<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02971540</url>
  </required_header>
  <id_info>
    <org_study_id>SilesianMUKOAiIT1</org_study_id>
    <nct_id>NCT02971540</nct_id>
  </id_info>
  <brief_title>SPI-directed Analgesia for Lumbar Discectomy</brief_title>
  <acronym>SPI</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Silesia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Silesian University of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of Silesia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this randomized trial is to assess the efficacy of analgesia for lumbar discectomy&#xD;
      and compare Numerical Rating Scale (NRS) with Surgical Pleth Index (SPI) for monitoring pain&#xD;
      perception postoperatively.&#xD;
&#xD;
      Patients received either preemptive local tissue infiltration at surgical site using either&#xD;
      0,2% ropivacaine with fentanyl or 0,2% bupivacaine with fenthanyl or preemptive intravenous&#xD;
      infusion using metamizole and tramadol.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Monitoring depth of anaesthesia using spectral entropy (SE) and quality of neuromuscular&#xD;
      block are routine in modern anaesthesia, whereas monitoring of analgesia still requires&#xD;
      further studies. Recently, the Surgical Pleth Index (SPI) was added as a surrogate variable&#xD;
      showing the nociception-antinociception balance into abovementioned parametres constituting a&#xD;
      novel approach in monitoring patients intraoperatively, known as adequacy of anaesthesia&#xD;
      (AoA) or tailor-made anaesthesia. This study aims at evaluating utility of SPI-directed&#xD;
      analgesia in patients undergoing general anaesthesia (GA) where analgesia intraoperatively&#xD;
      will be achieved either with regional preemptive wound infiltration using 0,2 % ropivacaine&#xD;
      with fentanyl or 0,2 % bupivacaine with fentanyl or intravenous analgesia using continuous&#xD;
      infusion of metamizole with tramadol for lumbar discectomy. Intraoperatively, SPI value will&#xD;
      be recorded with sampling frequency of 1 minute. When SPI value reaches a level higher than&#xD;
      15 SPI points above basic level, a rescue dose of 1mg/kg body weight of fentanyl will be&#xD;
      administered intravenously every 5 minutes until SPI value decreases to basic level&#xD;
      calculated previously before operation started.&#xD;
&#xD;
      Additionally, the investigators will compare Numerical Rating Scale (NRS) with Surgical Pleth&#xD;
      Index (SPI) values for monitoring the efficacy of analgesia postoperatively. After emergence&#xD;
      from GA patients will be questioned in terms of their pain intensity in a scale 0-10. In the&#xD;
      case of pain perception above 3, a bolus of 2mg of morphine will be administered&#xD;
      intravenously every 10 minutes until pain perception will be lower than 4. SPI values will be&#xD;
      recorded every 1 minute and analysed for aute pain (NRS 7-10), average (4-6) and mild pain&#xD;
      perception intervals to assess if there exists a correlation between NRS and SPI.&#xD;
&#xD;
      In addition, some patients develop Failed Back Surgery Syndrome (FBSS) following lumbar&#xD;
      surgeries so the investigators will aim to analyze if SPI-directed analgesia intra- and&#xD;
      post-operatively reduces rate of FBSS. After 5 months after operation patient will be&#xD;
      surveyed using melzack protocol to assess the rate of FBSS as well as symptoms of chronic&#xD;
      pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2016</start_date>
  <completion_date type="Actual">July 30, 2017</completion_date>
  <primary_completion_date type="Actual">July 30, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pain perception intraoperatively</measure>
    <time_frame>on-line based on SPI values</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>pain perception postoperatively</measure>
    <time_frame>2 hours after discharge to postoperative unit.</time_frame>
    <description>The investigators will compare the efficacy of analgesia postoperatively according to technique of analgesia used preoperatively: either local woung inflitration or intravenous infusion. The investigators use NRS and compare it with SPI values. Additionally, The investigators will observe SPI variations as a reaction to morphine administration intravenously in the case of acute or moderate pain.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>postoperative persistent pain</measure>
    <time_frame>up to 6 months</time_frame>
