Effect of Liposomal Bupivacaine and Bupivacaine Hydrochloride for Superior Trunk Block of the Interscalene Brachial Plexus on Postoperative Diaphragmatic Function and Analgesia
2026年5月23日 更新者：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.
調査の概要
状態
招待による登録
研究の種類
介入
入学 (推定)
184
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Jiangsu
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Nanjing、Jiangsu、中国、210006
- Nanjing First Hospital
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Nanjing、Jiangsu、中国
- Nanjing Gaochun People's Hospital
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Suzhou、Jiangsu、中国
- the First Affiliated Hospital of Soochow University
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Liposomal Bupivacaine
When performing a superior trunk block of the interscalene brachial plexus, the local anesthetic used is 1.33% liposomal bupivacaine.
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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.
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アクティブコンパレータ：Bupivacaine Hydrochloride
When performing the superior trunk block of the interscalene brachial plexus, 0.375% bupivacaine hydrochloride is used as the local anesthetic.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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The incidence of hemi-diaphragmatic paralysis( Partial plus complete diaphragmatic paralysis) after superior trunk block of the interscalene brachial plexus
時間枠：Before block 、before leaving the PACU after surgery and 24 hours after surgery
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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.
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Before block 、before leaving the PACU after surgery and 24 hours after surgery
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Numeric Rating Scale (NRS) scores during activity and at rest
時間枠：Postoperative 30 minutes, 1 hour, 6 hours, 12 hours, 24 hours, 36 hours, 48 hours, 60 hours, and 72 hours
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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)
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Postoperative 30 minutes, 1 hour, 6 hours, 12 hours, 24 hours, 36 hours, 48 hours, 60 hours, and 72 hours
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The area under the pain intensity-time curve (PI-AUC)
時間枠：Postoperative periods (0-24 hours, 24-48 hours, 48-72 hours)
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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.
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Postoperative periods (0-24 hours, 24-48 hours, 48-72 hours)
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Postoperative recovery quality (QoR-15 score)
時間枠：Postoperative days 1, 2, and 3
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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.
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Postoperative days 1, 2, and 3
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Analgesia satisfaction (OBAS score)
時間枠：Postoperative days 1, 2, and 3
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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.
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Postoperative days 1, 2, and 3
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Morphine equivalent consumption
時間枠：Postoperative periods of 0-24 hours, 24-48 hours, and 48-72 hours
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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.
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Postoperative periods of 0-24 hours, 24-48 hours, and 48-72 hours
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The cumulative dosage of rescue analgesic medication (calculated as morphine equivalent in mg)
時間枠：0-24 hours, 24-48 hours, and 48-72 hours after the first postoperative administration.
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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.
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0-24 hours, 24-48 hours, and 48-72 hours after the first postoperative administration.
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Telephone follow-up for pain NRS score
時間枠：Postoperative 3 months
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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.
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Postoperative 3 months
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Incidence of adverse events: Vascular injury, hoarseness, Horner's syndrome, SpO2 below 90% without oxygen supplementation after leaving PACU, dyspnea, numbness of fingers, dyskinesia.
時間枠：Postoperative 72 hours
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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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Amaral S, Arsky Lombardi R, Medeiros H, Nogueira A, Gadsden J. Superior Trunk Block Is an Effective Phrenic-Sparing Alternative to Interscalene Block for Shoulder Arthroscopy: A Systematic Review and Meta-Analysis. Cureus. 2023 Nov 3;15(11):e48217. doi: 10.7759/cureus.48217. eCollection 2023 Nov.
- Urmey WF, McDonald M. Hemidiaphragmatic paresis during interscalene brachial plexus block: effects on pulmonary function and chest wall mechanics. Anesth Analg. 1992 Mar;74(3):352-7. doi: 10.1213/00000539-199203000-00006.
- Wilson TA, Legrand A, Gevenois PA, De Troyer A. Respiratory effects of the external and internal intercostal muscles in humans. J Physiol. 2001 Jan 15;530(Pt 2):319-30. doi: 10.1111/j.1469-7793.2001.0319l.x.
- Hutchins JL, Habeck J, Novaczyk Z, Campbell R, Creedon C, Spartz E, Richter M, Wolter J, Suryawanshi G, Kaizer A, Berg AA. Patient Complications after Interscalene Block: A Retrospective Comparison of Liposomal Bupivacaine to Nonliposomal Bupivacaine. Anesthesiol Res Pract. 2020 Mar 27;2020:6704303. doi: 10.1155/2020/6704303. eCollection 2020.
- Ilfeld BM, Sessler DI. Liposomal Bupivacaine in Peripheral Nerve Blocks: Duration and Meaningful Differences. Anesthesiology. 2024 Oct 1;141(4):638-642. doi: 10.1097/ALN.0000000000005133. No abstract available.
- Chan TCW, Wong JSH, Wang F, Fang CX, Yung CS, Chan MTH, Chan WSH, Wong SSC. Addition of Liposomal Bupivacaine to Standard Bupivacaine versus Standard Bupivacaine Alone in the Supraclavicular Brachial Plexus Block: A Randomized Controlled Trial. Anesthesiology. 2024 Oct 1;141(4):732-744. doi: 10.1097/ALN.0000000000005035.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年5月6日
一次修了 (推定)
2027年3月31日
研究の完了 (推定)
2027年12月31日
試験登録日
最初に提出
2026年5月5日
QC基準を満たした最初の提出物
2026年5月12日
最初の投稿 (実際)
2026年5月14日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月28日
QC基準を満たした最後の更新が送信されました
2026年5月23日
最終確認日
2026年5月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Liposomal bupivacaineの臨床試験
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Tanta University完了デクスメデトミジン | 腹腔鏡下胆嚢摘出術 | 方形腰ブロック | 術後鎮痛 | ブピバカイン | 超音波ガイドエジプト
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Kulsoom International Hospital募集
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Allama Iqbal Teaching Hospital完了
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Tanta University完了
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Kocaeli Derince Education and Research Hospital完了