<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/NCT04438369</url>
  </required_header>
  <id_info>
    <org_study_id>2018/2239</org_study_id>
    <nct_id>NCT04438369</nct_id>
  </id_info>
  <brief_title>Evaluation of Ultrasound-guided Erector Spinae Block for Postoperative Analgesia in Laprascopic Ventral Hernia Repair.</brief_title>
  <official_title>Evaluation of Ultrasound-guided Erector Spinae Block for Postoperative Analgesia in Laprascopic Ventral Hernia Repair.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ostfold Hospital Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ostfold Hospital Trust</source>
  <oversight_info>
    <has_dmc>No</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>
      Ventral hernia repair is associated with significant postoperative pain, and regional&#xD;
      anesthetic techniques are of potential benefit.&#xD;
&#xD;
      The postoperative mobility and training is of utmost importance in this patient group, and&#xD;
      could be increased using local anesthetics instead of opioids.&#xD;
&#xD;
      Inadequate post-operative pain control can lead to adverse consequences for patients, such as&#xD;
      the development of chronic pain, immunosuppression, poorer healing of surgical wounds, as&#xD;
      well as adrenergic activation and its consequences in the form of coronary incidents or&#xD;
      gastrointestinal obstruction and postoperative nausea and vomiting (PONV). Moreover, lack of&#xD;
      mobility can result in thrombosis and embolism. These complications affect hospital&#xD;
      functioning, which leads to decreased patient satisfaction, a worse reputation for the&#xD;
      hospital, longer stays in the recovery room, prolonged hospitalizations, higher incidence of&#xD;
      re-surgeries and re-admissions, and higher costs for care and treatment.&#xD;
&#xD;
      Erector spinae plane block (ESPB) is the latest of the truncal blocks and was first described&#xD;
      in 2016. The efficacy of bilateral ESPB at the T7 level has been described in a study of 4&#xD;
      cases, moreover effective analgesia with ESPB after bariatric surgery has been described in a&#xD;
      study of 3 cases. When performed at the level of the T7 transverse process, studies show the&#xD;
      potential to block both supra-umbilical and infra-umbilical dermatomes. So far there are&#xD;
      mostly case studies done in this field of study, and internationally there is a call for&#xD;
      research into the effect of this technique and randomized controlled trials.&#xD;
&#xD;
      The objective of this study is to compare ESPB to multimodal analgesia in patients undergoing&#xD;
      ventral hernia repair.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypothesis, aims and objectives&#xD;
&#xD;
      The postulated nullhypothesis and alternativ hypothesis is:&#xD;
&#xD;
      H0= there is no difference in opioid consumption postoperatively between multimodal analgesia&#xD;
      and ESPB. HA= there is a reduction in opioid consumption postoperatively between standard&#xD;
      multimodal analgesia and ESPB.&#xD;
&#xD;
      Sample size calculation&#xD;
&#xD;
      Sample size estimation was calculated from our series of 20 pilot-patients on ventral hernia&#xD;
      surgery without block, who needed on average 24.6 mg oral morphine equivalents (OME) iv&#xD;
      oxycodone rescue analgesia during the first hour, SD=17.35 mg. Assuming a one sided study and&#xD;
      in order to show a 50% reduction in rescue opioid consumption after a successful block with&#xD;
      80% power and 0.05 as level of significance, at least 2 x 26 patients should be studied,&#xD;
      total of 52 patients. In order to adjust for missing data and protocol violations we decided&#xD;
      to include 2 x 30 patients in our study.&#xD;
&#xD;
      This is a study where all parties are blinded for the allocation. A study nurse draws up the&#xD;
      allocated study medication in an unmarked syringe so that the anesthesiologist is blinded.&#xD;
      The study nurse responsible for the medication is not the same nurse that does the&#xD;
      postoperative scoring. The study nurse responsible for the medication puts masked containers&#xD;
      of the allocated medication into opaque envelopes and delivers the envelope to the ward. The&#xD;
