<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/NCT03300089</url>
  </required_header>
  <id_info>
    <org_study_id>EKNZ 2015-261</org_study_id>
    <nct_id>NCT03300089</nct_id>
  </id_info>
  <brief_title>Lumbar Spine Surgery: Regional vs. General Anaesthesia</brief_title>
  <official_title>Effect of Anaesthetic Techniques on Clinical Outcome After Lumbar Spine Surgery: Regional Versus General Anaesthesia. A Prospective Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Anna Clinic Luzern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Anna Clinic Luzern</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Lumbar spine surgery can be performed using different anaesthetic techniques such&#xD;
      as general endotracheal anaesthesia (GA) or spinal-based regional anaesthesia (RA), that have&#xD;
      different side effect profiles (e.g. opioids - nausea, vomiting, pruritus, sedation; local&#xD;
      anaesthetics - motor weakness) which may affect quality of recovery in different ways.&#xD;
&#xD;
      Aim of the study: The purpose of this study is to determine the effects of GA and RA in&#xD;
      lumbar spine surgery on clinical outcome, combining validated patient-reporting instruments&#xD;
      and morbidity such as serious adverse events.&#xD;
&#xD;
      Hypothesis: The investigators hypothesize that in patients undergoing lumbar spine surgery,&#xD;
      RA shows significant advantages as compared to GA with respect to the postoperative pain&#xD;
      score, the degree of postoperative nausea and vomiting (PONV), the postoperative anaesthetic&#xD;
      care unit (PACU) and anaesthesia time and the satisfaction of patients and surgeons.&#xD;
&#xD;
      Design of the study: This is a single-centre two-arm randomised-controlled trail.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Background Lumbar spine surgery can be performed using different anaesthetic techniques&#xD;
           such as general endotracheal anaesthesia (GA) or spinal-based regional anaesthesia (RA).&#xD;
           In a recent review several studies showed a decreased postoperative pain score in the RA&#xD;
           groups (1). But only few randomized control trials (RCT) have been performed comparing&#xD;
           these two anaesthetic techniques and have shown partly conflicting results (2-5).&#xD;
&#xD;
           Each anaesthetic agent or regimen has a particular side effect profile (e.g. opioids -&#xD;
           nausea, vomiting, pruritus, sedation; local anaesthetics - motor weakness) which may&#xD;
           affect quality of recovery in different ways. Although there are few data examining the&#xD;
           correlation between side effects from different analgesic regimens and quality of&#xD;
           recovery per se, some data suggest different analgesic regimens will result in different&#xD;
           side effects and consequently different levels of quality of recovery.&#xD;
&#xD;
           Although inconsistent data exist covering surgery time, anaesthesia time, postoperative&#xD;
           anaesthetic care unit (PACU) time and postoperative analgesic dose requirements (6-8).&#xD;
&#xD;
           But there are some hinds that RA leads to better results concerning postoperative&#xD;
           mortality and morbidity in opposite to general anaesthesia (9-10). Also RA showed better&#xD;
           results concerning economic aspects (11,12).&#xD;
&#xD;
           No clinical trials have sufficient subject numbers to determine definitively the effects&#xD;
           of anaesthetic techniques on minor or major benefits concerning clinical outcome. There&#xD;
           is insufficient evidence to confirm or deny the ability of these two anaesthetic&#xD;
           techniques to affect major postoperative mortality or morbidity and there is currently&#xD;
           no sufficient evidence that RA or GA have any clinically significant beneficial effect&#xD;
           on postoperative outcome. Further there are still insufficient data to determine if the&#xD;
           type of anaesthetic technique, degree of analgesia and the presence of side effects may&#xD;
           influence quality of life, quality of recovery, patient and surgeon's satisfaction and&#xD;
           length of hospitalisation.&#xD;
&#xD;
           There are few data examining the correlation between side effects from different&#xD;
           anaesthetic regimens and quality of recovery per se, some data suggest different&#xD;
           analgesic regimens may result in different side effects and consequently different&#xD;
           levels of quality of recovery.&#xD;
&#xD;
           Although there are data suggesting that improved postoperative analgesia leads to better&#xD;
           patient outcomes, there is insufficient evidence to support subsequent improvements&#xD;
           inpatient-centered outcomes such as quality of life and quality of recovery. So the&#xD;
           correlation between RA and different outcome parameters are very complex and up to now&#xD;
           there is no clear evidence for any recommendation concerning the use of RA or GA in&#xD;
           generally (13).&#xD;
&#xD;
