A Clinical Study on Vagus Nerve Blockade at the Gastroesophageal Junction Combined With Tegileridine in the Very Early Postoperative Recovery Following Bariatric Surgery
This study aims to investigate, through a prospective randomized controlled clinical trial, the clinical value of vagal nerve block at the gastroesophageal junction combined with tizanidine in the very early postoperative recovery following bariatric surgery. Patients who have undergone bariatric surgery often experience visceral pain due to the inflammatory response triggered by partial gastrectomy. Conventional analgesic regimens have limited efficacy in controlling this type of visceral pain, whereas vagus nerve block at the gastroesophageal junction can directly block the transmission of pain signals from this region, thereby specifically alleviating visceral pain; the combined use of tegileridine could reduce postoperative opioid dosage and lower the risk of related adverse reactions. By comparing these two different analgesic regimens, this study examines their effects on patients' postoperative pain intensity, early mobilization, and adverse reactions such as respiratory depression, nausea, vomiting, and constipation. This study aims to clarify the efficacy and safety of this combined regimen in precisely relieving visceral pain, optimizing perioperative analgesia, reducing opioid-related complications, alleviating gastrointestinal adverse reactions, promoting early ambulation, and accelerating recovery, thereby providing clinical evidence for the establishment of a more comprehensive and individualized multimodal analgesia and Enhanced Recovery After Surgery (ERAS) system for bariatric surgery.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Aged 18 to 70 years, regardless of gender;
- BMI meets the clinical criteria for bariatric surgery;
- ASA physical status classification I-II;
- Scheduled to undergo laparoscopic sleeve gastrectomy or gastric bypass surgery;
- Fully understands the details of this study, voluntarily agrees to participate, and has signed a written informed consent form
Exclusion Criteria:
- Contraindications for regional nerve block procedures (e.g., coagulation disorders, infection at the puncture site, etc.);
- Allergy to local anesthetics, tizanidine, or opioids;
- Severe cardiac, pulmonary, hepatic, or renal dysfunction;
- History of chronic pain or long-term use of opioid analgesics prior to surgery;
- Pregnant or breastfeeding women;
- Mental illness or cognitive impairment that prevents the participant from cooperating with pain scoring and other assessments;
- Other circumstances deemed by the investigator to make the participant unsuitable for participation in this study;
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 |
|---|---|
|
アクティブコンパレータ：The control group
Bilateral transverse abdominal plane block and intravenous administration of Tegileridine |
Bilateral Transversus Abdominis Plane Block (TAPB): Ultrasound-guided TAPB, 20 mL of 0.25% ropivacaine on each side. Intravenous infusion of 1 mg of Tegileridine. |
|
実験的：The experimental group
Bilateral transverse abdominal plane block and intravenous administration of Tegileridine combined with the vagus nerve block at the gastroesophageal junction |
Bilateral Transversus Abdominis Plane Block (TAPB): Ultrasound-guided TAPB, 20 mL of 0.25% ropivacaine on each side. Intravenous infusion of 1 mg of Tegileridine. Vagus nerve block at the gastroesophageal junction: Under direct laparoscopic visualization, locate the vagus nerve trunks on both sides of the gastroesophageal junction and inject 3 mL of 0.33% ropivacaine into each side. |
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 |
|---|---|---|
|
Visual analogue scale (VAS) Score
時間枠：postoperative 0, 2, 6, 12, and 24 hours
|
The VAS score refers to drawing a 10-cm scale on a piece of paper. One end of the scale is marked as 0, indicating no pain; the other end is marked as 10, indicating severe pain; the values in between represent different degrees of pain. |
postoperative 0, 2, 6, 12, and 24 hours
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Quality-of-Recovery 15 (QoR-15) Score
時間枠：postoperative 1 day
|
The QoR-15 includes 5 items related to physical comfort, 4 items regarding emotional state, 2 items concerning self-care ability, 2 items related to psychological support, and 2 items about pain. There are a total of 15 subjective parameters. Each item is scored on a scale of 0 to 10. The total score of QoR-15 ranges from 0 to 150. The higher the score, the better the condition. |
postoperative 1 day
|
|
Incidence of postoperative respiratory depression
時間枠：postoperative 1, 2, 3 days
|
Postoperative respiratory depression is defined as a sustained (>1 minute) decrease in oxygen saturation to <90%, or a respiratory rate of <8 breaths per minute, or a decrease in oxygen saturation to <94% accompanied by a respiratory rate of <10 breaths per minute, requiring supplemental oxygen to maintain oxygen saturation (SpO₂) >94%, and in the absence of obvious upper airway obstruction. |
postoperative 1, 2, 3 days
|
|
Rescue analgesia rate
時間枠：postoperative 1, 2, 3 days
|
postoperative 1, 2, 3 days
|
|
|
Total dose of sufentanil for rescue analgesia
時間枠：postoperative 1, 2, 3 days
|
postoperative 1, 2, 3 days
|
|
|
Time of first ambulation
時間枠：postoperative 1, 2, 3 days
|
postoperative 1, 2, 3 days
|
|
|
Total Hospital Stay
時間枠：postoperative 7 days
|
postoperative 7 days
|
|
|
Adverse effects
時間枠：postoperative 1, 2, 3 days
|
postoperative 1, 2, 3 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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- FirstAHXiamenU-YB-5
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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