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
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Time to First Rescue Analgesic Request
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Dexmedetomidine with Bupivacaine in ESPB (Drug)
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.
干预措施: Dexamethasone with Bupivacaine in ESPB (Drug)
结局指标
主要结局
Time to First Rescue Analgesic Request
时间窗: 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).
次要结局
未报告次要终点
研究者
Mohamed Elsayed Ali Ibraheim
Resident
Assiut University