        2. Study Objective Lumbar spine surgery can be performed using different anaesthetic&#xD;
           techniques such as general endotracheal anaesthesia (GA) or spinal-based regional&#xD;
           anaesthesia (RA). The purpose of this study is to determine the effects of two different&#xD;
           anaesthetic techniques and their impact on clinical outcome.&#xD;
&#xD;
           Further this study is developed to combine validated patient-reported instruments with&#xD;
           the assessment of the effect of different anaesthetic techniques on patient-reported&#xD;
           outcomes in the peri-and postoperative period.&#xD;
&#xD;
        3. Hypothesis The investigators hypothesize that for patients undergoing lumbar spine&#xD;
           surgery, the performing of a RA shows significant benefits in comparison with patients&#xD;
           receiving GA. It concerns the postoperative pain score, the degree of PONV, the PACU and&#xD;
           anaesthesia time and the patient's and surgeons's satisfaction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 19, 2016</start_date>
  <completion_date type="Actual">July 20, 2017</completion_date>
  <primary_completion_date type="Actual">May 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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Outcomes Assessor and statistician are blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Morphine consumption</measure>
    <time_frame>From immediately after the operation until 48 hours postoperative</time_frame>
    <description>Cumulated morphine consumption in mg</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>VAS score</measure>
    <time_frame>Postoperative at the day of surgery until 48 hours postoperative</time_frame>
    <description>Visual Analog Pain assessment, assessed each day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anesthesia time</measure>
    <time_frame>Day of surgery</time_frame>
    <description>Duration of anesthesia in minutes</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Herniated Disk Lumbar</condition>
  <arm_group>
    <arm_group_label>General Anaesthesia</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>General Anaesthesia during surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Regional Anaesthesia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Regional Anaesthesia during surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>General anaesthesia</intervention_name>
    <description>General anaesthesia</description>
    <arm_group_label>General Anaesthesia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Regional anaesthesia</intervention_name>
    <description>Regional anaesthesia</description>
    <arm_group_label>Regional Anaesthesia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient must give informed consent before registration.&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Physical Status Classification of the American Society of Anaesthesiologists Score&#xD;
             (ASA) ≤ 3&#xD;
&#xD;
          -  Patient with a diagnosed lumbar spinal stenosis or a herniated lumbar disc for&#xD;
             elective neurosurgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA ≥ 4&#xD;
&#xD;
          -  Infection at the site of the operation field&#xD;
&#xD;
          -  Longterm History (≥ 6 month) of neuropathic pain on the operation site&#xD;
&#xD;
          -  Revision surgery and/or follow-up operations&#xD;
&#xD;
          -  Severe coagulopathy (platelet count &lt; 100.000 / mL3 or Thromboplastin time &lt; 50%)&#xD;
&#xD;
          -  Allergy to local anaesthetics or opioids&#xD;
&#xD;
          -  Previous drug dependency or chronic use of opioids (≥ 6 month)&#xD;
&#xD;
          -  Psychiatric disorder precluding understanding of information on trial related topics&#xD;
             or given informant consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bertram Bänziger, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klinik St. Anna Luzern</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Anna Hospital</name>
      <address>
        <city>Luzern</city>
        <zip>CH - 6006</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>De Rojas JO, Syre P, Welch WC. Regional anesthesia versus general anesthesia for surgery on the lumbar spine: a review of the modern literature. Clin Neurol Neurosurg. 2014 Apr;119:39-43. doi: 10.1016/j.clineuro.2014.01.016. Epub 2014 Jan 27.</citation>
    <PMID>24635923</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>September 27, 2017</last_update_submitted>
  <last_update_submitted_qc>September 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intervertebral Disc Displacement</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03300089
org study id: EKNZ 2015-261
nct id: NCT03300089
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Background: Lumbar spine surgery can be performed using different anaesthetic techniques such
      as general endotracheal anaesthesia (GA) or spinal-based regional anaesthesia (RA), that have
      different side effect profiles (e.g. opioids - nausea, vomiting, pruritus, sedation; local
      anaesthetics - motor weakness) which may affect quality of recovery in different ways.

