Postoperative Analgesia in Third Molar Surgery Under General Anesthesia: Ropivacaine Versus Placebo
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 24 hour area under the curve for pain
研究概览
简要总结
The main objective of this study is to demonstrate the superiority of local analgesia with ropivacaine versus placebo on postoperative pain during the first 24 hours following bilateral surgery of all four third molars under general anesthesia.
详细描述
The secondary objectives of this study are to compare regional anesthesia by ropivacaine versus placebo for the bilateral resection of all four third molars under general anesthesia, in terms of:
A. intraoperative use of propofol and remifentanil B. postoperative pain (EVN) at different time points C. in-hospital analgesic consumption D. time to first rescue analgesic request E. time spent in the post interventional treatment room F. length of hospital stay G. side effects H. analgesic consumption at home I. analgesic consumption (total) J. patient satisfaction K. Chronic pain after surgery
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient is available for 3 months of follow-up
- •American Society of Anesthesiology (ASA) score of 1, 2 or 3
- •Patient programmed for surgical removal of all 4 wisdom teeth, excluding all other teeth, under general anesthesia
排除标准
- •The patient is participating in another study
- •The patient is in an exclusion period determined by a previous study
- •The patient is over 18 years old and under judicial protection, under tutorship or curatorship
- •The patient (or legal representative)refuses to sign the consent
- •It is impossible to correctly inform the patient
- •The patient is pregnant, parturient, or breastfeeding
- •Ineffective contraceptive
- •Addiction or chronic pain treated with morphine
- •Contra-indication for regional anesthesia (eg congenital or acquired coagulopathy, infection, allergy)
- •Contra-indication to local anesthetics, general anesthetics and analgesics used in the protocol.
- •Difficult cooperation, psychiatric disorders that could interfere with assessments
- •Hypersensitivity to ropivacaine or other local anesthetics with amide links
- •Contra-indication for the use of NaCl 0.9%: all states of sodium and water retention (especially heart failure, edema and ascites syndrome associated with cirrhosis)
研究组 & 干预措施
Placebo
Patients in this arm will have standard anesthesia with the injection of placebo solution into the vestibular of each tooth to be extracted
干预措施: Placebo injection (Drug)
Ropivacaine
Patients in this arm will have general anesthesia with injection of ropivacaine into the vestibular next to each tooth to be extracted.
干预措施: Ropivacaine injection (Drug)
结局指标
主要结局
24 hour area under the curve for pain
时间窗: 24 hours
Pain is assessed via a numeric, verbal scale (0 to 10) at baseline and then at 1.5, 2, 3, 4, 6 and 24 hours after surgery. The area under the resulting curve is calculated.
次要结局
- Total peroperative consumption of remifentanil(During surgery (approximately 30-50 minutes))
- Total peroperative consumption of propofol(During surgery (approximately 30-50 minutes))
- Post operative pain as measured by a verbal, numeric scale (0 to 10)(3 months)
- Total morphine consumption(Hospital discharge (on average on days 1 or 2))
- Use of rescue pain medicine (yes/no)(Hospital discharge (on average on days 1 or 2))
- Total in-hospital Tramadol consumption(Hospital discharge (on average on days 1 or 2))
- Total in-hospital paracetamol consumption(Hospital discharge (on average on days 1 or 2))
- Total in-hospital ketoprofen consumption(Hospital discharge (on average on days 1 or 2))
- Time elapsed between release from post-surgical recovery room and first request for rescue medicine(Hospital discharge (on average on days 1 or 2))
- Length of recovery room stay(Recovery room discharge (Day 1))
- Length of hospital stay(Hospital discharge (on average on days 1 or 2))
- presence/absence of complications(day 3)
- Paracetamol consumption at home(Day 3)
- ketoprofen consumption at home(Day 3)
- Tramadol consumption at home(Day 3)
- Patient satisfaction(Day 3)
- Chronic pain evaluation (DN4)(3 months)