- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07616102
Effect of Bupivacaine Liposome Injection on Muscle Strength After Total Knee Arthroplasty (TKA)
2026년 5월 26일 업데이트: General Hospital of Ningxia Medical University
Effect of Bupivacaine Liposome Adductor Canal Block on Muscle Strength After Total Knee Arthroplasty.
This study employs a randomized controlled trial to investigate whether bupivacaine liposome injection for adductor canal block can effectively improve lower limb muscle strength after total knee arthroplasty.
연구 개요
상태
아직 모집하지 않음
상세 설명
Total knee arthroplasty (TKA) involves significant trauma, and postoperative patients often experience moderate to severe pain, which limits early knee joint functional exercise and affects functional recovery.
Peripheral nerve blocks can effectively relieve pain, but while providing adequate analgesia, they may also affect the motor nerves of the lower limbs, increasing the risk of falls when patients begin ambulation.
Some studies have found that the incidence of falls in patients using nerve blocks during the early postoperative period, especially during hospitalization, can be as high as 2% .
The actual incidence in clinical practice may be even higher.
The period of highest risk is when the nerve block effect has not completely subsided and patients begin attempting to ambulate, typically within 24 to 48 hours after surgery.
The loss of muscle strength caused by motor nerve blockade is the most direct cause of postoperative falls, primarily due to severe weakness in key stabilizing muscle groups such as the quadriceps.The adductor canal block has clear advantages.
However, traditional local anesthetics, represented by ropivacaine or bupivacaine, typically provide effective analgesia for only 12-24 hours after a single injection, making it difficult to fully cover the peak pain period of 48-72 hours postoperatively.
Continuous femoral nerve block with ropivacaine can provide prolonged analgesia.
When combined with a sciatic nerve block, it can achieve nearly complete analgesia coverage for the knee.
Its drawback is its association with quadriceps impairment, which may increase the risk of falls.
Continuous adductor canal block also provides prolonged analgesia and has a lesser impact on postoperative muscle strength, but it faces challenges such as catheter placement difficulty and inconvenience for postoperative mobility.
In contrast, bupivacaine liposome can provide analgesia for up to 72 hours.
If, while offering high-quality analgesia, bupivacaine liposome indeed causes significant weakening of quadriceps strength during the critical first 2-3 days after surgery, the safety and effectiveness of early patient ambulation would be greatly compromised, potentially even increasing the risk of falls.
This would contradict the original intent of using the adductor canal block to preserve muscle strength.
Conversely, if it is proven to have a lesser impact on muscle strength compared to continuous femoral nerve block, it could become an almost ideal analgesic option.
연구 유형
중재적
등록 (추정된)
80
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Xin li Ni, MD
- 전화번호: 13909586966
- 이메일: xinlii6@nyfy.com.cn
연구 연락처 백업
- 이름: Qiaojiang Shen
- 전화번호: 17829917323
- 이메일: 2832394521@qq.com
연구 장소
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Ningxia
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Yinchuan, Ningxia, 중국
- General Hospital of Ningxia Medical University
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연락하다:
- Xinli Ni, MD
- 전화번호: 86-0951-6743252
- 이메일: xinlini6@nyfy.com.cn
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Patients aged 60-75 years scheduled for elective TKA;
- ASA physical status classification II-III;
- BMI 18-30 kg/m²;
- Agreement to participate in this study and provision of signed informed consent.
Exclusion Criteria:
- Individuals with communication barriers such as language or hearing impairments;
- Patients with contraindications to nerve blocks;
- Severe systemic diseases, such as severe renal disease (estimated glomerular filtration rate below 50 mL/min), cardiac disease (congestive heart failure New York Heart Association Class III to IV), or severe hepatic disease defined as a current or past diagnosis of acute/subacute hepatic necrosis, acute liver failure, chronic liver disease, liver abscess, hepatic coma, or hepatorenal syndrome;
- History of long-term opioid use (defined as daily or nearly daily opioid use within the past 3 months).
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: a single-injection adductor canal block
An ultrasound-guided adductor canal block is performed via the conventional adductor canal approach.
Under ultrasound guidance, 20 milliliters of 1.33% bupivacaine liposome is injected into the adductor canal.
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An ultrasound-guided adductor canal block is performed via the conventional adductor canal approach.
Under ultrasound guidance, 20 milliliters of 1.33% bupivacaine liposome is injected into the adductor canal.
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활성 비교기: continuous femoral nerve block
An ultrasound-guided perineural sheath block of the femoral nerve is performed via the conventional femoral nerve approach.
A femoral nerve catheter is then placed and connected to an analgesia pump containing 150 milliliters of 0.20% ropivacaine.
