Clinical trial NCT02971540: SPI-directed Analgesia for Lumbar Discectomy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Disc Disease
Keywords: Surgical Pleth Index (SPI)
General Anaesthesia (GA),
Numerical Rating Scale (NRS)
Adequacy of Anaesthesia (AoA
Spectral Entropy (SE)
Local Anesthetic (LA)
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
Collaborators: name: Silesian University of Medicine
First posted: 2016-11-23
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: Inclusion Criteria:

* written consent to participate in the study
* written consent to undergo general anaesthesia with local wound infiltration and surgery of discectomy

Exclusion Criteria:

* allergy to local anaesthetics
* necessity of administration of vasoactive drugs influencing SPI monitoring
* pregnancy

Primary outcomes:
measure: pain perception intraoperatively
timeFrame: on-line based on SPI values
Secondary outcomes:
measure: pain perception postoperatively
timeFrame: 2 hours after discharge to postoperative unit.
Other outcomes:
measure: postoperative persistent pain
timeFrame: up to 6 months
measure: postoperative FBSS
timeFrame: up to 6 months
Locations:
city: Sosnowiec
country: Poland
facility: Medical University of Silesia
state: Silesia
Study officials:
affiliation: Medical University of Silesia
name: Michał J Stasiowski, M.D
role: PRINCIPAL_INVESTIGATOR
References:
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