Effect of Optimal Biological Volume Bupivacaine Liposome Interscalene Brachial Plexus Block on Postoperative Analgesia After Shoulder Arthroscopy
2026年8月27日 更新者：Qing-he Zhou、Affiliated Hospital of Jiaxing University
This study aims to evaluate whether 15ml/75mg low-dose bupivacaine liposome is non-inferior to 15ml/133mg standard-dose bupivacaine liposome for postoperative analgesia in interscalene brachial plexus block during arthroscopic shoulder surgery, through a single-center, prospective, double-blind, non-inferiority randomized controlled clinical trial.
It will also assess whether 15ml/75mg low-dose bupivacaine liposome is superior to 15ml/133mg standard-dose bupivacaine liposome in terms of diaphragmatic excursion, pulmonary function, duration of block effect, and nerve block-related adverse reactions during interscalene brachial plexus block.
調査の概要
状態
招待による登録
詳細な説明
This study is designed as a single-center, prospective, double-blind, non-inferiority randomized controlled clinical trial, to evaluate and compare whether the postoperative analgesic efficacy of 15 mL/75 mg low-dose liposomal bupivacaine for interscalene brachial plexus block in patients undergoing shoulder arthroscopy is non-inferior to that of 15 mL/133 mg standard-dose liposomal bupivacaine, and to further assess whether the low-dose regimen demonstrates advantages over the standard-dose counterpart in terms of diaphragmatic excursion, pulmonary function, duration of block effect, and nerve block-related adverse reactions.
研究の種類
介入
入学 (推定)
40
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
-
-
Zhejiang
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Jiaxing、Zhejiang、中国、314000
- Jiaxing University Affiliated Hospital
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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 aged 18 years or older.
- ASA classification I-III.
- Arthroscopic shoulder rotator cuff repair, capsular plication, acromioplasty, synovectomy, etc.
Exclusion Criteria:
- Have a history of lung disease.
- Coagulation dysfunction or coagulopathy.
- History of allergy to local anesthetics.
- infection or lesions at the block site; or history of cervical spine disease.
- pregnancy.
- Refusal to participate in the study or inability to communicate.
- Long-term use of opioids.
- Body mass index >35 kg/m2
- Previous history of nerve injury, paralysis, or paresis;
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：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：OBV bupivacaine liposome group
Following our preliminary study protocol, 13 mL of liposomal bupivacaine (derived from the 20 mL/266 mg commercial formulation) is aspirated and further diluted with 0.9% sodium chloride injection to a final total volume of 53 mL while maintaining the fixed total dose of 266 mg.
This diluted preparation is then combined with 2 mL of 0.5% conventional bupivacaine, and the resultant 55 mL mixture is administered to perform interscalene brachial plexus block prior to surgical incision.
|
Following our preliminary study protocol, 13 mL of liposomal bupivacaine (derived from the 20 mL/266 mg commercial formulation) is aspirated and further diluted with 0.9% sodium chloride injection to a final total volume of 53 mL while maintaining the fixed total dose of 266 mg.
This diluted preparation is then combined with 2 mL of 0.5% conventional bupivacaine, and the resultant 55 mL mixture is administered to perform interscalene brachial plexus block prior to surgical incision.
|
|
実験的：Standard dose bupivacaine liposome group
Following the recommendations in published literature and the approved product labeling, 10 mL of liposomal bupivacaine (20 mL/266 mg formulation) is aspirated, combined with 2 mL of 0.5% conventional bupivacaine, diluted to a final total volume of 15 mL with 0.9% sodium chloride injection, and administered to perform ultrasound-guided interscalene brachial plexus block prior to surgical incision.
|
Following the recommendations in published literature and the approved product labeling, 10 mL of liposomal bupivacaine (20 mL/266 mg formulation) is aspirated, combined with 2 mL of 0.5% conventional bupivacaine, diluted to a final total volume of 15 mL with 0.9% sodium chloride injection, and administered to perform ultrasound-guided interscalene
|
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 |
|---|---|---|
|
Difference in numeric rating scale scores for resting pain at 24 hours after surgery
時間枠：postoperative 24 hours
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Difference in numeric rating scale scores(0 = no pain, 10 = worst pain; higher numbers indicate greater pain intensity) for resting pain at 24 hours after surgery.
Postoperatively, the NRS scale was used to evaluate pain scores.
|
postoperative 24 hours
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Total consumption of morphine milligram equivalents within 72 hours postoperatively
時間枠：within 72 hours postoperatively
|
Record opioid analgesics within 72 hours postoperatively, convert to morphine equivalent dose, and calculate the total amount.
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within 72 hours postoperatively
|
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Differences in numeric rating scale pain scores at rest and during activity within 0.5 hours, 6 hours, 24 hours, 48 hours, and 72 hours postoperatively
時間枠：postoperative 0.5 hours, 6 hours, 24 hours, 48 hours, 72 hours
|
Differences in numeric rating scale (0 = no pain, 10 = worst pain; higher numbers indicate greater pain intensity) pain scores at rest and during activity within 0.5 hours, 6 hours, 24 hours, 48 hours, and 72 hours postoperatively.
Postoperatively, the NRS scoring scale was used to assess pain scores.
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postoperative 0.5 hours, 6 hours, 24 hours, 48 hours, 72 hours
|
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Complete unilateral HDP during quiet breathing at 0.5 hours 6 hours, and 24 hours after completion of block
時間枠：postoperative 0.5 hours, 6 hours and 24 hours
|
A diaphragm excursion of >75% on the blocked side measured under ultrasound is defined as complete unilateral hemidiaphragmatic paralysis (HDP).
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postoperative 0.5 hours, 6 hours and 24 hours
|
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Pulmonary function
時間枠：postoperative 0.5 hours, 6 hours and 24 hours
|
Use a portable respiratory function tester for bedside testing; have the patient blow three times and take the average.
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postoperative 0.5 hours, 6 hours and 24 hours
|
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All adverse events related to surgery and anesthesia occurring within 72 hours postoperatively
時間枠：within 72 hours postoperatively
|
Adverse events associated with nerve blocks within 72 hours postoperatively, including pneumothorax, intravascular injection, local anesthetic toxicity, and Horner syndrome, were recorded.
|
within 72 hours postoperatively
|
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The number of rescue analgesic interventions required within 72 hours postoperatively
時間枠：within 72 hours postoperatively
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The number of analgesic administrations within the first 72 hours postoperatively was recorded.
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within 72 hours postoperatively
|
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sensorimotor score
時間枠：postoperative 0.5 hours, 6 hours and 24 hours
|
After completion of the block, the simplified sensorimotor assessment scale (3-point method) is used for evaluation, and a total sensorimotor score ≥12 points with a total sensory score ≥3 points is defined as successful brachial plexus block.
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postoperative 0.5 hours, 6 hours and 24 hours
|
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。
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9月1日
一次修了 (推定)
2028年9月1日
研究の完了 (推定)
2028年9月1日
試験登録日
最初に提出
2026年8月23日
QC基準を満たした最初の提出物
2026年8月27日
最初の投稿 (実際)
2026年8月28日
学習記録の更新
投稿された最後の更新 (実際)
2026年8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8月27日
最終確認日
2026年8月1日
詳しくは
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