    <description>The investigators will compare the efficacy of analgesia postoperatively according to technique of analgesia used preoperatively: either local woung inflitration or intravenous infusion. The investigators will use melzack to assess the rate of the post-operative persistent pain. Patients will be invited to pay a control visit in the clinic and asked to describe their pain intensity and specify its characteristic using a set of adjectives characterizing their pain perception. Afterwards, pain perception of patients will be analyzed using specified scale when each adjective is attributed points and sum of points gathered in the questionaire indicates probability of presence of postoperative perception pain using melzack questionnaire.</description>
  </other_outcome>
  <other_outcome>
    <measure>postoperative FBSS</measure>
    <time_frame>up to 6 months</time_frame>
    <description>The investigators will compare the efficacy of analgesia postoperatively according to technique of analgesia used preoperatively: either local woung inflitration or intravenous infusion. The investigators will use FBSS scale to assess the presence of FBSS. Patients will be invited to pay a control visit in the clinic to be diagnosed for symptoms of FBSS: pain intensity, disability, depression scores, temperament and character profile determined by the visual analogue scale (VAS), Roland Morris Disability Index, Beck Depression Inventory, and Temperament and Character Inventory.</description>
  </other_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">132</enrollment>
  <condition>Lumbar Disc Disease</condition>
  <arm_group>
    <arm_group_label>bupivacaine, LA, solution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ropivacaine, LA, solution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>metamizol, analgesic, solution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>tramadol, analgesic, solution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>no pre-emptive analgesia will be used.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metamizol</intervention_name>
    <description>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.</description>
    <arm_group_label>bupivacaine, LA, solution</arm_group_label>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>ropivacaine, LA, solution</arm_group_label>
    <arm_group_label>tramadol, analgesic, solution</arm_group_label>
    <other_name>Pyralgina</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tramadol</intervention_name>
    <description>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.</description>
    <arm_group_label>bupivacaine, LA, solution</arm_group_label>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>ropivacaine, LA, solution</arm_group_label>
    <arm_group_label>tramadol, analgesic, solution</arm_group_label>
    <other_name>Poltram</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>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.</description>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>metamizol, analgesic, solution</arm_group_label>
    <arm_group_label>ropivacaine, LA, solution</arm_group_label>
    <arm_group_label>tramadol, analgesic, solution</arm_group_label>
    <other_name>Bupiwakaina WZF</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ropivacaine</intervention_name>
    <description>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.</description>
    <arm_group_label>bupivacaine, LA, solution</arm_group_label>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>metamizol, analgesic, solution</arm_group_label>
    <arm_group_label>tramadol, analgesic, solution</arm_group_label>
    <other_name>Ropimol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>control group</intervention_name>
    <description>patients will receive no pre-emptive analgesia. intraoperatively standard dose of fentanyl will be used.</description>
    <arm_group_label>bupivacaine, LA, solution</arm_group_label>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>metamizol, analgesic, solution</arm_group_label>
    <arm_group_label>ropivacaine, LA, solution</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  written consent to participate in the study&#xD;
&#xD;
          -  written consent to undergo general anaesthesia with local wound infiltration and&#xD;
             surgery of discectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  allergy to local anaesthetics&#xD;
&#xD;
          -  necessity of administration of vasoactive drugs influencing SPI monitoring&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michał J Stasiowski, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Silesia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of Silesia</name>
      <address>
        <city>Sosnowiec</city>
        <state>Silesia</state>
        <zip>41-200</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <reference>
    <citation>Gruenewald M, Ilies C, Herz J, Schoenherr T, Fudickar A, Hocker J, Bein B. Influence of nociceptive stimulation on analgesia nociception index (ANI) during propofol-remifentanil anaesthesia. Br J Anaesth. 2013 Jun;110(6):1024-30. doi: 10.1093/bja/aet019. Epub 2013 Mar 6.</citation>
    <PMID>23471754</PMID>
  </reference>
