Lumbar Disc Disease Clinical Trial
Official title:
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
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.
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.
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