<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/NCT02973581</url>
  </required_header>
  <id_info>
    <org_study_id>SilesianMUKOAiIT2</org_study_id>
    <nct_id>NCT02973581</nct_id>
  </id_info>
  <brief_title>SPI-directed Analgesia for Vitreoretinal Surgeries</brief_title>
  <acronym>SPIVS</acronym>
  <official_title>Influence of Surgical Pleth Index-guided Analgesia Using Different Techniques on the Perioperative Outcomes in Patients Undergoing Vitreoretinal Surgery Under General Anaesthesia: Randomised, Controlled Trial</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 SPI-directed analgesia for&#xD;
      vitreoretinal surgeries (VRS), presence of PONV and oculocardiac reflex (OCR) and compare&#xD;
      Numerical Rating Scale (NRS) with Surgical Pleth Index (SPI) for monitoring pain perception&#xD;
      postoperatively.&#xD;
&#xD;
      Patients received general anaesthesia alone or combined with either preemptive analgesia&#xD;
      using topical solution of 0,5% proxymetacaine or peribulbar block (0,5% bupivacaine with 2%&#xD;
      lidokaine) or preemptive intravenous infusion of 1,0 g of metamizol or preemptive intravenous&#xD;
      infusion of acetaminophen in a doseof 10-15mg/kg of body weight.&#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.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2016</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">February 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>intraoperatively</time_frame>
    <description>The investigators will compare the efficacy of analgesia intraoperatively according to technique of analgesia used preoperatively. The investigators will administer a rescue 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 until SPI value decreases back to baseline value. Additionally, the investigators will analyse rescue fentanyl consumption in abovementioned groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>oculocardiac reflex rate</measure>
    <time_frame>intraoperatively</time_frame>
    <description>The investigators will compare the rate of presence of OCR intraoperatively in studied groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>pain perception postoperatively</measure>
    <time_frame>up to one hour 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 peribulbar block or topical analgesia or intravenous infusion of either metamizol or acetaminophen. The investigators use NRS and compare it with SPI values.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PONV</measure>
    <time_frame>up to one hour</time_frame>
    <description>The investigators will compare the presence of PONV after emergence from GA in studied groups. The investigators will observe patients postoperatively and record any incidence of nausea or vomiting and in the abovementioned case the investigators will administer a standard dose of antiemetic drug.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">176</enrollment>
  <condition>Vitreoretinal Surgeries</condition>
  <condition>Postoperative Nausea and Vomiting</condition>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>metamizol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>analgesic drug</description>
  </arm_group>
  <arm_group>
    <arm_group_label>acetaminophen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>analgesic drug</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0,5 % bupivacaine with of 2% lidocaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>a volume of 5 ml of analgesic solution for regional peribulbar block</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Proxymetacaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>topical analgesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>patients will receive no pre-emptive analgesia. standard doses of fentanyl will be used intraoperatively.</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</description>
    <arm_group_label>acetaminophen</arm_group_label>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>metamizol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetaminophen</intervention_name>
    <description>in group P patients will receive pre-emptive analgesia using intravenous infusion of acetaminophen in a single dose of 10-15 mg per kg of body weight</description>
    <arm_group_label>0,5 % bupivacaine with of 2% lidocaine</arm_group_label>
    <arm_group_label>Proxymetacaine</arm_group_label>
    <arm_group_label>control group</arm_group_label>
    <other_name>paracetamol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0,5 % bupivacaine with of 2% lidocaine</intervention_name>
