The Effect of Using Fentanyl as an Adjuvant to Peribulbar Block to Decrease the Introaoperative Muscle Traction Pain (Proprioception) in Squint and Buckle Surgeries in Adults: RCT
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- pain during muscle traction
研究概览
简要总结
The use of fentanyl as an adjuvant to local anesthetic mixture in many regional blocks. It was effective when used in peribulbar block in cataract and vitreoretinal surgeries.
Our study will assess its efficacy in abolishing pain during muscle traction which is usually a complain for many patients a reason to use systemic opioid intra operatively or even general anesthesia
详细描述
After the patient enters the OR room, an intravenous cannula will be introduced, pulse oximeter, ECG and NIBP monitors will be connected.
Nasal oxygen cannula connected; 10 ml of local anesthetic mixture is injected depending on the group the patient is allocated.
Increments of intravenous intravenous fentanyl and midazolam will be given if patient experienced unbearable pain.
All patient received peribulbar block by an experienced anesthesiologist, both patient and anesthesiologist were blinded to the drug mixture used.
Each patient received 10 ml of the anesthetic mixture according to his/ her group.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA 1, 2 & 3
- •Age 18 to 70
- •Patients undergoing squint or buckle surgeries
排除标准
- •Sensitivity to any drug used in this study
- •Refusal of the patient for peribulbar block
- •Redo squint surgeries or previous buckle insertion
- •High axial length if documented
- •mentally retarded patients and
- •failure of proper communication as in deafness,
- •coagulation abnormalities (INR>1.4),
- •infection at the injection site
研究组 & 干预措施
group f
patient received 50 mic fentanyl as an adjuvant to the local anesthetic mixture applied during peribulbar block in the operative eye
干预措施: Fentanyl (Drug)
group C
received the traditional mixture used
干预措施: Fentanyl (Drug)
结局指标
主要结局
pain during muscle traction
时间窗: Intraoperative period
numeric rating Scale for pain a scale from 0 to 10 where 0 is no pain and 10 is unbearable pain
次要结局
- surgeon satisfaction(intraoperative)