Subtenon Block Combined With General Anesthesia for Vitreoretinal Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- the time to first postoperative analgesic dose
研究概览
简要总结
To evaluate the effects of subtenon block (SB) as an adjunct to general anaesthesia on postoperative pain, oculocardiac reflex and postoperative nausea and vomiting for vitreoretinal surgery.
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
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient undergoing elective retinal surgery under general anesthesia
排除标准
- •ASA physical status > Grade II,
- •psychiatric conditions,
- •neurological impairment,
- •deafness with whom communication would be difficult in the postoperative period,
- •clotting abnormalities,
- •contraindications for regional anesthesia,
- •drug abuse,
- •history of allergy to the study drugs,
- •previous vitreoretinal or strabismus surgery,
- •endophthalmitis, or inflammatory eye pathology
- •taking analgesics, antiemetics or drugs that might affect hemodynamics
研究组 & 干预措施
SB
receive subtenon block of 4mL of 2% lidocaine and 0.5% bupivacaine (50:50) mixture
干预措施: 2% lidocaine and 0.5% bupivacaine (Drug)
C
receive subtenon block of 4mL saline
干预措施: Sham subtenon block (Drug)
结局指标
主要结局
the time to first postoperative analgesic dose
时间窗: 24 hrs
Pain was evaluated using a VNS chart (0-no pain at all, 10-the worst pain imaginable) at 30 min, 1, 2, 4, 6, 12,18 and 24 hours postoperatively. During PACU stay, if the patient complain of pain postoperatively (VNS ≥ 4), morphine boluses of 25 µg /kg (injected at 10-min intervals) was administered intravenously if requested until the pain subsided for a maximum dose of 10 mg. At the end of 2 h, the patients were transferred from the PACU to the ward where the pain was assessed, paracetamol 15 mg/kg was given intravenously and was repeated every 4 hours if needed in the ward by a nurse who is blinded to the study group as paracetamol is the standard post-operative pain medication for patients undergoing ophthalmic surgery at our institute. Time to first post-operative analgesic, which is the time, elapsed between end of the surgical procedure and first administration of an analgesic was noted
次要结局
- number of patients requiring rescue analgesics during the 24-h study period(during the whole study (6 months))
- postoperative pain scores(First 24 hrs after surgery)
- incidence of postoperative nausea/vomiting(First 24 hrs after surgery)
- consumption of rescue analgesics(during the whole study (6 months))
- incidence of oculocardiac reflex(during time of surgery)
研究者
Marwan Abouammoh
Associate professor
King Saud University