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An ultrasound-guided perineural sheath block of the femoral nerve is performed via the conventional femoral nerve approach.
A femoral nerve catheter is then placed and connected to an analgesia pump containing 150 milliliters of 0.20% ropivacaine.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Quadriceps Muscle Strength
기간: 24 hours after surgery
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The Maximum Voluntary Isometric Contraction (MVIC) test is used to assess quadriceps strength.
The tester holds a handheld dynamometer.
The patient sits on the bed with legs hanging naturally, and the knee is flexed to 60°.
The patient is instructed to slowly exert force to extend the knee forward.
As the patient exerts force, the tester applies an equal and opposite counterforce with the dynamometer to maintain the position and angle of the lower leg.
The patient sustains maximum effort for 3-5 seconds, and the peak value displayed on the dynamometer is recorded as the result for that trial.
Each leg is tested 2-3 times, with a 60-90 second rest between trials to prevent muscle fatigue from affecting the results.
The average value is recorded as the final outcome.
The unit of measurement is Newtons (N).
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24 hours after surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Quadriceps muscle strength at other time points
기간: 48 hours after surgery
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The Maximum Voluntary Isometric Contraction (MVIC) test is used to assess quadriceps strength.
The tester holds a handheld dynamometer.
The patient sits on the bed with legs hanging naturally, and the knee is flexed to 60°.
The patient is instructed to slowly exert force to extend the knee forward.
As the patient exerts force, the tester applies an equal and opposite counterforce with the dynamometer to maintain the position and angle of the lower leg.
The patient sustains maximum effort for 3-5 seconds, and the peak value displayed on the dynamometer is recorded as the result for that trial.
Each leg is tested 2-3 times, with a 60-90 second rest between trials to prevent muscle fatigue from affecting the results.
The average value is recorded as the final outcome.
The unit of measurement is Newtons (N).
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48 hours after surgery
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Numeric Rating Scale (NRS) Score
기간: 24 and 48 hours after surgery
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Using a scale from 0 to 10 to indicate pain intensity, where 0 represents no pain and 10 represents the worst possible pain.
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24 and 48 hours after surgery
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Quadriceps muscle strength grade
기간: 24 and 48 hours after surgery
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Perform a Manual Muscle Test (MMT).
The patient is placed in the supine position, with a soft pillow under the knee to provide slight flexion, or sits on the edge of the bed with legs hanging naturally.
The examiner stabilizes the patient's thigh with one hand to prevent hip compensation and applies downward resistance with the other hand just above the patient's ankle.
Instruct the patient to forcefully extend the knee against the resistance.
Observe muscle contraction and joint range of motion, and assess according to the 0-5 grade muscle strength scale.
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24 and 48 hours after surgery
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Knee Joint Range of Motion
기간: 24 and 48 hours after surgery
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Using a goniometer, accurately measure the patient's knee joint flexion and extension range of motion.
During measurement, the patient is in the supine position.
The axis of the goniometer is aligned with the lateral femoral condyle, the stationary arm is parallel to the long axis of the femur, and the movable arm is parallel to the long axis of the tibia.
Record the angles at full knee extension (0°) and maximum flexion separately.
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24 and 48 hours after surgery
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Total Opioid Consumption
기간: From the end of the surgery until 72 hours postoperatively
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Total postoperative consumption of opioids.
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From the end of the surgery until 72 hours postoperatively
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Postoperative Adverse Reactions
기간: From the end of the surgery until 72 hours postoperatively
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Including nausea and vomiting, urinary retention, constipation, puncture site ecchymosis and infection, as well as local anesthetic systemic toxicity.
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From the end of the surgery until 72 hours postoperatively
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: Xinli Ni, General Hospital of Ningxia Medical University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 6월 10일
기본 완료 (추정된)
2026년 10월 30일
연구 완료 (추정된)
2026년 11월 3일
연구 등록 날짜
최초 제출
2026년 3월 27일
QC 기준을 충족하는 최초 제출
2026년 5월 26일
처음 게시됨 (실제)
2026년 5월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 29일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 26일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
근력에 대한 임상 시험
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Istanbul University모병Masticatory Muscle Pain | 근시 통증 증후군 (MP)칠면조
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Istanbul University모병이갈이 | 근막 통증 증후군 | Masticatory Muscle Pain | 현지 근육통터키 (Türkiye)
a single-injection adductor canal block에 대한 임상 시험
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Wayne State University완전한
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Ain Shams University아직 모집하지 않음기능 회복 | 내전관 블록 | 슬관절 전치환술
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University of Chicago완전한
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Bakirkoy Dr. Sadi Konuk Research and Training Hospital완전한