      ward personnel will then be masked for the allocation. The study nurse responsible for the&#xD;
      follow up calls are not the same study nurse responsible for the medications and as such is&#xD;
      also blinded for the allocation.&#xD;
&#xD;
      The primary outcome measure is the opiate consumption measured in oral morphine equivalents&#xD;
      after 1 hour.&#xD;
&#xD;
      Secondary outcome measures are;&#xD;
&#xD;
        -  Opiate consummation after 4 hours, 24 hours, 48 hours and 7 days. As patients receive&#xD;
           different types of opiates, opiate consumption will be measured as oral morphine&#xD;
           equivalents for ease of comparison. Oksykodon iv is converted by a factor of 1:1,5 to&#xD;
           oral morphine.&#xD;
&#xD;
        -  Time to first mobilization&#xD;
&#xD;
        -  Time to first analgesic requirement&#xD;
&#xD;
        -  Pain measuring tool used in this project is the validated numerical rating scale (NRS),&#xD;
           which is a 11- point scale from 0-10, where no pain is NRS=0, mild pain is NRS 1-3,&#xD;
           moderate pain NRS 4-6 and severe pain 7-10. NRS will be measured at rest and with&#xD;
           activity at the time points 1, 2 and 3 hours.&#xD;
&#xD;
        -  Sedation is measured by the validated Pasero opioid-induced sedation scale (POSS). The&#xD;
           POSS measures normal sleep as S and then the degree of sedation on a numerical scale&#xD;
           from 1-4. Will be measured at 1, 2 and 3 hours.&#xD;
&#xD;
        -  Nausea and vomiting is measured by the validated PONV impact scale. This is a tool that&#xD;
           entails two questions about nausea and vomiting, and each question gets rated on a&#xD;
           numeric scale from 0-4. Will be measured at 1, 2 and 3 hours.&#xD;
&#xD;
      After the operation the patients will be asked to answer the QoR-15, which consist of 15&#xD;
      questions distributed on two dimensions: &quot;physical&quot; and &quot;mental&quot; well-being, where the&#xD;
      patients report their experiences on a scale from 0 (=not at all) to 10 (=all the time). As a&#xD;
      complementing measure to the QoR-15 the patients will also be asked the EQ-5D questionnaire.&#xD;
      The EQ-5D questionnaire is an outcome measure of patient health after operation. The EQ-5D-5L&#xD;
      is comprised of two different measures; the EQ-5D descriptive system and the EQ visual&#xD;
      analogue scale (EQ VAS). Both QoR-15 and EQ-5D will be measured at 48 hours and 7 days.&#xD;
&#xD;
      The objective is to gain knowledge to support anesthesiologists when deciding analgesic&#xD;
      approach, as well as in shared decision-making with patients (including the patient&#xD;
      perspective). All results are expected to be presented during the project period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2023</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>
    <intervention_model_description>The study is planned as a randomized controlled trial (RCT) with two study arms. One arm is the intervention arm, who will receive the active treatment. The other arm is the control arm, who will receive a placebo treatment.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>The randomization was done through a computer-generated block randomization process (randomization.com) to reduce bias. The block sizes were randomly chosen to 2, 4 and 6. The total patients randomized were 60 patients to account for missing data and protocol violations. A study nurse prepared and placed the notes of study allocation covered with aluminum foil into opaque envelopes. The envelopes were numbered from 1- 60.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Opiat consumption</measure>
    <time_frame>Postoperatively at one hour.</time_frame>
    <description>The opioid consumption measured in orale morphine equivalents after one hour postoperatively.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postopertive nausea</measure>
    <time_frame>Postoperatively at 0-4 hours, 4-24 hours, 24-48 hours and 48 hours-7 days.</time_frame>
    <description>We will measure postoperative nausea with the Postoperative nausea and vomiting (PONV) impact scale. This is a tool that entails two questions about nausea and vomiting, and each question gets rated on a numeric scale from 0-4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative sedation</measure>
