Postoperative Pain After Bupivacaine Supplementation in Mandibular Fracture Surgery: a Double Blind Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Post-operative pain
研究概览
简要总结
Pain following open reduction of mandibular fractures is the most reported complaint during the first 24 post-operative hours. The goal of this clinical trial is to evaluate the impact of inferior alveolar nerve block with bupivacaine 0,5% in patients with mandibular fractures.
The main question it aims to answer are:
- Does the inferior alveolar nerve block with bupivacaine reduce the intensity of pain after mandibular fracture surgery?
- Does the inferior alveolar nerve block with bupivacaine decrease the consumption of analgesics during the first 24 postoperative hours?
Participants with bifocal mandibular fractures will be enrolled in the study (a fracture should be located on the dentate portion of the right hemi-mandible, and a second fracture located on the dentate portion of the left hemi-mandible). Each patient will receive either a right or left inferior alveolar nerve block.
The patient:
- Will be asked to estimate the pain score by the numerical rating scale during the first 24 postoperative hours for each fracture.
- They will be given rescue analgesia in case of intense pain. The number of uses of rescue analgesia will be noted.
Researchers will compare a group of fracture that will receive the inferior alveolar nerve block with bupivacaine with a group of fracture that will not receive the inferior alveolar nerve block, to see if regional anesthesia improve postoperative pain management of mandibular fractures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with bifocal mandibular fractures ( with one fracture on the dentate portion of the right hemi-mandible, and a second fracture located on the dentate portion of the left hemi-mandible )
- •Proposed for open reduction and internal fixation of their fractures under general anesthesia;
- •Having provided their informed and documented consent on a consent form.
排除标准
- •Pathological mandibular fractures;
- •History of mandibular fractures;
- •Patients with bone involvement in the facial skeleton other than the two fractures of the mandibular dentate portion;
- •Patients suffering from trigeminal neuralgia;
- •Dental care performed in the month preceding the trauma;
- •Patients who have not undergone surgical treatment with open reduction and internal fixation of their mandibular fractures;
- •Patients on anticoagulants;
- •Porphyrias;
- •History of malignant hyperthermia;
- •Known allergy to local anesthetics;
- •Pregnancy or breastfeeding;
- •Severe heart failure;
- •Atrioventricular conduction disorders;
- •Uncontrolled epilepsy;
- •Hemostatic disorders;
- •Non-cooperative patients.
研究组 & 干预措施
Group BNAI+
Randomization process will be used to preoperatively assign patient's left or right side to receive inferior alveolar nerve block. At the end of the surgery, each patient will receive an inferior alveolar nerve block with 2ml of bupivacaine 0.5% on one side ;the other side will not be injected. This arm include the group of fracture which will receive an inferior alveolar nerve block with bupivacaine.
All patient will receive during the postoperative period 1 gram of paracetamol each 8 hours.
干预措施: Bupivacain (Drug)
结局指标
主要结局
Post-operative pain
时间窗: 8 hours post-operatively
questionnaire with a numerical scale (0 - 10)
次要结局
- Post-operative pain(2, 4 , 12, 24 hours post-operatively)
- Adverse effects(24 hours post-operatively)
- The number of instances of rescue analgesia(24 hours post-operatively)
研究者
Yasmine Sanaa
Yasmine Moufida Sanaa , MD
University Tunis El Manar