    <description>in group PBB patients in group BF will receive regional peribulbar block using a solution of 0,5% bupivacaine (2,5 ml) with 2% lidocaine (2,5 ml)</description>
    <arm_group_label>0,5 % bupivacaine with of 2% lidocaine</arm_group_label>
    <arm_group_label>acetaminophen</arm_group_label>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>metamizol</arm_group_label>
    <other_name>Lidocaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Proxymetacaine</intervention_name>
    <description>in group T patients will receive topical analgesia using a solution of 0,5% Alcaine</description>
    <arm_group_label>0,5 % bupivacaine with of 2% lidocaine</arm_group_label>
    <arm_group_label>Proxymetacaine</arm_group_label>
    <arm_group_label>acetaminophen</arm_group_label>
    <arm_group_label>control group</arm_group_label>
    <other_name>Alcaine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  written consent to participate in the study&#xD;
&#xD;
          -  written consent to undergo general anaesthesia alone or combined with different&#xD;
             techniques of pre-emptive analgesia and vitreoretinal surgery&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  history of allergy to local anaesthetics or metamizole&#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>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <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>Mandelcorn M, Taback N, Mandelcorn E, Ananthanarayan C. Risk factors for pain and nausea following retinal and vitreous surgery under conscious sedation. Can J Ophthalmol. 1999 Aug;34(5):281-5.</citation>
    <PMID>10486687</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>
  <results_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>
  </results_reference>
  <results_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>
  </results_reference>
  <results_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>
  </results_reference>
  <results_reference>
    <citation>Jaichandran VV, Raman R, Gella L, Sharma T. Local anesthetic agents for vitreoretinal surgery: no advantage to mixing solutions. Ophthalmology. 2015 May;122(5):1030-3. doi: 10.1016/j.ophtha.2014.11.026. Epub 2015 Jan 10.</citation>
    <PMID>25582785</PMID>
  </results_reference>
  <results_reference>
    <citation>Ghali AM. The efficacy of 0.75% levobupivacaine versus 0.75% ropivacaine for peribulbar anesthesia in vitreoretinal surgery. Saudi J Anaesth. 2012 Jan;6(1):22-6. doi: 10.4103/1658-354X.93050.</citation>
    <PMID>22412772</PMID>
  </results_reference>
  <results_reference>
    <citation>Bahcecioglu H, Unal M, Artunay O, Rasier R, Sarici A. Posterior vitrectomy under topical anesthesia. Can J Ophthalmol. 2007 Apr;42(2):272-7.</citation>
    <PMID>17392852</PMID>
  </results_reference>
  <results_reference>
    <citation>Seidenari P, Santin G, Milani P, David A. Peribulbar and retrobulbar combined anesthesia for vitreoretinal surgery using ropivacaine. Eur J Ophthalmol. 2006 Mar-Apr;16(2):295-9. doi: 10.1177/112067210601600216.</citation>
    <PMID>16703549</PMID>
  </results_reference>
  <results_reference>
    <citation>Eberhart LH, Morin AM, Hoerle S, Wulf H, Geldner G. Droperidol and dolasetron alone or in combination for prevention of postoperative nausea and vomiting after vitrectomy. Ophthalmology. 2004 Aug;111(8):1569-75. doi: 10.1016/j.ophtha.2004.01.031.</citation>
    <PMID>15288990</PMID>
  </results_reference>
  <results_reference>
    <citation>Subramaniam R, Subbarayudu S, Rewari V, Singh RP, Madan R. Usefulness of pre-emptive peribulbar block in pediatric vitreoretinal surgery: a prospective study. Reg Anesth Pain Med. 2003 Jan-Feb;28(1):43-7. doi: 10.1053/rapm.2003.50032.</citation>
    <PMID>12567343</PMID>
  </results_reference>
  <results_reference>
    <citation>Fekrat S, Elsing SH, Raja SC, Campochiaro PA, de Juan E Jr, Haller JA. Eye pain after vitreoretinal surgery: a prospective study of 185 patients. Retina. 2001;21(6):627-32. doi: 10.1097/00006982-200112000-00010.</citation>
    <PMID>11756886</PMID>
  </results_reference>
  <results_reference>
    <citation>Calenda E, Olle P, Muraine M, Brasseur G. Peribulbar anesthesia and sub-Tenon injection for vitreoretinal surgery: 300 cases. Acta Ophthalmol Scand. 2000 Apr;78(2):196-9. doi: 10.1034/j.1600-0420.2000.078002196.x.</citation>
    <PMID>10794256</PMID>
  </results_reference>
  <results_reference>
    <citation>Sajedi P, Nejad MS, Montazeri K, Baloochestani E. Comparing the preventive effect of 2 percent topical lidocaine and intravenous atropine on oculocardiac reflex in ophthalmological surgeries under general anesthesia. Int J Prev Med. 2013 Nov;4(11):1258-65.</citation>