  <reference>
    <citation>Gruenewald M, Ilies C. Monitoring the nociception-anti-nociception balance. Best Pract Res Clin Anaesthesiol. 2013 Jun;27(2):235-47. doi: 10.1016/j.bpa.2013.06.007.</citation>
    <PMID>24012235</PMID>
  </reference>
  <reference>
    <citation>Gruenewald M, Willms S, Broch O, Kott M, Steinfath M, Bein B. Sufentanil administration guided by surgical pleth index vs standard practice during sevoflurane anaesthesia: a randomized controlled pilot study. Br J Anaesth. 2014 May;112(5):898-905. doi: 10.1093/bja/aet485. Epub 2014 Feb 16.</citation>
    <PMID>24535604</PMID>
  </reference>
  <reference>
    <citation>Won YJ, Lim BG, Lee SH, Park S, Kim H, Lee IO, Kong MH. Comparison of relative oxycodone consumption in surgical pleth index-guided analgesia versus conventional analgesia during sevoflurane anesthesia: A randomized controlled trial. Medicine (Baltimore). 2016 Aug;95(35):e4743. doi: 10.1097/MD.0000000000004743.</citation>
    <PMID>27583920</PMID>
  </reference>
  <reference>
    <citation>Cherian MN, Mathews MP, Chandy MJ. Local wound infiltration with bupivacaine in lumbar laminectomy. Surg Neurol. 1997 Feb;47(2):120-2; discussion 122-3. doi: 10.1016/s0090-3019(96)00255-8.</citation>
    <PMID>9040811</PMID>
  </reference>
  <reference>
    <citation>Hernandez-Palazon J, Tortosa Serrano JA, Burguillos Lopez S, Molero Molero E. [Infiltration of the surgical wound with local anesthetic for postoperative analgesia in patients operated on for lumbar disc herniation. Comparative study of ropivacaine and bupivacaine]. Rev Esp Anestesiol Reanim. 2001 Jan;48(1):17-20. Spanish.</citation>
    <PMID>11234601</PMID>
  </reference>
  <reference>
    <citation>Gurbet A, Bekar A, Bilgin H, Korfali G, Yilmazlar S, Tercan M. Pre-emptive infiltration of levobupivacaine is superior to at-closure administration in lumbar laminectomy patients. Eur Spine J. 2008 Sep;17(9):1237-41. doi: 10.1007/s00586-008-0676-z. Epub 2008 Apr 19.</citation>
    <PMID>18425538</PMID>
  </reference>
  <reference>
    <citation>Ozyilmaz K, Ayoglu H, Okyay RD, Yurtlu S, Koksal B, Hanci V, Erdogan G, Turan IO. Postoperative analgesic effects of wound infiltration with tramadol and levobupivacaine in lumbar disk surgeries. J Neurosurg Anesthesiol. 2012 Oct;24(4):331-5. doi: 10.1097/ANA.0b013e3182611a1d.</citation>
    <PMID>22759866</PMID>
  </reference>
  <reference>
    <citation>Chae SU, Kim TK, Shim DM, Kim YJ, Choi DH. Is complex regional pain syndrome a cause of post-operative syndrome in the lumbar spine? - a case report -. Asian Spine J. 2009 Dec;3(2):101-5. doi: 10.4184/asj.2009.3.2.101. Epub 2009 Dec 31.</citation>
    <PMID>20404955</PMID>
  </reference>
  <reference>
    <citation>Yalbuzdag SA, Erol AM, Sengul I, Celik C, Solum S, Adilay HU, Gungor B. Temperament and Character Profile in Failed Back Surgery Syndrome: A Cross-Sectional Clinical Study. Turk Neurosurg. 2016;26(6):912-917. doi: 10.5137/1019-5149.JTN.13679-14.0.</citation>
    <PMID>27476913</PMID>
  </reference>
  <results_reference>
    <citation>Gruenewald M, Herz J, Schoenherr T, Thee C, Steinfath M, Bein B. Measurement of the nociceptive balance by Analgesia Nociception Index and Surgical Pleth Index during sevoflurane-remifentanil anesthesia. Minerva Anestesiol. 2015 May;81(5):480-9. Epub 2014 Jul 17.</citation>
    <PMID>25032676</PMID>
  </results_reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>November 2, 2016</study_first_submitted>
  <study_first_submitted_qc>November 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>April 14, 2019</last_update_submitted>
  <last_update_submitted_qc>April 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Silesia</investigator_affiliation>
    <investigator_full_name>Michał Stasiowski</investigator_full_name>
    <investigator_title>Principal Investigator, 2Department of Anaesthesiology and Intensive Therapy</investigator_title>
  </responsible_party>
  <keyword>Surgical Pleth Index (SPI)</keyword>
  <keyword>General Anaesthesia (GA),</keyword>
  <keyword>Numerical Rating Scale (NRS)</keyword>
  <keyword>Adequacy of Anaesthesia (AoA</keyword>
  <keyword>Spectral Entropy (SE)</keyword>
  <keyword>Local Anesthetic (LA)</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dipyrone</mesh_term>
    <mesh_term>Tramadol</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
    <mesh_term>Ropivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>article in AiIT in 2019,</ipd_description>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02971540
org study id: SilesianMUKOAiIT1
nct id: NCT02971540
lead sponsor: 
collaborator: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Participant)
measure: pain perception intraoperatively
time frame: on-line based on SPI values
description: 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
measure: pain perception postoperatively
time frame: 2 hours after discharge to postoperative unit.
