Bupivacaine For Postoperative Pain Control
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 主要终点
- POSTOPERATIVE ANALGESIA EXPERIENCED BY THE PATIENTS
研究概览
简要总结
Control of postoperative pain is a foremost goal in achieving a satisfactory postoperative recovery. Surgical removal of lower third molars is accompanied by postoperative pain that is at its peak in the first 12 hours. Our study evaluates if the use of 2% lidocaine hydrochloride for the surgical removal of lower third molars with a postoperative 0.5% bupivacaine supplementation would result in lesser postoperative pain and a decrease in ingestion of oral analgesics to control the pain when compared to a placebo.
详细描述
The study intends to enroll 100 patients [ASA 1] with bilateral symmetrical impacted mandibular third molars requiring surgical removal under local anesthesia. 2% Lidocaine hydrochloride with epinephrine bitartrate 1: 80000 in 3ml quantity will be utilized to achieve local anesthesia at the surgical site on both quadrants. Additional supplementation postoperative at the surgical site will be provided with either 1.5 ml of 0.5% bupivacaine with 1:80000 epinephrine solution or saline based on a split mouth randomized study design using a color and number coded envelop. All procedures will be performed by a single surgeon using a similar technique, under identical conditions at one month apart intervals. Pain scores will be assessed by the patient based on a 10cm Visual Analog Scale at intervals of 2, 4, 6, 12, 24, 36, 48, 72, 96 and 120 hours. The duration of soft tissue anesthesia postoperatively will be recorded by the patient. The number of analgesics ingested over 120 hours will be recorded by the patient. Results will be evaluated statistically by the Wilcoxon test and two tailed test to determine the ratio. Statistical significance will be considered at p < 0.05.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy ASA [American Society of Anaesthesiologists] class 1 patients with mandibular bilateral, symmetrical, impacted third molars indicated for extraction.
排除标准
- •unilateral impacted and bilateral asymmetrical impacted molars;
- •those who misused alcohol, had chronic pain,
- •those who took narcotic drugs, beta-blockers, or any analgesic drug within 24 hours before the operation
- •those with known hypersensitivity to amide types of local anesthetics.
研究组 & 干预措施
BUPIVACAINE GROUP
1.5 ml of 0.5% Bupivacaine solution to be injected into the operative site postoperatively.
干预措施: Bupivacaine (Drug)
PLACEBO GROUP
1.5 ml of saline solution to be injected into the opposite site postoperatively.
干预措施: SALINE (Other)
结局指标
主要结局
POSTOPERATIVE ANALGESIA EXPERIENCED BY THE PATIENTS
时间窗: 5 DAYS
THE PATIENT TO RECORD THE DURATION OF ANALGESIA AFTER SURGICAL REMOVAL OF MANDIBULAR THIRD MOLARS.
次要结局
- ADVERSE EFFECTS FROM INGESTION OF ORAL ANALGESICS(5 DAYS)
- NUMBER OF ORAL ANALGESICS INGESTED AFTER THE SURGICAL REMOVAL OF MANDIBULAR THIRD MOLAR TEETH.(5 DAYS)
- DURATION OF TISSUE ANESTHESIA POSTOPERATIVELY(1.5 TO 10 HOURS)
研究者
pavan MANOHAR PATIL
DIRECTOR
Cosmozone Dental Clinic