Comparison of Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Ultrasound-Guided Erector Spinae Plane Block for Acute Pain Management in Patients With Traumatic Rib Fractures
Comparison of Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Ultrasound-Guided Erector Spinae Plane Block for Acute Pain Management in Patients With Traumatic Rib Fractures: A Prospective Randomized Double-Blind Controlled Study
Traumatic rib fractures cause severe chest wall pain that can impair normal breathing, coughing, and lung function. While systemic opioids are commonly used to treat traumatic pain, their side effects, such as sedation and respiratory depression, can complicate recovery. Regional nerve blocks like the ultrasound-guided erector spinae plane block (ESPB) offer targeted pain relief while minimizing opioid requirements.
The purpose of this clinical trial is to compare the analgesic efficacy and respiratory outcomes of adding dexmedetomidine versus dexamethasone to bupivacaine during an ultrasound-guided ESPB in emergency department patients with acute traumatic rib fractures.
Participants aged 18 to 65 years presenting within 24 hours of rib injury will be randomly assigned to one of two groups:
- Dexmedetomidine Group: Receives an ultrasound-guided ESPB with bupivacaine plus dexmedetomidine.
- Dexamethasone Group: Receives an ultrasound-guided ESPB with bupivacaine plus dexamethasone.
The primary outcome is the duration of analgesia, measured as the time to the first request for rescue pain medication. Secondary outcomes include pain scores at rest and during coughing/deep breathing, total 24-hour opioid consumption, diaphragmatic motion evaluated by ultrasound, respiratory recovery, and the incidence of adverse events over a 24-hour follow-up period.
調査の概要
状態
研究の種類
入学 (推定)
段階
- フェーズ2
- フェーズ 3
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Adult patients aged 18 to 65 years
- Both sexes
- American Society of Anesthesiologists (ASA) physical status I-II
- Acute traumatic rib fractures confirmed by appropriate imaging
- Flail-chest patients who are hemodynamically and respiratory stable to undergo erector spinae plane block (ESPB) and reliable assessment
- Spontaneously breathing patients or patients receiving supplemental oxygen/non-invasive respiratory support without an immediate indication for intubation
- Ability to report pain using a Numeric Rating Scale (NRS)
- Presentation within 24 hours of trauma
- Ability to provide written informed consent
Exclusion Criteria:
- Patient refusal to participate
- Immediate need for endotracheal intubation or invasive mechanical ventilation prior to randomization or block placement
- Hemodynamic instability requiring immediate resuscitation or vasopressor support precluding safe regional anesthesia
- Cardiorespiratory arrest or peri-arrest status
- Severe associated traumatic brain injury or other injuries preventing reliable clinical evaluation
- Major associated injury requiring immediate emergency operative or interventional procedures that prevent protocol completion
- Coagulopathy or any contraindication to regional anesthesia
- Local infection at the anticipated block needle insertion site
- Known allergy to amide local anesthetics, dexmedetomidine, or dexamethasone
- Significant bradyarrhythmia, high-grade atrioventricular block, or contraindication to dexmedetomidine
- Chronic opioid consumption or chronic pain syndromes requiring regular analgesic therapy
- Prior regional anesthesia performed for the current trauma
- Inability to cooperate with the procedure or pain evaluation
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：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：Dexmedetomidine Group
Participants receive an ultrasound-guided erector spinae plane block (ESPB) with bupivacaine plus dexmedetomidine (0.5 mcg/kg) following local skin infiltration with 5 mL of 2% lidocaine.
|
Ultrasound-guided thoracic erector spinae plane block (ESPB) administered deep to the erector spinae muscle and superficial to the transverse process (typically T4-T6) using bupivacaine supplemented with dexmedetomidine (0.5 mcg/kg) following local skin infiltration with 5 mL of 2% lidocaine.
|
|
アクティブコンパレータ：Dexamethasone Group
Participants receive an ultrasound-guided erector spinae plane block (ESPB) with bupivacaine plus dexamethasone (4 mg) following local skin infiltration with 5 mL of 2% lidocaine.
|
Ultrasound-guided thoracic erector spinae plane block (ESPB) administered deep to the erector spinae muscle and superficial to the transverse process (typically T4-T6) using bupivacaine supplemented with dexamethasone (4 mg) following local skin infiltration with 5 mL of 2% lidocaine.
|
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 |
|---|---|---|
|
Time to First Rescue Analgesic Request
時間枠：Up to 24 hours post-block
|
Time (in minutes) from the completion of the ultrasound-guided erector spinae plane block until the patient's first request for rescue analgesia (or when the Numeric Rating Scale score is 4 or greater).
|
Up to 24 hours post-block
|
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
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
- Dexmedetomidine vs Dex in ESPB
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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