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Effect of Liposomal Bupivacaine and Bupivacaine Hydrochloride for Superior Trunk Block of the Interscalene Brachial Plexus on Postoperative Diaphragmatic Function and Analgesia

2026년 5월 23일 업데이트: Hongwei Shi, Nanjing First Hospital, Nanjing Medical University

Effect of Liposomal Bupivacaine and Bupivacaine Hydrochloride for Superior Trunk Block of the Interscalene Brachial Plexus on Postoperative Diaphragmatic Function and Analgesia in Shoulder Surgery: A Multicenter, Randomized Controlled Study

To compare the effects of 1.33% liposomal bupivacaine versus 0.375% bupivacaine hydrochloride for superior trunk block of the interscalene brachial plexus on postoperative diaphragmatic function and analgesic efficacy in shoulder surgery.

연구 개요

상태

초대로 등록

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

184

단계

  • 해당 없음

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이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 중국
    • Jiangsu
      • Nanjing, Jiangsu, 중국, 210006
        • Nanjing First Hospital
      • Nanjing, Jiangsu, 중국
        • Nanjing Gaochun People's Hospital
      • Suzhou, Jiangsu, 중국
        • the First Affiliated Hospital of Soochow University

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

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아니

설명

Inclusion Criteria:

  • Patients scheduled for elective unilateral proximal humerus surgery, rotator cuff surgery, shoulder arthroplasty, or shoulder arthroscopy;
  • Visible diaphragmatic movement on the surgical side under ultrasound before anesthesia;
  • Patient provides informed consent;
  • Age 18-80 years, any gender;
  • ASA physical status I-III;
  • 18 kg/m² ≤ BMI ≤ 30 kg/m².

Exclusion Criteria:

  • Coagulopathy;
  • Allergy to local anesthetics;
  • Infection at the puncture site;
  • History of chronic pain or opioid use;
  • Severe respiratory disease;
  • Pregnancy;
  • Diabetes and peripheral neuropathy;
  • Inability to understand assessment scales.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Liposomal Bupivacaine
When performing a superior trunk block of the interscalene brachial plexus, the local anesthetic used is 1.33% liposomal bupivacaine.
의약품: Liposomal bupivacaine
The superior trunk was visualized distal to the convergence of the C5 and C6 nerve roots but proximal to the take-off of the suprascapular nerve. The block needle was advanced in-plane to the ultrasound beam in a lateral-to-medial direction under the deep cervical fascia and superficial to the middle scalene muscle, until the needle tip was immediately adjacent to the lateral border of the superior trunk. 1.33% Liposomal bupivacaine 10ml was injected.
활성 비교기: Bupivacaine Hydrochloride
When performing the superior trunk block of the interscalene brachial plexus, 0.375% bupivacaine hydrochloride is used as the local anesthetic.
의약품: Bupivacaine Hydrochloride
The superior trunk was visualized distal to the convergence of the C5 and C6 nerve roots but proximal to the take-off of the suprascapular nerve. The block needle was advanced in-plane to the ultrasound beam in a lateral-to-medial direction under the deep cervical fascia and superficial to the middle scalene muscle, until the needle tip was immediately adjacent to the lateral border of the superior trunk. 0.375% Bupivacaine Hydrochloride 10ml was injected.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
The incidence of hemi-diaphragmatic paralysis( Partial plus complete diaphragmatic paralysis) after superior trunk block of the interscalene brachial plexus
기간: Before block 、before leaving the PACU after surgery and 24 hours after surgery
Observe diaphragmatic movement through the hepatic or splenic acoustic window and measure the amplitude of diaphragmatic excursion on the anesthetized side using M-mode (average of 3 waveforms). Diaphragmatic Function Evaluation[4,5]: A decrease in diaphragmatic excursion amplitude during deep breathing of <25% compared to pre-block is defined as normal diaphragmatic movement. A decrease of 25%-75% is defined as partial diaphragmatic paralysis. A decrease of >75% is defined as complete diaphragmatic paralysis.
Before block 、before leaving the PACU after surgery and 24 hours after surgery