    <PMID>24404359</PMID>
  </results_reference>
  <results_reference>
    <citation>Calenda E, Quintyn JC, Brasseur G. Peribulbar anaesthesia using a combination of lidocaine, bupivocaine and clonidine in vitreoretinal surgery. Indian J Ophthalmol. 2002 Sep;50(3):205-8.</citation>
    <PMID>12355695</PMID>
  </results_reference>
  <results_reference>
    <citation>Page MA, Fraunfelder FW. Safety, efficacy, and patient acceptability of lidocaine hydrochloride ophthalmic gel as a topical ocular anesthetic for use in ophthalmic procedures. Clin Ophthalmol. 2009;3:601-9. doi: 10.2147/opth.s4935. Epub 2009 Nov 2.</citation>
    <PMID>19898665</PMID>
  </results_reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>January 18, 2018</last_update_submitted>
  <last_update_submitted_qc>January 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2018</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, Department 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>Peribulbar Block (PBB)</keyword>
  <keyword>Topical Analgesia (TA)</keyword>
  <keyword>Oculocardiac reflex (OCR)</keyword>
  <keyword>Postoperative nausea nad vomiting (PONV)</keyword>
  <keyword>paracetamol</keyword>
  <keyword>metamizol</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nausea</mesh_term>
    <mesh_term>Vomiting</mesh_term>
    <mesh_term>Postoperative Nausea and Vomiting</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
    <mesh_term>Dipyrone</mesh_term>
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
    <mesh_term>Proxymetacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>article in European Journal of Anaesthesiology in 2018, case reports</ipd_description>
  </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/NCT02973581
org study id: SilesianMUKOAiIT2
nct id: NCT02973581
lead sponsor: 
collaborator: 
has dmc: Yes
The aim of this randomized trial is to assess the efficacy of SPI-directed analgesia for
      vitreoretinal surgeries (VRS), presence of PONV and oculocardiac reflex (OCR) and compare
      Numerical Rating Scale (NRS) with Surgical Pleth Index (SPI) for monitoring pain perception
      postoperatively.

      Patients received general anaesthesia alone or combined with either preemptive analgesia
      using topical solution of 0,5% proxymetacaine or peribulbar block (0,5% bupivacaine with 2%
      lidokaine) or preemptive intravenous infusion of 1,0 g of metamizol or preemptive intravenous
      infusion of acetaminophen in a doseof 10-15mg/kg of body weight.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Participant)
measure: pain perception intraoperatively
time frame: intraoperatively
description: The investigators will compare the efficacy of analgesia intraoperatively according to technique of analgesia used preoperatively. The investigators will administer a rescue 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 until SPI value decreases back to baseline value. Additionally, the investigators will analyse rescue fentanyl consumption in abovementioned groups
measure: oculocardiac reflex rate
time frame: intraoperatively
description: The investigators will compare the rate of presence of OCR intraoperatively in studied groups
measure: pain perception postoperatively
time frame: up to one hour after discharge to postoperative unit.
description: The investigators will compare the efficacy of analgesia postoperatively according to technique of analgesia used preoperatively: either local peribulbar block or topical analgesia or intravenous infusion of either metamizol or acetaminophen. The investigators use NRS and compare it with SPI values.
measure: PONV
time frame: up to one hour
description: The investigators will compare the presence of PONV after emergence from GA in studied groups. The investigators will observe patients postoperatively and record any incidence of nausea or vomiting and in the abovementioned case the investigators will administer a standard dose of antiemetic drug.
arm group label: metamizol
arm group type: Experimental
description: analgesic drug
arm group label: acetaminophen
arm group type: Experimental
description: analgesic drug
arm group label: 0,5 % bupivacaine with of 2% lidocaine
arm group type: Experimental
description: a volume of 5 ml of analgesic solution for regional peribulbar block
arm group label: Proxymetacaine
arm group type: Experimental
description: topical analgesia
arm group label: control group
arm group type: Placebo Comparator
description: patients will receive no pre-emptive analgesia. standard doses of fentanyl will be used intraoperatively.
