Pre-incisional Infiltration With Ropivacaine Plus Diprospan for Relieving Postoperative Pain After Laparoscopic Surgery
The Efficacy and Safety of Pre-incisional Infiltration With Ropivacaine Plus Diprospan in Patients Undergoing Laparoscopic Surgery: a Multi-center Randomized Controlled Trial.
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. Studies have shown that up to 80% of patients experience postoperative pain following laparoscopic surgery due to inflammation caused by surgical incisions and surrounding tissues, necessitating pharmacological relief. Inflammatory mediators released from the soft tissues around laparoscopic 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.
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. Preemptive incisional infiltration using local anesthetics with corticosteroids which have potent local anti-inflammatory properties may play a key role in preventing or reducing postoperative pain. The objective of this trial is to determine whether preemptive incisional infiltration with ropivacaine plus diprospan is superior to ropivacaine alone in relieving postoperative pain for adults undergoing laparoscopic surgery. 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
-
-
Beijing Municipality
-
Beijing、Beijing Municipality、中国、100070
- 募集
- Beijing Tiantan Hospital
-
コンタクト：
- Fang Luo
- 電話番号：+86 13611326978
- メール：13611326978@163.com
-
-
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 Laparoscopic Surgery for laparoscopic cholecystectomy, appendectomy, or hernia repair 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 |
|---|---|
|
アクティブコンパレータ：Pre-incisional infiltration with ropivacaine alone
|
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).
|
|
実験的：Pre-incisional infiltration with ropivacaine plus diprospan
|
Before the surgery, according to the surgeon's incision marking, the patients accept 0.5ml of diprospan (1ml diprospan: Betamethasone Dipropionate 5mg and Betamethasone Sodium Phosphate 2mg) 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).
|
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 |
|---|---|
|
Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively
時間枠：The postoperative period 48 hours
|
The postoperative period 48 hours
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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。
|
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。
|
術後7日目、1ヶ月目、3ヶ月目。
|
|
Adverse events
時間枠：Within 72 hours postoperatively
|
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.
|
Within 72 hours postoperatively
|
|
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
|
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.
|
Data will be collected at 4、12、24、36 and 72 hours postoperatively
|
|
Patient Satisfaction Scale(PSS)
時間枠：Postoperative hours 4、12、24 and 48 hours
|
Patient Satisfaction Scale(PSS) on a scale ranging from 0 to 10, where 0 denotes "completely dissatisfied" and 10 signifies "extremely satisfied".
|
Postoperative hours 4、12、24 and 48 hours
|
|
Postoperative nausea and vomiting (PONV)
時間枠：Postoperatively within 48 hours
|
Measured 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.
|
Postoperatively within 48 hours
|
|
Wound healing score
時間枠：Postoperative 72 hours、1 and 3 months
|
The wound healing score is evaluated by independent researchers based on the wound healing score table, which 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 points; Good wound healing is 4-5; Poor wound healing: total score greater than or equal to 6 points.
|
Postoperative 72 hours、1 and 3 months
|
|
Postoperatively and patient and observer scar assessment scale
時間枠：Postoperative 72 hours、1 and 3 months
|
Postoperatively and patient and observer scar assessment scale: the observer scores the scar based on the distribution of blood vessels around the incision, color, scar thickness, surface roughness, area, and softness.
Each score ranges from 1 to 10 points and higher scores indicating more severe scars; 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 points, with 1 point indicating no difference from normal skin and a higher score indicating more severe scars.
|
Postoperative 72 hours、1 and 3 months
|
|
Area Under the Curve (AUC) of Numeric Rating Scale at rest (NRSr) Within 0-72 Hours Postoperatively
時間枠：Data will be collected at 4、12、24、36 and 72 hours postoperatively
|
Description: scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain
|
Data will be collected at 4、12、24、36 and 72 hours postoperatively
|
協力者と研究者
スポンサー
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
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。