2차 결과 측정

결과 측정
측정값 설명
기간
Numeric Rating Scale (NRS) scores during activity and at rest
기간: Postoperative 30 minutes, 1 hour, 6 hours, 12 hours, 24 hours, 36 hours, 48 hours, 60 hours, and 72 hours
Pain intensity at the surgical site will be assessed using the 11-point Numeric Rating Scale (NRS), where 0 represents "no pain" and 10 represents "the worst pain imaginable." Patients will self-report their pain intensity at rest (Resting NRS) and during active movement (Dynamic NRS)
Postoperative 30 minutes, 1 hour, 6 hours, 12 hours, 24 hours, 36 hours, 48 hours, 60 hours, and 72 hours
The area under the pain intensity-time curve (PI-AUC)
기간: Postoperative periods (0-24 hours, 24-48 hours, 48-72 hours)
The Pain Intensity-Area Under the Curve (PI-AUC) will be calculated as a summary measure of overall pain burden over time. The AUC for each patient will be computed for three consecutive postoperative periods based on the serial NRS scores (both resting and dynamic) collected during those intervals. A smaller AUC indicates better overall analgesic control during the specified period.
Postoperative periods (0-24 hours, 24-48 hours, 48-72 hours)
Postoperative recovery quality (QoR-15 score)
기간: Postoperative days 1, 2, and 3
Patient-reported recovery quality will be assessed using the 15-item Quality of Recovery (QoR-15) questionnaire. This validated tool evaluates physical comfort, physical independence, psychological support, emotional state, and pain. Scores range from 0 (extremely poor recovery) to 150 (excellent recovery). The upward trend of the QoR-15 score signifies a progressive and comprehensive improvement in a patient's postoperative recovery experience across physical, emotional, and functional domains.
Postoperative days 1, 2, and 3
Analgesia satisfaction (OBAS score)
기간: Postoperative days 1, 2, and 3
Patient satisfaction with analgesia and its associated side effects will be evaluated using the Overall Benefit of Analgesia Score (OBAS). The OBAS is a composite score (range 0-28, lower is better) incorporating assessments of pain intensity, nausea/vomiting, dizziness, sedation, itching, and patient satisfaction. The downward trend of the OBAS score indicates a progressively more favorable balance between analgesic efficacy and the burden of treatment-related side effects, representing an increasing net benefit of the analgesia regimen.
Postoperative days 1, 2, and 3
Morphine equivalent consumption
기간: Postoperative periods of 0-24 hours, 24-48 hours, and 48-72 hours
The total consumption of all opioid analgesics administered to the patient (including patient-controlled analgesia and rescue doses). All opioid doses will be converted to intravenous morphine milligram equivalents (MME) using standard conversion ratios for summation and comparison. A lower morphine equivalent consumption indicates better analgesic efficacy and a longer duration of action for liposomal bupivacaine.
Postoperative periods of 0-24 hours, 24-48 hours, and 48-72 hours
The cumulative dosage of rescue analgesic medication (calculated as morphine equivalent in mg)
기간: 0-24 hours, 24-48 hours, and 48-72 hours after the first postoperative administration.
This refers specifically to the summed dose of supplemental (rescue) opioid analgesics administered upon patient request for breakthrough pain. The cumulative dose for each period will be calculated and expressed in intravenous morphine milligram equivalents (MME). A lower morphine equivalent consumption indicates better analgesic efficacy and a longer duration of action for liposomal bupivacaine.
0-24 hours, 24-48 hours, and 48-72 hours after the first postoperative administration.
Telephone follow-up for pain NRS score
기간: Postoperative 3 months
Patients will be contacted by telephone at 3 months after surgery. They will be asked to self-report their current average pain intensity over the past 24 hours at the surgical site using the 11-point Numeric Rating Scale (NRS, 0-10), where 0 represents "no pain" and 10 represents "the worst pain imaginable." This assesses the potential long-term impact of the analgesic intervention on persistent postoperative pain.
Postoperative 3 months
Incidence of adverse events: Vascular injury, hoarseness, Horner's syndrome, SpO2 below 90% without oxygen supplementation after leaving PACU, dyspnea, numbness of fingers, dyskinesia.
기간: Postoperative 72 hours

Vascular injury: Evidence of hematoma or vascular puncture during needle placement.

Hoarseness: Patient-reported or clinician-identified voice change suggestive of recurrent laryngeal nerve involvement.

Horner's syndrome: Presence of ptosis, miosis, and/or anhidrosis on the blocked side.

Diaphragmatic paralysis: defined by a reduction in diaphragmatic excursion amplitude >25% from baseline on ultrasound assessment performed post-block.

SpO2 <90% on room air after PACU discharge: Oxygen saturation falling below 90% while breathing room air, occurring after the patient has been discharged from the PACU, and not related to other obvious causes.

Dyspnea: Subjective sensation of shortness of breath or labored breathing. Finger numbness: Persistent numbness or loss of sensation in the fingers of the blocked upper limb.

Motor difficulty: Persistent weakness or inability to perform specific voluntary movements in the blocked upper limb.
Postoperative 72 hours

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스폰서

Nanjing First Hospital, Nanjing Medical University

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일반 간행물

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 5월 6일

기본 완료 (추정된)

2027년 3월 31일

연구 완료 (추정된)

2027년 12월 31일

연구 등록 날짜

최초 제출

2026년 5월 5일

QC 기준을 충족하는 최초 제출

2026년 5월 12일

처음 게시됨 (실제)

2026년 5월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 28일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 23일

마지막으로 확인됨

2026년 5월 1일

추가 정보

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추가 관련 MeSH 약관

기타 연구 ID 번호

  • KY20260402-03

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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. .

어깨 관절 성형술에 대한 임상 시험

Liposomal bupivacaine에 대한 임상 시험

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