Comparing Suprascapular Nerve Block and Interscalene Block for Post-thoracotomy Pain in Pediatric Patients.
Targeted Regional Analgesia for Post-Thoracotomy Ipsilateral Shoulder Pain in Pediatrics: Evaluating the Role of Suprascapular Nerve Block Versus Interscalene Block" A Randomized Controlled Study.
The goal of this clinical trial is to determine which regional block provides superior analgesia in pediatric patients undergoing thoracic surgery. The main questions it aims to answer are:
- Does one block technique provide better pain relief?
- Does the choice of block reduce opioid requirements and complication rates? Researchers will compare two block techniques to see if one offers an effective opioid-sparing strategy that improves patient comfort and reduces side effects.
Participants will:
- Receive one of the studied block interventions during thoracic surgery.
- Be monitored for postoperative pain scores, opioid consumption, and any complications.
調査の概要
状態
条件
詳細な説明
This prospective randomized controlled trial aims to evaluate and compare the effectiveness and safety of two regional analgesic techniques-suprascapular nerve block (SSNB) and interscalene brachial plexus block (ISB)-for managing ipsilateral shoulder pain (ISP) following pediatric thoracotomy. ISP is a common and distressing postoperative complication, affecting 30-85% of thoracotomy patients, and is often poorly responsive to systemic opioids and thoracic epidural analgesia due to its referred pain origin via the phrenic and suprascapular nerves.
Identifying effective targeted analgesic strategies is therefore clinically important. The study will be conducted at Children's Cancer Hospital 57357 and will include 126 pediatric patients (5-18 years, ASA II-III) undergoing elective open thoracotomy.
Participants will be randomized into three groups:
- Thoracic epidural analgesia plus interscalene block.
- Thoracic epidural analgesia plus suprascapular nerve block.
- Thoracic epidural analgesia alone (control). Ultrasound-guided regional blocks will be administered using 0.25% bupivacaine (maximum 2 mg/kg) on the operative side. Postoperative pain scores will be assessed using the Numeric Rating Scale at 2, 4, 6, 12, and 24 hours, alongside total opioid consumption and adverse event monitoring.
The primary objective is to compare the analgesic efficacy of SSNB and ISB in reducing ISP after thoracotomy, while secondary outcomes include postoperative opioid requirements and complication rates. This study is significant because it addresses a persistent clinical challenge in pediatric thoracic surgery pain management. By identifying an effective opioid-sparing regional analgesic technique, the findings may improve postoperative comfort, reduce opioid-related side effects, enhance recovery, and inform evidence-based postoperative pain management protocols for pediatric thoracotomy patients.
研究の種類
入学 (推定)
段階
- フェーズ2
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Nancy Ashraf Abdellatif
- 電話番号：+21141083507
- メール：nancy.ashraf@57357.com
研究連絡先のバックアップ
- 名前：Dina Elgalaly
- 電話番号：+0201154021119
- メール：dina.elgalaly@57357.org
研究場所
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Egypt
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Cairo、Egypt、エジプト、11617
- 募集
- Children's Cancer Hospital 57357
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コンタクト：
- Dina elgalaly
- 電話番号：2025351500
- メール：delgalaly@gmail.com
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- ASA physical status II-III
- Elective open thoracotomy
Exclusion Criteria:
- Pre-existing shoulder pathology
- Coagulopathy or infection at injection site
- Allergy to local anesthetics
- Neurological disorders involving upper limb
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：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：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：group A
Thoracic epidural analgesia + Interscalene brachial plexus block; will be done pre-emptive after induction of anesthesia with 0.25% bupivacaine with maximum dose of 2mg/kg.
|
regional anesthesia technique performed at the level of the upper trunks of the brachial plexus to provide pain relief and anesthesia for surgeries involving the shoulder, clavicle, and upper arm.
It is commonly used in orthopedic and thoracic procedures where shoulder pain is significant.
|
|
実験的：group B
Thoracic epidural analgesia + anterior supraclavicular nerve block will be done pre-emptive after induction of anesthesia with 0.25% bupivacaine with maximum dose of 2mg/kg.
|
is a regional anesthesia technique targeting the trunks of the brachial plexus just above the clavicle, providing rapid and dense anesthesia for surgeries of the upper limb below the shoulder.
It is often referred to as the "spinal of the arm" because of its effectiveness in numbing the arm quickly.
|
|
他の：group C
Thoracic epidural analgesia only.
Control group
|
Control- standard treatment.
A regional anesthesia technique in which a local anesthetic (sometimes combined with opioids) is injected into the epidural space of the thoracic spine to block nerve transmission and provide pain relief.
|
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：Multiple intervals (2, 4, 6, 12, and 24 hours)
|
VAS is a tool used to measure the intensity of pain or other subjective experiences. It is a 10-centimeter line, one end represents "no pain" (0), and the other end represents "worst imaginable pain" (10). The patient marks a point on the line that reflects their pain level. The score is then measured in centimeters or millimeters from the "no pain" end, giving a numerical value. Scores are collected at multiple intervals (2, 4, 6, 12, and 24 hours). This approach accounts for the repeated measurements and evaluates the interaction between the intervention groups and time. 0 = No pain 1-3 = Mild pain 4-6 = Moderate pain 7-9 = Severe pain 10 = Worst imaginable pain |
Multiple intervals (2, 4, 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 |
|---|---|---|
|
Total postoperative opioid consumption
時間枠：24 hours postoperative
|
Total postoperative opioid consumption will be compared across the three groups using a One-way ANOVA or the Kruskal-Wallis test, depending on the distribution of the data.
Post-hoc pairwise comparisons will be conducted using Tukey's HSD or Dunn's test with Bonferroni correction to identify specific group differences.
|
24 hours postoperative
|
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Incidence of adverse effects
時間枠：24 hours postoperative
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The incidence of adverse effects will be compared using the Chi-square test, which is a statistical method used to compare the incidence (frequency or proportion) of categorical outcomes across groups.
|
24 hours postoperative
|
協力者と研究者
捜査官
- 主任研究者：Suzan Adlan Khedr、Children's Cancer Hospital 57357
研究記録日
主要日程の研究
研究開始 (実際)
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
その他の研究ID番号
- N-0072-004-026
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?
医薬品およびデバイス情報、研究文書
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