Comparative, Randomized Trial of SPI-directed Intravenous Analgesia Using Metamizole With Tramadol Versus Preemptive Wound Infiltration Using 0,2 % Ropivacaine With Fentanyl or 0,2 % Bupivacaine With Fentanyl for Lumbar Discectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 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 analgesia for lumbar discectomy and compare Numerical Rating Scale (NRS) with Surgical Pleth Index (SPI) for monitoring pain perception postoperatively.
Patients received either preemptive local tissue infiltration at surgical site using either 0,2% ropivacaine with fentanyl or 0,2% bupivacaine with fenthanyl or preemptive intravenous infusion using metamizole and tramadol.
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 parametres constituting a novel approach in monitoring patients intraoperatively, known as adequacy of anaesthesia (AoA) or tailor-made anaesthesia. This study aims at evaluating utility of SPI-directed analgesia in patients undergoing general anaesthesia (GA) where analgesia intraoperatively will be achieved either with regional preemptive wound infiltration using 0,2 % ropivacaine with fentanyl or 0,2 % bupivacaine with fentanyl or intravenous analgesia using continuous infusion of metamizole with tramadol for lumbar discectomy. Intraoperatively, SPI value will be recorded with sampling frequency of 1 minute. When SPI value reaches a level higher than 15 SPI points above basic level, a rescue dose of 1mg/kg body weight of fentanyl will be administered intravenously every 5 minutes until SPI value decreases to basic level calculated previously before operation started.
Additionally, the investigators will compare Numerical Rating Scale (NRS) with Surgical Pleth Index (SPI) values for monitoring the efficacy of analgesia postoperatively. After emergence from GA patients will be questioned in terms of their pain intensity in a scale 0-10. In the case of pain perception above 3, a bolus of 2mg of morphine will be administered intravenously every 10 minutes until pain perception will be lower than 4. SPI values will be recorded every 1 minute and analysed for aute pain (NRS 7-10), average (4-6) and mild pain perception intervals to assess if there exists a correlation between NRS and SPI.
In addition, some patients develop Failed Back Surgery Syndrome (FBSS) following lumbar surgeries so the investigators will aim to analyze if SPI-directed analgesia intra- and post-operatively reduces rate of FBSS. After 5 months after operation patient will be surveyed using melzack protocol to assess the rate of FBSS as well as symptoms of chronic pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 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 with local wound infiltration and surgery of discectomy
排除标准
- •allergy to local anaesthetics
- •necessity of administration of vasoactive drugs influencing SPI monitoring
- •pregnancy
研究组 & 干预措施
bupivacaine, LA, solution
an a local anesthetic administered for local wound infiltration on each side in a single dose of 10 ml of 0,2% solution per segment of vertrebral columne with potential duration time of up to 8 hours according to manufacturers data
干预措施: Metamizol (Drug)
bupivacaine, LA, solution
an a local anesthetic administered for local wound infiltration on each side in a single dose of 10 ml of 0,2% solution per segment of vertrebral columne with potential duration time of up to 8 hours according to manufacturers data
干预措施: Tramadol (Drug)
bupivacaine, LA, solution
an a local anesthetic administered for local wound infiltration on each side in a single dose of 10 ml of 0,2% solution per segment of vertrebral columne with potential duration time of up to 8 hours according to manufacturers data
干预措施: Ropivacaine (Drug)
bupivacaine, LA, solution
an a local anesthetic administered for local wound infiltration on each side in a single dose of 10 ml of 0,2% solution per segment of vertrebral columne with potential duration time of up to 8 hours according to manufacturers data
干预措施: control group (Other)
ropivacaine, LA, solution
an a local anesthetic administered for local wound infiltration on each side in a single dose of 10 ml of 0,2% solution per segment of vertrebral columne with potential duration time of up to 8 hours according to manufacturers data
干预措施: Metamizol (Drug)
ropivacaine, LA, solution
an a local anesthetic administered for local wound infiltration on each side in a single dose of 10 ml of 0,2% solution per segment of vertrebral columne with potential duration time of up to 8 hours according to manufacturers data
干预措施: Tramadol (Drug)
ropivacaine, LA, solution
an a local anesthetic administered for local wound infiltration on each side in a single dose of 10 ml of 0,2% solution per segment of vertrebral columne with potential duration time of up to 8 hours according to manufacturers data
干预措施: Bupivacaine (Drug)
ropivacaine, LA, solution
an a local anesthetic administered for local wound infiltration on each side in a single dose of 10 ml of 0,2% solution per segment of vertrebral columne with potential duration time of up to 8 hours according to manufacturers data
干预措施: control group (Other)
metamizol, analgesic, solution
an analgesic drug administered intravenously for pre-emptive analgesia in a initial dose of 1-1,25g with potential duration time of up to 6 hours according to manufacturers data
干预措施: Bupivacaine (Drug)
metamizol, analgesic, solution
an analgesic drug administered intravenously for pre-emptive analgesia in a initial dose of 1-1,25g with potential duration time of up to 6 hours according to manufacturers data
干预措施: Ropivacaine (Drug)
metamizol, analgesic, solution
an analgesic drug administered intravenously for pre-emptive analgesia in a initial dose of 1-1,25g with potential duration time of up to 6 hours according to manufacturers data
干预措施: control group (Other)
tramadol, analgesic, solution
a half-opioid drug administered intravenously for pre-emptive analgesia in a initial dose of 2 mg per kg of body weight with potential duration time of up to 6 hours according to manufacturers data
干预措施: Metamizol (Drug)
tramadol, analgesic, solution
a half-opioid drug administered intravenously for pre-emptive analgesia in a initial dose of 2 mg per kg of body weight with potential duration time of up to 6 hours according to manufacturers data
干预措施: Tramadol (Drug)
tramadol, analgesic, solution
a half-opioid drug administered intravenously for pre-emptive analgesia in a initial dose of 2 mg per kg of body weight with potential duration time of up to 6 hours according to manufacturers data
干预措施: Bupivacaine (Drug)
tramadol, analgesic, solution
a half-opioid drug administered intravenously for pre-emptive analgesia in a initial dose of 2 mg per kg of body weight with potential duration time of up to 6 hours according to manufacturers data
干预措施: Ropivacaine (Drug)
control group
no pre-emptive analgesia will be used.
干预措施: Metamizol (Drug)
control group
no pre-emptive analgesia will be used.
干预措施: Tramadol (Drug)
control group
no pre-emptive analgesia will be used.
干预措施: Bupivacaine (Drug)
control group
no pre-emptive analgesia will be used.
干预措施: Ropivacaine (Drug)
control group
no pre-emptive analgesia will be used.
干预措施: control group (Other)
结局指标
主要结局
pain perception intraoperatively
时间窗: on-line based on SPI values
The investigators will compare the efficacy of analgesia intraoperatively according to technique of analgesia used preoperatively: either local woung inflitration or intravenous infusion. The investigators will administer a resuce dose of fentanyl intravenously in a dose of 1 mcg per kg of body weight in the case when SPI value increases over 15 points in SPI scale every 5 minutes untill SPI value decreases back to baseline value
次要结局
- pain perception postoperatively(2 hours after discharge to postoperative unit.)
研究者
Michał Stasiowski
Principal Investigator, 2Department of Anaesthesiology and Intensive Therapy
Medical University of Silesia