Pre-incisional Infiltration With Ropivacaine Plus Triamcinolone for Relieving Postoperative Pain After Thoracoscopic Surgery
The Efficacy and Safety of Pre-incisional Infiltration With Ropivacaine Plus Triamcinolone in Patients Undergoing Video-assisted Thoracoscopic: a Multi-center Randomized Controlled Trial.
Video-assisted thoracoscopic surgery (VATS) is less invasive compared to traditional thoracotomy, but it is still reported that the incidence of acute pain following VATS exceeds 80%. Inadequate postoperative analgesia may trigger a series of adverse physiological stress responses, increase the occurrence of postoperative complications, and affect the rehabilitation process. If acute pain is not managed promptly and sufficiently, nearly one-quarter of patients may develop chronic pain, impacting normal life and sleep quality after discharge. Acute pain after VATS is mainly caused by the release of inflammatory mediators after soft tissue injury at the surgical site, which activates peripheral pain receptors and leads to abnormal action potentials transmitted along A δ and C fibers. Inflammatory mediators released from the soft tissues around incisions not only significantly alters the chemical microenvironment at the peripheral terminals of nociceptors, directly inducing pain, but also sensitizes afferent fibers, contributing to peripheral sensitization. Incisional infiltration is the simplest, safest, and most effective anesthesia method for preventing incision pain after laparoscopic surgery but even using long-acting local anesthetics, the effectiveness of postoperative analgesia can only last for a relatively short period of time. To improve the efficiency of local incision infiltration in postoperative analgesia, at least two issues need to be addressed: prolonging the duration of analgesia and reducing inflammation of nerve surrounding tissues.
Numerous studies have shown that glucocorticoids not only can achieve anti-inflammatory and analgesic effects by inhibiting inflammatory cytokines and inflammatory responses but also can prolong the duration of action of local anesthetics. The investigators conducted a multicenter, prospective, randomized controlled clinical study to explore whether preemptive incisional infiltration with ropivacaine plus triamcinolone is superior to ropivacaine alone in relieving postoperative pain for adults undergoing VATS. The investigators also compare the effects of the two intervention measures on postoperative pain management, patient safety, and recovery quality.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Fang Luo
- 電話番号：+86 13611326978
- メール：13611326978@163.com
研究場所
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Beijing Municipality
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Beijing、Beijing Municipality、中国、100070
- 募集
- Beijing Tiantan Hospital
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コンタクト：
- Fang Luo
- 電話番号：+86 13611326978
- メール：13611326978@163.com
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Patients scheduled for elective thoracoscopic wedge resection, segmentectomy, and lobectomy under general anesthesia;
- Ages 18 to 64 years old
- American Society of Anesthesiologists (ASA) physical status of I-III
- Patients must be able to understand nature and potential personal consequences of the clinical trial and cooperation with follow-up investigations
- signing of the informed consent form.
Exclusion Criteria:
- History of allergies to experimental drugs such as opioids or steroids;
- Alcohol abuse; Long term use of opioid drugs (exceeding 2 weeks or 3 days per week for more than 1 month); Suspected use of sedatives and analgesics; Use analgesic drugs within 24 hours before surgery; Patients undergoing steroid therapy;
- Serious neurological disorders, severe liver and kidney dysfunction, heart failure, etc;
- Unable to use pain assessment scale;
- Pregnant or lactating patients.
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：4倍
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：Pre-incisional infiltration with 0.5%ropivacaine and triamcinolone 80mg
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Before the surgery, according to the surgeon's incision marking, the patients accept 2ml of triamcinolone (80mg) plus 15ml of 1% ropivacaine diluted with 0.9% saline to a total volume of 30ml infiltrates the incision layer by layer (1ml subcutaneous infiltration at each location, 2ml full layer infiltration, total 3ml).
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アクティブコンパレータ：Pre-incisional infiltration with 0.5% ropivacaine alone
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Before the surgery, according to the surgeon's incision marking, the patients accept 30ml of 0.5% ropivacaine infiltrates the incision layer by layer (1ml subcutaneous infiltration at each location, 2ml full layer infiltration, total 3ml).
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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 |
|---|---|
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Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively
時間枠：The postoperative period 48 hours
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The postoperative period 48 hours
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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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術後1週間、1ヶ月、3ヶ月における安静時数字評価尺度（NRSr）
時間枠：術後7日目、1ヶ月目、3ヶ月目。
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数値評価尺度（NRS）では、0は痛みなし、10は最も激しい痛みを表します。スコア1～3は軽度の痛み、4～6は中等度の痛み、7～10は重度の痛みを示します。
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術後7日目、1ヶ月目、3ヶ月目。
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Adverse events
時間枠：Within 72 hours postoperatively
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Including local anesthetic poisoning, local hematoma, nausea and vomiting, itching, hypotension, arrhythmia, delirium, etc; Abnormal values in clinical laboratory tests, such as elevated blood glucose levels.
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Within 72 hours postoperatively
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Area under the curve (AUC) of the Numerical Rating Scale during movement (NRSm) within 0-72 hours postoperatively
時間枠：Data will be collected at 4、12、24、36 and 72 hours postoperatively
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The Numeric Rating Scale (NRS) designates 0 as representing no pain and 10 as representing the most severe pain, scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain.
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Data will be collected at 4、12、24、36 and 72 hours postoperatively
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Area Under the Curve (AUC) of Numeric Rating Scale at rest (NRSr) Within 0-72 Hours Postoperatively
時間枠：Time Frame: Data will be collected at 4、12、24、36 and 72 hours postoperatively
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scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain
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Time Frame: Data will be collected at 4、12、24、36 and 72 hours postoperatively
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Patient Satisfaction Scale(PSS)
時間枠：Postoperative hours 4、12、24 and 48 hours
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Patient Satisfaction Scale(PSS) on a scale ranging from 0 to 10, where 0 denotes "completely dissatisfied" and 10 signifies "extremely satisfied".
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Postoperative hours 4、12、24 and 48 hours
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Postoperative nausea and vomiting (PONV)
時間枠：Postoperatively within 48 hours.
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The PONV score is expressed on a scale of 0-3: 0 indicates no nausea, 1 indicates mild nausea that does not require treatment, 2 indicates nausea that requires treatment, and 3 indicates vomiting.
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Postoperatively within 48 hours.
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wound healing score at 72 h, 1 and 3 months postoperatively and patient and observer scar assessment scale (POSAS) at 72 h, 1 and 3 months.
時間枠：Postoperative 72 hours、1 and 3 months.
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The wound healing score includes three aspects: skin healing, incision infection, and hair growth.The total score is obtained by adding up the three scores: excellent wound healing: 3; good wound: 4-5; poor wound healing: greater than or equal to 6 points. POSAS: the observer scores the scar based on the distribution of vessels, color, scar thickness, surface roughness, area, and softness around the incision, with each score ranging from 1 to 10. One indicates that the scar features are close to normal skin, and the higher the score, the more severe the scar (OSAS score); the patient evaluates the scar based on whether there is pain or itching, color, softness, thickness, and self perception. Each score range is also 1-10, with 1 indicating no difference from normal skin and a higher score indicating more severe scars. The higher the score between the two, the more severe the scar. |
Postoperative 72 hours、1 and 3 months.
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研究の完了 (推定)
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