Efficacy of Ropivacaine with or without dexamethasone and Bupivacaine with or without dexamethasone for Local Anesthesia in open reduction and internal fixation of Mandible Fractures: A Triple-Blind Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- 1. To evaluate pain levels intraoperatively and postoperatively.
研究概览
简要总结
Mandibular fractures, the second most common facial fractures after nasal fractures, often require open reduction and internal fixation (ORIF) for optimal anatomical and functional recovery. Effective intraoperative anesthesia and prolonged postoperative analgesia are crucial for patient comfort, reduced complications, and faster recovery. This triple-blind randomized controlled trial aims to compare the efficacy of ropivacaine (0.75%) and bupivacaine (0.5%), each with or without dexamethasone (4 mg/ml), in unilateral isolated mandibular fractures managed via ORIF. Thirty-two patients, meeting strict inclusion criteria and randomized into four equal groups, will undergo standardized local anesthesia techniques, including inferior alveolar, lingual, long buccal nerve blocks, and peri-incisional infiltration. Primary outcomes include intraoperative and postoperative pain scores (Visual Analogue Scale) and duration of analgesia, defined as the time to first rescue analgesic. Secondary outcomes include postoperative swelling (four-line measurement method), incidence of complications, safety profile, and surgical duration. Literature suggests that ropivacaine offers prolonged analgesia with less motor blockade, while bupivacaine, though potent, carries a higher cardiotoxicity risk. Dexamethasone, as an adjuvant, may further prolong analgesia by delaying systemic absorption and reducing inflammation. Data will be statistically analyzed to test the null hypothesis that dexamethasone addition yields no significant benefit over anesthetic alone. This study seeks to address the paucity of comparative evidence between ropivacaine–dexamethasone and bupivacaine–dexamethasone combinations in mandibular fracture surgery, potentially guiding clinicians toward optimal anesthetic protocols for improved patient outcomes, reduced analgesic consumption, and enhanced recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Diagnosed with unilateral, isolated, mandibular fractures confined to the dentate segment requiring ORIF through intra oral approach, confirmed clinically and radiographically.
- •Medically fit to undergo surgery under local anesthesia.
- •Willing to provide informed consent and comply with follow-up visits.
排除标准
- •Patients with additional facial fractures, bilateral mandibular fractures, comminuted fracture, or fractures which require treatment under general anesthesia.
- •History of allergy to local anesthetics or corticosteroids.
- •Patients with systemic conditions affecting healing, such as diabetes, hypertension, osteoporosis, or immunosuppression.
- •Fractures with significant bone loss requiring bone grafting.
结局指标
主要结局
1. To evaluate pain levels intraoperatively and postoperatively.
时间窗: 1. pain levels intraoperatively and postoperatively at 2,4,6,8 hour respectively. | 2.Duration of Analgesia- time interval between the onset of anesthesia and the | patient’s first request for rescue analgesia
2. Record the duration of Analgesia
时间窗: 1. pain levels intraoperatively and postoperatively at 2,4,6,8 hour respectively. | 2.Duration of Analgesia- time interval between the onset of anesthesia and the | patient’s first request for rescue analgesia
次要结局
- 1.reduction in post operative extraoral swelling .(2.incidence of Complications)
研究者
Divyesh Kumar Tanwar
Maulana Azad Institute of Dental Sciences
