The Effect of Bupivacaine Liposomes on Postoperative Pain in Lung Transplant Patients After Intercostal Nerve Block: a Randomized Controlled Study
The goal of this clinical trial is to evaluate the efficacy and safety of liposomal bupivacaine for postoperative analgesia in adult patients undergoing lung transplantation. The main questions it aims to answer are:
Does liposomal bupivacaine reduce postoperative opioid consumption after lung transplantation? Does liposomal bupivacaine relieve postoperative pain without increasing adverse events?
Researchers will compare patients receiving liposomal bupivacaine combined with bupivacaine hydrochloride with patients receiving bupivacaine hydrochloride alone to see whether liposomal bupivacaine provides better postoperative analgesia and reduces opioid requirements after lung transplantation.
Participants will:
Receive lung transplantation under standard perioperative care. Receive intercostal nerve block with either liposomal bupivacaine combined with bupivacaine hydrochloride or bupivacaine hydrochloride alone.
Be assessed for postoperative opioid consumption, pain scores, recovery-related outcomes, and adverse events after surgery.
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前：Min Yan
- 電話番号：13757118632
- メール：zryanmin@zju.edu.cn
研究場所
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Zhejiang
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Hangzhou、Zhejiang、中国、310000
- The Second Affiliated Hospital of Zhejiang University anesthesiology department
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コンタクト：
- Min Yan
- 電話番号：13757118632
- メール：zryanmin@zju.edu.cn
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Patients with end-stage lung disease undergoing bilateral lung transplantation; Age >18 years; Expected discontinuation of mechanical ventilation within 48 hours after surgery; The patient or legally authorized representative signs the informed consent form and agrees to participate in the study and follow-up.
Exclusion Criteria:
- Body mass index ≤18 kg/m² or ≥35 kg/m²; Allergy or contraindication to local anesthetics; Preoperative tracheal intubation or requirement for extracorporeal life support; Expected use of other types of nerve block; Active systemic infection or infection at the planned block site; Severe hepatic insufficiency; Severe renal impairment; Chronic pain, neuropathic pain, long-term use of analgesics, or use of other psychotropic medications; Preoperative cognitive impairment, cerebrovascular disease, or history of psychiatric disorders; Severe coagulation dysfunction; Concomitant surgery during the same operative session; Pregnant or breastfeeding women.
研究計画
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 |
|---|---|
|
実験的：liposomal bupivacaine group
Patients will receive an intercostal nerve block with a mixture of liposomal bupivacaine and bupivacaine hydrochloride after surgery.
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Patients will receive an intercostal nerve block with a mixture of liposomal bupivacaine and bupivacaine hydrochloride immediately after lung transplantation.
|
|
アクティブコンパレータ：control group
Patients will receive an intercostal nerve block with bupivacaine hydrochloride after surgery.
|
Patients will receive an intercostal nerve block with bupivacaine hydrochloride immediately after lung transplantation.
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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 |
時間枠 |
|---|---|
|
Opioid consumption within 72 hours after surgery
時間枠：72 hours after surgery
|
72 hours after surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
ICU滞在期間
時間枠：90日以内
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90日以内
|
|
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VAS pain scores
時間枠：at 24 hours, 48 hours, 72 hours, and 1 week after surgery;
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ranging from 0 to 100 mm, with 0 indicating no pain and 100 indicating the worst imaginable pain.
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at 24 hours, 48 hours, 72 hours, and 1 week after surgery;
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Area under the curve of VAS pain scores
時間枠：within 72 hours and 1 week after surgery
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within 72 hours and 1 week after surgery
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Quality of recovery
時間枠：within 1 week after surgery
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assessed using the QoR-15 scale
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within 1 week after surgery
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Sleep quality within 1 week after surgery
時間枠：within 1 week after surgery
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assessed using the Insomnia Severity Index (ISI)
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within 1 week after surgery
|
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Anxiety and depression
時間枠：within 1 week after surgery
|
Anxiety and depression symptoms were assessed using the Hamilton Anxiety Rating Scale and Hamilton Depression Rating Scale (HAMA/HAMD), respectively, with HAMA ranging from 0 to 56 and HAMD ranging from 0 to 52.
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within 1 week after surgery
|
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total hospital stay
時間枠：within 90 days
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within 90 days
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Incidence of chronic pain
時間枠：at 3 months after surgery
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Chronic pain was defined as the incidence of pain 3 months post-surgery, assessed using the VAS score.
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at 3 months after surgery
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sleep quality
時間枠：at 3 months after surgery
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Sleep quality was assessed using the Insomnia Severity Index.
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at 3 months after surgery
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anxiety and depression
時間枠：at 3 months after surgery
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assessed using the Hamilton Anxiety Rating Scale and Hamilton Depression Rating Scale (HAMA/HAMD);
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at 3 months after surgery
|
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quality of recovery
時間枠：at 3 months after surgery
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ssessed using the QoR-15 scale
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at 3 months after surgery
|
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Incidence of adverse events
時間枠：within 90 days
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including nausea, vomiting, dizziness, infection, pneumothorax, and other complications.
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within 90 days
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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