Anesthesia With Peribulbar Block: Lidocaine-bupivacaine vs Lidocaine-bupivacaine-fentanyl
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 70
- 主要终点
- Latency period (lost of corneal reflex)
研究概览
简要总结
Ophthalmological procedures such as cataract extraction can be carried out with a peribulbar block (PBB). The advantages of this anesthetic technique include a lower incidence of coughing, unwanted movements and emesis during awakening, in addition to providing adequate postoperative analgesia. The researchers want to investigate whether the use of fentanyl citrate by peribulbar route, when administered with a local anesthetic, shortens the anesthetic latency, interfere with the degree of akinesia and if provides greater postoperative analgesia.
详细描述
Article Type. Clinical trial study
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
- 45 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients scheduled for cataract surgery (Cataract Extracapsular Extraction)
- •With indication of regional anesthesia with peribulbar block
- •Physical status ASA I or II
- •Patients between 45 and 90 years of age
排除标准
- •Allergic to amide-type anesthetics and fentanyl citrate
- •Patients with a history of woody thorax
- •Patients with uncompensated systemic diseases
- •Patients in whom it was necessary to change the anesthetic technique due to insufficient analgesia or those in which the administration of intravenous analgesics was required during the operative period.
研究组 & 干预措施
Group 1 LB
Peribulbar block 1 was performed received 100 mg of lidocaine 5% and 15 mg of bupivacaine 0.5% for a total volume of the anesthetic mixture of 5 ml
干预措施: peribulbar block 1 lidocaine/bupivacaine (Drug)
Group 2 LBF
Peribulbar block 2 was performed received 100 mg of lidocaine 5%, 15 mg of 0.5% bupivacaine and 50 mcg of fentanyl citrate for a total volume of the anesthetic mixture of 6 ml.
干预措施: peribulbar block 2 lidocaine/bupivacaine/fentanyl (Drug)
结局指标
主要结局
Latency period (lost of corneal reflex)
时间窗: 10 minutes until the start of surgery
lost of corneal reflex
次要结局
- Ocular akinesia: movements of extraocular muscles(10 minutes until the start of surgery)
- Incidence of postoperative pain(2 Hours)
- postoperative complications(2 hours)
研究者
Leopoldo Wulff
Principal Investigator, anesthesiologist.
Centro Medico Docente la Trinidad