Protective Analgesia Using Bupivacaine and Conventional Release Ibuprofen Versus Bupivacaine and Sustained Release Ibuprofen for Postoperative Pain Relief in Patients Undergoing Third Molar Surgery: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Number of Patients Needing Rescue Medication
研究概览
简要总结
The purpose of this study is to investigate whether robust analgesic regime (protective analgesia) can improve postoperative pain experience for patients undergoing lower wisdom teeth extraction under day case general anaesthetic.
详细描述
The aim of the study was to demonstrate and improve postoperative pain experience using protective analgesia for patients undergoing oral surgery under day case general anaesthesia.
The primary objective was to investigate the efficiency of protective analgesia using combined effects of sustained release ibuprofen and bupivacaine nerve block in attenuation of postoperative pain following impacted third molar surgery under day case general anaesthesia.
The secondary objective was to document the safety and tolerability profile of conventional release versus sustained released ibuprofen with bupivacaine block in subjects undergoing impacted third molar surgery under day case general anaesthesia.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy male and female patients aged 18 years and over
- •patients requiring removal of one or more third molars, with at lease one completely or partially impacted in the mandible needing bone removal
排除标准
- •history of allergy to NSAIDs
- •history of GI disease
- •history of bleeding disorders
- •alcohol dependancy
- •drug abuse
研究组 & 干预措施
Conventional ibuprofen
干预措施: ibuprofen (Drug)
Conventional ibuprofen
干预措施: Bupivacaine (Drug)
Brufen retard
干预措施: Brufen retard (Drug)
Brufen retard
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Number of Patients Needing Rescue Medication
时间窗: At 6 hours
Number of patients who required rescue medication within 6 hours
次要结局
- Mean Pain Intensity(30 mins, 1 hour, 6 hours, 24 hours and 48 hours after surgery)
- Time to Rescue(Between 30mins and 48 hours)
- Pain Control/Relief(48 hours after surgery (end of study))