SPI-directed Analgesia for Lumbar Discectomy
Condition: Lumbar Disc Disease
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Metamizol; Tramadol; Bupivacaine; Ropivacaine; control group
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention description(s): in group A patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1-1,25 gram with following intravenous infusion of 5 grams per day.; in group A patients will receive pre-emptive analgesia using intravenous infusion of tramadol in a single dose of 2 mg per hg of body weight with following intravenous infusion of 400 mg per day.; patients in group BF will receive local wound infiltration with a solution of 0,2% bupivacaine in a volume of 10 ml per segment of vertrebral columne.; patients in group RF will receive local wound infiltration with a solution of 0,2% ropivacaine in a volume of 10 ml per segment of vertrebral columne.; patients will receive no pre-emptive analgesia. intraoperatively standard dose of fentanyl will be used.
Other intervention name(s): Pyralgina; Poltram; Bupiwakaina WZF; Ropimol
Intervention MeSH terms: Dipyrone; Tramadol; Bupivacaine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Surgical Pleth Index (SPI); General Anaesthesia (GA),; Numerical Rating Scale (NRS); Adequacy of Anaesthesia (AoA; Spectral Entropy (SE); Local Anesthetic (LA)