description: The investigators will compare the efficacy of analgesia postoperatively according to technique of analgesia used preoperatively: either local woung inflitration or intravenous infusion. The investigators use NRS and compare it with SPI values. Additionally, The investigators will observe SPI variations as a reaction to morphine administration intravenously in the case of acute or moderate pain.
measure: postoperative persistent pain
time frame: up to 6 months
description: The investigators will compare the efficacy of analgesia postoperatively according to technique of analgesia used preoperatively: either local woung inflitration or intravenous infusion. The investigators will use melzack to assess the rate of the post-operative persistent pain. Patients will be invited to pay a control visit in the clinic and asked to describe their pain intensity and specify its characteristic using a set of adjectives characterizing their pain perception. Afterwards, pain perception of patients will be analyzed using specified scale when each adjective is attributed points and sum of points gathered in the questionaire indicates probability of presence of postoperative perception pain using melzack questionnaire.
measure: postoperative FBSS
time frame: up to 6 months
description: The investigators will compare the efficacy of analgesia postoperatively according to technique of analgesia used preoperatively: either local woung inflitration or intravenous infusion. The investigators will use FBSS scale to assess the presence of FBSS. Patients will be invited to pay a control visit in the clinic to be diagnosed for symptoms of FBSS: pain intensity, disability, depression scores, temperament and character profile determined by the visual analogue scale (VAS), Roland Morris Disability Index, Beck Depression Inventory, and Temperament and Character Inventory.
arm group label: bupivacaine, LA, solution
arm group type: Experimental
description: 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
arm group label: ropivacaine, LA, solution
arm group type: Experimental
description: 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
arm group label: metamizol, analgesic, solution
arm group type: Experimental
description: 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
arm group label: tramadol, analgesic, solution
arm group type: Experimental
description: 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
arm group label: control group
arm group type: Experimental
description: no pre-emptive analgesia will be used.
intervention type: Drug
intervention name: Metamizol
description: 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.
arm group label: bupivacaine, LA, solution
arm group label: control group
arm group label: ropivacaine, LA, solution
arm group label: tramadol, analgesic, solution
other name: Pyralgina
intervention type: Drug
intervention name: Tramadol
description: 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.
arm group label: bupivacaine, LA, solution
arm group label: control group
arm group label: ropivacaine, LA, solution
arm group label: tramadol, analgesic, solution
other name: Poltram
intervention type: Drug
intervention name: Bupivacaine
description: 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.
arm group label: control group
arm group label: metamizol, analgesic, solution
arm group label: ropivacaine, LA, solution
arm group label: tramadol, analgesic, solution
other name: Bupiwakaina WZF
intervention type: Drug
intervention name: Ropivacaine
description: 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.
arm group label: bupivacaine, LA, solution
arm group label: control group
arm group label: metamizol, analgesic, solution
arm group label: tramadol, analgesic, solution
other name: Ropimol
intervention type: Other
intervention name: control group
description: patients will receive no pre-emptive analgesia. intraoperatively standard dose of fentanyl will be used.
arm group label: bupivacaine, LA, solution
arm group label: control group
arm group label: metamizol, analgesic, solution
arm group label: ropivacaine, LA, solution
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Michał J Stasiowski, M.D
role: Principal Investigator
affiliation: Medical University of Silesia
facility: 
country: Poland
citation: Gruenewald M, Ilies C, Herz J, Schoenherr T, Fudickar A, Hocker J, Bein B. Influence of nociceptive stimulation on analgesia nociception index (ANI) during propofol-remifentanil anaesthesia. Br J Anaesth. 2013 Jun;110(6):1024-30. doi: 10.1093/bja/aet019. Epub 2013 Mar 6.
