK + ACB를 이용한 TKA에서 덱사메타손 대 덱스메데토미딘
전 슬관절 치환술에서 iPACK 및 내전근관 차단을 위한 로피바카인 보조제로서 신경주위 덱사메타손 대 신경주위 덱스메데토미딘: 무작위, 이중 맹검, 대조 시험
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
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Poznan, 폴란드, 62-701
- Poznan University of Medical Sciences
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
활성 비교기: 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. |
|
실험적: 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). |
|
실험적: 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 |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cumulative opioid consumption in the first 24 hours after surgery
기간: 0-24 hours postoperatively
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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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pain intensity at rest
기간: 6 hours postoperatively
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Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) |
6 hours postoperatively
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Pain intensity at rest
기간: 12 hours postoperatively
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Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) |
12 hours postoperatively
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Pain intensity at rest
기간: 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
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Pain intensity at rest
기간: 48 hours postoperatively
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Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) |
48 hours postoperatively
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Pain intensity during mobilization
기간: 24 hours postoperatively
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Pain during active knee flexion and mobilization (e.g., physiotherapy session) assessed using NRS (0-10) |
24 hours postoperatively
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Pain intensity during mobilization
기간: 48 hours postoperatively
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Pain during active knee flexion and mobilization (e.g., physiotherapy session) assessed using NRS (0-10) |
48 hours postoperatively
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Time to first rescue analgesia
기간: 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
|
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Incidence of postoperative nausea and vomiting (PONV)
기간: 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
기간: 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
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Motor function of the operated limb
기간: 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
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Motor function of the operated limb
기간: 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
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Block-related and systemic adverse events
기간: Intraoperative and up to 48 hours postoperatively
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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
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공동 작업자 및 조사자
수사관
수사관
- 연구 의자: Malgorzata Reysner, MD PhD, Poznan University of Medical Sciences
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 13/2025
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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 공유 기간
The data will be available beginning 6 months after publication of the main results and for a period of at least 5 years.
IPD 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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