Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Laparoscopic Cholecystectomy (REVISED-PVB II)
2026年5月6日 更新者：Xiangcai Ruan, MD, PhD、Sixth Affiliated Hospital, Sun Yat-sen University
Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Laparoscopic Cholecystectomy: A Randomized Clinical Trial
After laparoscopic cholecystectomy, pain remains an important problem affecting patient recovery.
A revised paravertebral block (r-PVB) was developed as a single-shot, large-volume intercostal-space injection performed at the exposed mid-axillary eighth or ninth intercostal level with the patient kept supine after induction of anesthesia.
Rather than puncturing the classical paraspinal target near the transverse process with a specific prone or lateral position of the patient, r-PVB is designed to exploit medial spread of local anesthetic along the intercostal-endothoracic-extrapleural continuum, thereby generating a functional paravertebral block while avoiding direct entry into the paravertebral space and specific body positioning.
r-PVB addresses several practical limitations of conventional PVB by eliminating the need to reposition an anesthetized patient, using a more accessible and potentially clearer sonographic window, reducing interference from transverse-process shadowing, and facilitating in-plane needle visualization.
調査の概要
研究の種類
介入
入学 (推定)
250
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。
研究連絡先
- 名前：Xiangcai Ruan, MD
- 電話番号：+86 13760710099
- メール：ruanxc@mail.sysu.edu.cn
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:
- Age 18 years or older
- Scheduled for elective laparoscopic cholecystectomy for benign gallbladder disease
Exclusion Criteria:
- Contraindications to nerve block, including skin infection at the puncture site, increased intracranial pressure, uncorrectable coagulopathy, bridging indication for therapeutic anticoagulation (CHADS-VASc ≥ 8), sepsis, or allergy to local anesthetics
- Surgeon-estimated high likelihood of conversion to open surgery
- Chronic opioid use
- Heart failure, liver failure, or renal failure
- Coagulation disorders
- History of allergy to local anesthetics
- Inability to comply with the study protocol, including severe psychiatric illness, refusal to provide informed consent, or anticipated difficulty with postoperative follow-up
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：処理
- 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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介入なし：コントロール
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実験的：r-PVB
Participants in this arm will receive Revised-Paravertebral Nerve Block (r-PVB) after induction of general anesthesia and before the start of surgery.
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Revised-Paravertebral Nerve Block (r-PVB) is performed after induction of general anesthesia and before the start of surgery.
Under ultrasound guidance, an intercostal space between the 7th and 9th ribs at the midaxillary line is identified.
Using an in-plane technique, the needle is advanced into the internal intercostal muscle, and 30 mL of 0.5% ropivacaine is injected to achieve the block.
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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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Mean QoR-15 score on postoperative days 1 and 2
時間枠：Postoperative day 1 and postoperative day 2
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Quality of recovery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15), ranging from 0 (the worst) to 150 (the best).
The primary recovery outcome is the mean QoR-15 score measured on postoperative day 1 and postoperative day 2.
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Postoperative day 1 and postoperative day 2
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Mean postoperative NRS pain score during the first 2 postoperative days
時間枠：From discharge from the post-anesthesia care unit through postoperative day 2.
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Postoperative pain will be assessed using theNumeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst pain the patient can imagine).
The primary pain outcome is the mean of eight postoperative NRS pain scores assessed upon discharge from the post-anesthesia care unit; on the evening of surgery between 7:00 PM and 9:00 PM; and on postoperative days 1 and 2, in the morning between 6:00 AM and 10:00 AM, at midday between 12:00 PM and 3:00 PM, and in the evening between 7:00 PM and 9:00 PM.
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From discharge from the post-anesthesia care unit through postoperative day 2.
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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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Postoperative opioid and analgesic consumption
時間枠：Postoperative day 1 and postoperative day 2
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Postoperative opioid and other analgesic consumption will be recorded and compared between groups.
Opioid use will be converted to oral morphine equivalents where appropriate.
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Postoperative day 1 and postoperative day 2
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Postoperative complications
時間枠：From surgery through postoperative day 30
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Postoperative complications, including pneumothorax, nausea, vomiting, dizziness, respiratory depression, and other adverse events, will be recorded and compared between groups.
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From surgery through postoperative day 30
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Length of postoperative hospital stay
時間枠：From surgery through postoperative day 30
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Length of hospital stay will be defined as the total number of days hospitalized after surgery, including readmission within 30 days if applicable.
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From surgery through postoperative day 30
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Proportion of participants with NRS pain score 4 or greater
時間枠：Postoperative day 1 and postoperative day 2
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The proportion of participants with clinically significant pain, defined as an Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst pain the patient can imagine), score of 4 or greater, will be compared between groups.
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Postoperative day 1 and postoperative day 2
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Resting and movement NRS pain scores on postoperative days 1 and 2
時間枠：Postoperative day 1 and postoperative day 2
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Resting and movement-related pain will be assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst pain the patient can imagine), at predefined time points on postoperative days 1 and 2.
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Postoperative day 1 and postoperative day 2
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Patient satisfaction with analgesia
時間枠：Postoperative day 2
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Patient satisfaction with postoperative analgesia will be assessed using a Numeric Rating Scale, ranging from 0 (very dissatisfied) to 10 (very satisfied).
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Postoperative day 2
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence of local anesthetic systemic toxicity
時間枠：From intervention through postoperative day 30
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The incidence of local anesthetic systemic toxicity (LAST) will be recorded and compared between groups.
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From intervention through postoperative day 30
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Morbidity within 30 days after surgery
時間枠：From surgery through postoperative day 30
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Postoperative morbidity within 30 days after surgery will be recorded and compared between groups.
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From surgery through postoperative day 30
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Readmission within 30 days after surgery
時間枠：From surgery through postoperative day 30
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Hospital readmission within 30 days after surgery will be recorded and compared between groups.
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From surgery through postoperative day 30
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QoR-15 score at 30 days after surgery
時間枠：Postoperative day 30
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Quality of recovery at 30 days after surgery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15), ranging from 0 (the worst) to 150 (the best).
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Postoperative day 30
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NRS pain scores at 30 days after surgery
時間枠：Postoperative day 30
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Resting and movement-related pain at 30 days after surgery will be assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst pain the patient can imagine).
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Postoperative day 30
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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。
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4月27日
一次修了 (推定)
2027年3月27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4月18日
QC基準を満たした最初の提出物
2026年4月27日
最初の投稿 (実際)
2026年5月5日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月11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6日
最終確認日
2026年4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。
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