Bupivacaine in the Treatment of Postoperative Pain of Impacted Third Molar Extraction. A Randomized Clinical Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Pain Intensity Measure: pain visual analog scale
研究概览
简要总结
The third molars are the teeth that are most frequently included and impacted, extraction is one of the most performed treatments by maxillofacial surgeons in their clinical practice. Its surgical extraction is accompanied by an inflammatory process, which generates pain, edema and trismus. The use of alternatives that offer prolonged analgesia, like the use of bupivacaine, reduce the pain of the patient after an extraction of third molars, allows the reduction of morbidity and the rapid return to daily activities.
In addition, it allows a better experience in the dental consultation.
Investigators hypothesis is:
Irrigation of the alveolus with 4 ml of 0.5% bupivacaine is effective for the reduction of post-operative pain in extraction of impacted lower third molars
详细描述
Clinical, randomized, experimental, single blind study. The sample for the present study will consist of 40 patients who attend consecutively to maxillofacial surgery, to perform third molar surgical extraction.
The sample size defined for the present study is 40 patients, each with two extractions of third molars for a total of 80 extractions that will be randomized in each patient for the treatment of Bupivacaine and saline respectively.
For the calculation of statistical power with the sample size previously defined to compare the postoperative pain level 4, 12 and 24 hours after the extraction of lower third molars in two groups (Bupivacaine and saline).
With the sample size, investigators defined, calculated, statistical power, test and use, comparison, pain levels, at 4 and 12 hours, with a power greater than 90%. The study will have sufficient power for the study to be conclusive, regardless of whether it finds statistically significant differences or not.
The surgical procedure will be performed by a single oral and maxillofacial surgeon, following the same surgical technique for the extraction of impacted molars, in all patients, including the sulcular flap up to the second molar, with a posterior complementary incision of 45 degrees, without anterior incision Complementary. The osteotomy is performed with a high speed carbide surgical bur. The patients will not receive a previous medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
The decision to use another substance for the irrigation of the alveolus will be taken in a randomized manner.Through numerical assignment according to the order of surgical scheduling. The patients with even numbers are irrigated on the right side with bupivacaine and on the left side with saline. Patients with odd numbers will be irrigated in the opposite way.
Patients will be considered blinded to the drug of choice, and they will not know what type of solution will be administered on each side.
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Lower third molars impacted bilaterally requiring an osteotomy for their extraction and which are located spatially within the following positions or classes according to Pell & Gregory (1933).
- •Position B (occlusal plane of the impacted tooth between the occlusal plane and the cervical line of the second molar).
- •Position C (tooth impacted below the cervical line of the second molar).
- •Class II (space between the second molar and the mandibular branch smaller than the distal mesial diameter of the third molar).
- •Class III (All or most of the third molar is inside the mandibular branch).
- •Systemically healthy patients (ASA I-II).
排除标准
- •We exclude patients who present a history of infectious processes in the abscess area of third molars or who, for medical reasons, chronically use some type of analgesia.
研究组 & 干预措施
Bupivacaine solution
In all patients, both impacted lower third molars are surgically removed in one session, beginning the extractions in the right side. Subsequently, one of the alveolus will be irrigated with 4ml of bupivacaine 0.5% with adrenaline vasoconstrictor 1: 200,000 (BUPIROP® 0.5% ROPSOHN THERAPEUTICS SAS), the contralateral alveolus will be irrigated with 4 ml of saline solution 0.9% (Baxter laboratories) prior to the placement of the suture for the closure of the surgical wound, using the aspiration to avoid the exit of the medication out of the alveolus.
干预措施: Bupivacaine-epinephrine (Drug)
Saline solution
In all patients, both impacted lower third molars are surgically removed in one session, beginning the extractions in the right side. Subsequently, one of the alveolus will be irrigated with 4ml of bupivacaine 0.5% with adrenaline vasoconstrictor 1: 200,000 (BUPIROP® 0.5% ROPSOHN THERAPEUTICS SAS), the contralateral alveolus will be irrigated with 4 ml of saline solution 0.9% (Baxter laboratories) prior to the placement of the suture for the closure of the surgical wound, using the aspiration to avoid the exit of the medication out of the alveolus.
干预措施: Saline Solution (Drug)
结局指标
主要结局
Change in Pain Intensity Measure: pain visual analog scale
时间窗: 4, 12 and 24 postoperative hours
To identify the analgesia obtained with the alveolus irrigation with bupivacaine at 4, 12 and 24 postoperative hours, by applying the analogous visual pain scale in each third molar object of study. Postoperative pain will be evaluated at 4, 12 and 24 hours after surgery, using the Likert pain visual analog scale from 1 to 10. There being 1 absence of pain and 10 the worst pain imaginable.
次要结局
未报告次要终点
研究者
Pablo Correa
Chief of Posgraduates Programs of Dentistry
CES University