Influence of SPI-guided Analgesia With Preventive Different Peribulbar Blocks (PBB) on the Presence of OCR, Postoperative Pain, PONV in Patients Undergoing VRS Under General Anaesthesia: a Randomised, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 2
- 主要终点
- pain perception intraoperatively
研究概览
简要总结
The aim of this randomized trial is to assess the efficacy of preventive analgesia using different peribulbar blocks (PBB) under SPI-guided anaesthesia for vitreoretinal surgery (VRS), presence of PONV (postoperative nausea and vomiting) and oculocardiac reflex (OCR) and compare Numerical Rating Scale (NRS) with Surgical Pleth Index (SPI) for monitoring pain perception postoperatively.
Patients will receive general anaesthesia combined with either preventive PBB using either lidocaine with bupivacaine or bupivacaine or ropivacaine
详细描述
Monitoring depth of anaesthesia using spectral entropy (SE) and quality of neuromuscular block are routine in modern anaesthesia, whereas monitoring of analgesia still requires further studies. Recently, the Surgical Pleth Index (SPI) was added as a surrogate variable showing the nociception-antinociception balance into abovementioned parameters constituting a novel approach in monitoring patients intraoperatively, known as adequacy of anaesthesia (AoA) or tailor-made anaesthesia.
Different options of local anesthetic mixtures used for peribulbar block result in different analgetic potency. PBB is supposed to reduce requirement for intraoperative narcotic analgesics when used together with general anaesthesia and therefore may reduce the rate of PONV, OCR and perception of postoperative pain.
The aim of the study is to investigate the influence of different PBBs on abovementioned outcomes.
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, Outcomes Assessor)
盲法说明
Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written consent to participate in the study written consent to undergo general anaesthesia alone or combined with different techniques of pre-emptive analgesia and vitreoretinal surgery
排除标准
- •history of allergy to local anaesthetics or paracetamol necessity of administration of vasoactive drugs influencing SPI monitoring pregnancy
研究组 & 干预措施
paracetamol
in P group patients will receive preemptive analgesia using 1 gram of paracetamol before induction of general anaesthesia
干预措施: 0,5 % bupivacaine with of 2% lidocaine (Drug)
1 % ropivacaine
in group RL patients in group BF will receive regional peribulbar block using a solution of 1% ropivacaine (5 ml)
干预措施: 0,5 % bupivacaine (Drug)
1 % ropivacaine
in group RL patients in group BF will receive regional peribulbar block using a solution of 1% ropivacaine (5 ml)
干预措施: 0,5 % bupivacaine with of 2% lidocaine (Drug)
0,5 % bupivacaine with of 2% lidocaine
in group BL patients in group BF will receive regional peribulbar block using a solution of 0,5% bupivacaine (2,5 ml) with 2% lidocaine (2,5 ml)
干预措施: paracetamol (Drug)
0,5 % bupivacaine with of 2% lidocaine
in group BL patients in group BF will receive regional peribulbar block using a solution of 0,5% bupivacaine (2,5 ml) with 2% lidocaine (2,5 ml)
干预措施: 0,5 % bupivacaine (Drug)
0,5 % bupivacaine with of 2% lidocaine
in group BL patients in group BF will receive regional peribulbar block using a solution of 0,5% bupivacaine (2,5 ml) with 2% lidocaine (2,5 ml)
干预措施: 1 % Ropivacaine (Drug)
0,5 % bupivacaine
in group B patients in group BF will receive regional peribulbar block using a solution of 0,5% bupivacaine (5 ml)
干预措施: 0,5 % bupivacaine with of 2% lidocaine (Drug)
0,5 % bupivacaine
in group B patients in group BF will receive regional peribulbar block using a solution of 0,5% bupivacaine (5 ml)
干预措施: 1 % Ropivacaine (Drug)
paracetamol
in P group patients will receive preemptive analgesia using 1 gram of paracetamol before induction of general anaesthesia
干预措施: 0,5 % bupivacaine (Drug)
paracetamol
in P group patients will receive preemptive analgesia using 1 gram of paracetamol before induction of general anaesthesia
干预措施: 1 % Ropivacaine (Drug)
0,5 % bupivacaine
in group B patients in group BF will receive regional peribulbar block using a solution of 0,5% bupivacaine (5 ml)
干预措施: paracetamol (Drug)
1 % ropivacaine
in group RL patients in group BF will receive regional peribulbar block using a solution of 1% ropivacaine (5 ml)
干预措施: paracetamol (Drug)
结局指标
主要结局
pain perception intraoperatively
时间窗: intraoperative assessment
The investigators will compare the efficacy of analgesia intraoperatively according to technique of analgesia used preoperatively: either peribulbar block or intravenous infusion. The investigators will administer a rescue dose of fentanyl intravenously in a dose of 1 mcg per kg of body weight in the case when SPI (surgical pleh index value) value increases over 15 points in SPI scale every 5 minutes until SPI value decreases back to baseline value. Additionally, the investigators will analyse rescue fentanyl consumption in abovementioned groups
次要结局
- pain perception postoperatively(up to one hour after discharge to postoperative unit performed every 10 minutes.)
- oculocardiac reflex rate(intraoperative assessment)
- PONV (postoperative nausea and vomiting)(postoperative assessment up to 24 hours)