      Aim of the study: The purpose of this study is to determine the effects of GA and RA in
      lumbar spine surgery on clinical outcome, combining validated patient-reporting instruments
      and morbidity such as serious adverse events.

      Hypothesis: The investigators hypothesize that in patients undergoing lumbar spine surgery,
      RA shows significant advantages as compared to GA with respect to the postoperative pain
      score, the degree of postoperative nausea and vomiting (PONV), the postoperative anaesthetic
      care unit (PACU) and anaesthesia time and the satisfaction of patients and surgeons.

      Design of the study: This is a single-centre two-arm randomised-controlled trail.
1. Background Lumbar spine surgery can be performed using different anaesthetic techniques
           such as general endotracheal anaesthesia (GA) or spinal-based regional anaesthesia (RA).
           In a recent review several studies showed a decreased postoperative pain score in the RA
           groups (1). But only few randomized control trials (RCT) have been performed comparing
           these two anaesthetic techniques and have shown partly conflicting results (2-5).

           Each anaesthetic agent or regimen has a particular side effect profile (e.g. opioids -
           nausea, vomiting, pruritus, sedation; local anaesthetics - motor weakness) which may
           affect quality of recovery in different ways. Although there are few data examining the
           correlation between side effects from different analgesic regimens and quality of
           recovery per se, some data suggest different analgesic regimens will result in different
           side effects and consequently different levels of quality of recovery.

           Although inconsistent data exist covering surgery time, anaesthesia time, postoperative
           anaesthetic care unit (PACU) time and postoperative analgesic dose requirements (6-8).

           But there are some hinds that RA leads to better results concerning postoperative
           mortality and morbidity in opposite to general anaesthesia (9-10). Also RA showed better
           results concerning economic aspects (11,12).

           No clinical trials have sufficient subject numbers to determine definitively the effects
           of anaesthetic techniques on minor or major benefits concerning clinical outcome. There
           is insufficient evidence to confirm or deny the ability of these two anaesthetic
           techniques to affect major postoperative mortality or morbidity and there is currently
           no sufficient evidence that RA or GA have any clinically significant beneficial effect
           on postoperative outcome. Further there are still insufficient data to determine if the
           type of anaesthetic technique, degree of analgesia and the presence of side effects may
           influence quality of life, quality of recovery, patient and surgeon's satisfaction and
           length of hospitalisation.

           There are few data examining the correlation between side effects from different
           anaesthetic regimens and quality of recovery per se, some data suggest different
           analgesic regimens may result in different side effects and consequently different
           levels of quality of recovery.

           Although there are data suggesting that improved postoperative analgesia leads to better
           patient outcomes, there is insufficient evidence to support subsequent improvements
           inpatient-centered outcomes such as quality of life and quality of recovery. So the
           correlation between RA and different outcome parameters are very complex and up to now
           there is no clear evidence for any recommendation concerning the use of RA or GA in
           generally (13).

        2. Study Objective Lumbar spine surgery can be performed using different anaesthetic
           techniques such as general endotracheal anaesthesia (GA) or spinal-based regional
           anaesthesia (RA). The purpose of this study is to determine the effects of two different
           anaesthetic techniques and their impact on clinical outcome.

           Further this study is developed to combine validated patient-reported instruments with
           the assessment of the effect of different anaesthetic techniques on patient-reported
           outcomes in the peri-and postoperative period.

        3. Hypothesis The investigators hypothesize that for patients undergoing lumbar spine
           surgery, the performing of a RA shows significant benefits in comparison with patients
           receiving GA. It concerns the postoperative pain score, the degree of PONV, the PACU and
           anaesthesia time and the patient's and surgeons's satisfaction.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Outcomes Assessor and statistician are blinded.
measure: Morphine consumption
time frame: From immediately after the operation until 48 hours postoperative
description: Cumulated morphine consumption in mg
measure: VAS score
time frame: Postoperative at the day of surgery until 48 hours postoperative
description: Visual Analog Pain assessment, assessed each day
measure: Anesthesia time
time frame: Day of surgery
description: Duration of anesthesia in minutes
arm group label: General Anaesthesia
arm group type: Active Comparator
description: General Anaesthesia during surgery
arm group label: Regional Anaesthesia
arm group type: Experimental
description: Regional Anaesthesia during surgery
intervention type: Procedure
intervention name: General anaesthesia
description: General anaesthesia
arm group label: General Anaesthesia
intervention type: Procedure
intervention name: Regional anaesthesia
description: Regional anaesthesia
arm group label: Regional Anaesthesia
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bertram Bänziger, MD
role: Principal Investigator
affiliation: Klinik St. Anna Luzern
facility: 
country: Switzerland
citation: De Rojas JO, Syre P, Welch WC. Regional anesthesia versus general anesthesia for surgery on the lumbar spine: a review of the modern literature. Clin Neurol Neurosurg. 2014 Apr;119:39-43. doi: 10.1016/j.clineuro.2014.01.016. Epub 2014 Jan 27.
PMID: 24635923
responsible party type: Sponsor
mesh term: Intervertebral Disc Displacement
mesh term: Anesthetics
sharing ipd: Undecided