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
arm group label: acetaminophen
arm group label: control group
arm group label: metamizol
intervention type: Drug
intervention name: Acetaminophen
description: in group P patients will receive pre-emptive analgesia using intravenous infusion of acetaminophen in a single dose of 10-15 mg per kg of body weight
arm group label: 0,5 % bupivacaine with of 2% lidocaine
arm group label: Proxymetacaine
arm group label: control group
other name: paracetamol
intervention type: Drug
intervention name: 0,5 % bupivacaine with of 2% lidocaine
description: in group PBB patients in group BF will receive regional peribulbar block using a solution of 0,5% bupivacaine (2,5 ml) with 2% lidocaine (2,5 ml)
arm group label: 0,5 % bupivacaine with of 2% lidocaine
arm group label: acetaminophen
arm group label: control group
arm group label: metamizol
other name: Lidocaine
intervention type: Drug
intervention name: Proxymetacaine
description: in group T patients will receive topical analgesia using a solution of 0,5% Alcaine
arm group label: 0,5 % bupivacaine with of 2% lidocaine
arm group label: Proxymetacaine
arm group label: acetaminophen
arm group label: control group
other name: Alcaine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
country: Poland
citation: Mandelcorn M, Taback N, Mandelcorn E, Ananthanarayan C. Risk factors for pain and nausea following retinal and vitreous surgery under conscious sedation. Can J Ophthalmol. 1999 Aug;34(5):281-5.
PMID: 10486687
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
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: Jaichandran VV, Raman R, Gella L, Sharma T. Local anesthetic agents for vitreoretinal surgery: no advantage to mixing solutions. Ophthalmology. 2015 May;122(5):1030-3. doi: 10.1016/j.ophtha.2014.11.026. Epub 2015 Jan 10.
PMID: 25582785
citation: Ghali AM. The efficacy of 0.75% levobupivacaine versus 0.75% ropivacaine for peribulbar anesthesia in vitreoretinal surgery. Saudi J Anaesth. 2012 Jan;6(1):22-6. doi: 10.4103/1658-354X.93050.
PMID: 22412772
citation: Bahcecioglu H, Unal M, Artunay O, Rasier R, Sarici A. Posterior vitrectomy under topical anesthesia. Can J Ophthalmol. 2007 Apr;42(2):272-7.
PMID: 17392852
citation: Seidenari P, Santin G, Milani P, David A. Peribulbar and retrobulbar combined anesthesia for vitreoretinal surgery using ropivacaine. Eur J Ophthalmol. 2006 Mar-Apr;16(2):295-9. doi: 10.1177/112067210601600216.
PMID: 16703549
citation: Eberhart LH, Morin AM, Hoerle S, Wulf H, Geldner G. Droperidol and dolasetron alone or in combination for prevention of postoperative nausea and vomiting after vitrectomy. Ophthalmology. 2004 Aug;111(8):1569-75. doi: 10.1016/j.ophtha.2004.01.031.
PMID: 15288990
citation: Subramaniam R, Subbarayudu S, Rewari V, Singh RP, Madan R. Usefulness of pre-emptive peribulbar block in pediatric vitreoretinal surgery: a prospective study. Reg Anesth Pain Med. 2003 Jan-Feb;28(1):43-7. doi: 10.1053/rapm.2003.50032.
PMID: 12567343
citation: Fekrat S, Elsing SH, Raja SC, Campochiaro PA, de Juan E Jr, Haller JA. Eye pain after vitreoretinal surgery: a prospective study of 185 patients. Retina. 2001;21(6):627-32. doi: 10.1097/00006982-200112000-00010.
PMID: 11756886
citation: Calenda E, Olle P, Muraine M, Brasseur G. Peribulbar anesthesia and sub-Tenon injection for vitreoretinal surgery: 300 cases. Acta Ophthalmol Scand. 2000 Apr;78(2):196-9. doi: 10.1034/j.1600-0420.2000.078002196.x.
PMID: 10794256
citation: Sajedi P, Nejad MS, Montazeri K, Baloochestani E. Comparing the preventive effect of 2 percent topical lidocaine and intravenous atropine on oculocardiac reflex in ophthalmological surgeries under general anesthesia. Int J Prev Med. 2013 Nov;4(11):1258-65.
PMID: 24404359
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PMID: 12355695
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PMID: 19898665
responsible party type: Principal Investigator
investigator affiliation: Medical University of Silesia
investigator full name: Michał Stasiowski
investigator title: Principal Investigator, Department of Anaesthesiology and Intensive Therapy
mesh term: Nausea
mesh term: Vomiting
mesh term: Postoperative Nausea and Vomiting
mesh term: Acetaminophen
mesh term: Dipyrone
mesh term: Lidocaine
mesh term: Bupivacaine
mesh term: Proxymetacaine
sharing ipd: Yes
ipd description: article in European Journal of Anaesthesiology in 2018, case reports