Abdominal Ice Application After Cesarean Section (ICE-CS)
Effect of Intermittent Abdominal Ice Application on Postoperative Pain and Opioid Consumption After Elective Cesarean Section: A Randomized Controlled Study
調査の概要
詳細な説明
This prospective randomized controlled study was conducted to evaluate the effects of intermittent abdominal ice application on postoperative pain and opioid consumption after elective cesarean section. Eighty patients undergoing elective cesarean delivery under spinal anesthesia were randomly assigned in a 1:1 ratio to either an ice application group or a control group. Patients in the intervention group received intermittent abdominal ice application over the surgical incision area for 20-minute sessions every 2 hours during the first postoperative 12 hours in addition to standard multimodal analgesia. The control group received standard postoperative multimodal analgesia alone.
Postoperative pain intensity was assessed using the Numeric Rating Scale (NRS) at predefined postoperative time points during the first 24 hours. Secondary outcomes included tramadol consumption, morphine consumption, patient satisfaction, first analgesic request time, total postoperative pain burden assessed using area under the curve (AUC) analysis, and responder analysis. The study was approved by the local ethics committee, and written informed consent was obtained from all participants before enrollment.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Niğde、トルコ（Türkiye）、51200
- Nigde Omer Halisdemir University Training and Research Hospital
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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:
- Women aged 18-45 years American Society of Anesthesiologists (ASA) physical status I-II Singleton term pregnancy Elective cesarean section performed under spinal anesthesia Ability to understand and use the Numeric Rating Scale (NRS) Written informed consent obtained before participation
Exclusion Criteria:
- Emergency cesarean section Chronic pain disorders or chronic opioid use Allergy or contraindication to study medications Infection or skin lesion at the ice application site Psychiatric or neurological disorders affecting pain assessment Conversion to general anesthesia Refusal to participate in the 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：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
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：Ice Group
Participants received intermittent abdominal ice application over the surgical incision area for 20-minute sessions every 2 hours during the first postoperative 12 hours in addition to standard postoperative multimodal analgesia.
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Intermittent abdominal ice application over the surgical incision area for 20-minute sessions every 2 hours during the first postoperative 12 hours.
他の名前：
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アクティブコンパレータ：Control Group
Participants received standard postoperative multimodal analgesia without abdominal ice application.
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Standard postoperative multimodal analgesia without abdominal ice application.
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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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Postoperative Pain Intensity Assessed Using the Numeric Rating Scale (NRS)
時間枠：During the first 24 postoperative hours
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Postoperative pain intensity was evaluated using the Numeric Rating Scale (NRS; 0-10) at predefined postoperative time points during the first 24 postoperative hours.
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During the first 24 postoperative 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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Postoperative Tramadol Consumption
時間枠：24 postoperative hours
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Total postoperative tramadol consumption during the first 24 postoperative hours.
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24 postoperative hours
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Postoperative Morphine Consumption
時間枠：24 postoperative hours
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Total postoperative morphine consumption during the first 24 postoperative hours.
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24 postoperative hours
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Patient Satisfaction Scores
時間枠：24 postoperative hours
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Patient satisfaction with postoperative pain management assessed during the postoperative period.
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24 postoperative hours
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
その他の研究ID番号
- NOHU-CS-ICE-2022
- 2022/33 (レジストリ識別子：Niğde Ömer Halisdemir University Non-Interventional Clinical Research Ethics Committee)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
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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