PMID: 23471754
citation: Gruenewald M, Ilies C. Monitoring the nociception-anti-nociception balance. Best Pract Res Clin Anaesthesiol. 2013 Jun;27(2):235-47. doi: 10.1016/j.bpa.2013.06.007.
PMID: 24012235
citation: Gruenewald M, Willms S, Broch O, Kott M, Steinfath M, Bein B. Sufentanil administration guided by surgical pleth index vs standard practice during sevoflurane anaesthesia: a randomized controlled pilot study. Br J Anaesth. 2014 May;112(5):898-905. doi: 10.1093/bja/aet485. Epub 2014 Feb 16.
PMID: 24535604
citation: Won YJ, Lim BG, Lee SH, Park S, Kim H, Lee IO, Kong MH. Comparison of relative oxycodone consumption in surgical pleth index-guided analgesia versus conventional analgesia during sevoflurane anesthesia: A randomized controlled trial. Medicine (Baltimore). 2016 Aug;95(35):e4743. doi: 10.1097/MD.0000000000004743.
PMID: 27583920
citation: Cherian MN, Mathews MP, Chandy MJ. Local wound infiltration with bupivacaine in lumbar laminectomy. Surg Neurol. 1997 Feb;47(2):120-2; discussion 122-3. doi: 10.1016/s0090-3019(96)00255-8.
PMID: 9040811
citation: Hernandez-Palazon J, Tortosa Serrano JA, Burguillos Lopez S, Molero Molero E. [Infiltration of the surgical wound with local anesthetic for postoperative analgesia in patients operated on for lumbar disc herniation. Comparative study of ropivacaine and bupivacaine]. Rev Esp Anestesiol Reanim. 2001 Jan;48(1):17-20. Spanish.
PMID: 11234601
citation: Gurbet A, Bekar A, Bilgin H, Korfali G, Yilmazlar S, Tercan M. Pre-emptive infiltration of levobupivacaine is superior to at-closure administration in lumbar laminectomy patients. Eur Spine J. 2008 Sep;17(9):1237-41. doi: 10.1007/s00586-008-0676-z. Epub 2008 Apr 19.
PMID: 18425538
citation: Ozyilmaz K, Ayoglu H, Okyay RD, Yurtlu S, Koksal B, Hanci V, Erdogan G, Turan IO. Postoperative analgesic effects of wound infiltration with tramadol and levobupivacaine in lumbar disk surgeries. J Neurosurg Anesthesiol. 2012 Oct;24(4):331-5. doi: 10.1097/ANA.0b013e3182611a1d.
PMID: 22759866
citation: Chae SU, Kim TK, Shim DM, Kim YJ, Choi DH. Is complex regional pain syndrome a cause of post-operative syndrome in the lumbar spine? - a case report -. Asian Spine J. 2009 Dec;3(2):101-5. doi: 10.4184/asj.2009.3.2.101. Epub 2009 Dec 31.
PMID: 20404955
citation: Yalbuzdag SA, Erol AM, Sengul I, Celik C, Solum S, Adilay HU, Gungor B. Temperament and Character Profile in Failed Back Surgery Syndrome: A Cross-Sectional Clinical Study. Turk Neurosurg. 2016;26(6):912-917. doi: 10.5137/1019-5149.JTN.13679-14.0.
PMID: 27476913
citation: Gruenewald M, Herz J, Schoenherr T, Thee C, Steinfath M, Bein B. Measurement of the nociceptive balance by Analgesia Nociception Index and Surgical Pleth Index during sevoflurane-remifentanil anesthesia. Minerva Anestesiol. 2015 May;81(5):480-9. Epub 2014 Jul 17.
PMID: 25032676
responsible party type: Principal Investigator
investigator affiliation: Medical University of Silesia
investigator full name: Michał Stasiowski
investigator title: Principal Investigator, 2Department of Anaesthesiology and Intensive Therapy
mesh term: Dipyrone
mesh term: Tramadol
mesh term: Bupivacaine
mesh term: Ropivacaine
sharing ipd: Yes
ipd description: article in AiIT in 2019,
ipd info type: Informed Consent Form (ICF)