    <time_frame>Postoperatively at 0-4 hours, 4-24 hours, 24-48 hours and 48 hours-7 days.</time_frame>
    <description>We will measure postoperative sedation with the Pasero opioid-induced sedation scale (POSS). The POSS measures normal sleep as S and then the degree of sedation on a numerical scale from 1-4. Will be measured at 1, 2 and 3 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>Postoperatively at 1-4 hours, 4-24 hours, 24-48 hours and 48 hours-7 days.</time_frame>
    <description>We will measure postoperative pain with postoperative Numeric Rating Scale (NRS). A scale from 0-10 where 0 is no pain and 10 is worst pain imaginable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of recovery 15</measure>
    <time_frame>24 hours, 48 hours and 7 days.</time_frame>
    <description>We will measure the patients quality of recovery with the validated QoR-15 questionaire. This will be done via telephone interviews.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Ventral Hernia</condition>
  <condition>Postoperative Pain</condition>
  <condition>Regional Anesthesia</condition>
  <arm_group>
    <arm_group_label>Erector spinae block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group ESPB: Multimodal analgesia comprising of preoperative paracetamol adjusted for weight (2000 milligrams (mg) &gt;70 kilograms (kg) &lt;70 years, 1500 mg &lt;70 kg &gt;70 years, 1000 mg &lt;50 kg) and diclofenac adjusted for weight (100 mg &gt;70 kg &lt;70 years, 50 mg &lt;70 kg &gt;70 years). After the operation they receive paracetamol 1000 mg x4 and diclofenac 50 mg x3 a day, as well as PCA with iv oxycodon 1 mg/ml.&#xD;
Preoperatively positioned bilateral catheters at level T7 injected with ropivacaine 2,5 mg/ml, 30 ml on each side. Postoperative maintenance treatment with injection of 2 mg/ml ropivacaine 30 ml on each side every 6 hours postoperatively. Maximum allowed bolus preoperative ropivacaine dose is 3 mg/kg body weight (BW), while the maximum 24 hour dose postoperatively is 11 mg/kg to avoid local anesthesia systemic toxicity (LAST). The catheter will be discontinued 24 hours after the original procedure. The container with ropivacaine will be masked for blinding of the personnel on the ward.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Control group with standard multimodal analgesia: Preoperative paracetamol adjusted for weight (2000 milligrams (mg) &gt;70 kilograms (kg) &lt;70 years, 1500 mg &lt;70 kg &gt;70 years, 1000 mg &lt;50 kg) and diclofenac adjusted for weight (100 mg &gt;70 kg &lt;70 years, 50 mg &lt;70 kg &gt;70 years). After the operation they receive paracetamol 1000 mg x4 and diclofenac 50 mg x3 a day, as well as PCA with iv oxycodone 1 mg/ml.&#xD;
Insertion of bilateral catheters preoperatively. Injection of 30 ml saline preoperatively and every 6 hours postoperatively. The catheter will be discontinued 24 hours after the original procedure. The container with saline will be masked for blinding of the personnel on the ward.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Erector Spinae Plane Block</intervention_name>
    <description>Cathether based Erector Spinae Plane Block for postoperative pain management.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Erector spinae block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        The inclusion criteria:&#xD;
&#xD;
          -  Age &gt;18&#xD;
&#xD;
          -  BMI (body mass index) 18,5 - 40 and weight &gt;65 kg&#xD;
&#xD;
          -  ASA (American Association of Anesthesiologists Classification system for physical&#xD;
             status) I-III .&#xD;
&#xD;
          -  Scheduled for elective ventral hernia operation&#xD;
&#xD;
          -  Planned hospital stay &gt;24 hrs&#xD;
&#xD;
        The exclusion criteria;&#xD;
&#xD;
          -  Allergy to latex, local anesthesia, Non-Steroidal Anti-Inflammatory Drugs or opioids&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Chronic pain with daily opiate use&#xD;
&#xD;
          -  Patients with severe renal and/or hepatic disease&#xD;
&#xD;
          -  Local infection at the site of injection&#xD;
&#xD;
          -  Systemic infection&#xD;
&#xD;
          -  AV block 2-3&#xD;
&#xD;
          -  Inability to understand written or spoken Norwegian&#xD;
&#xD;
          -  Inability to cooperate&#xD;
&#xD;
          -  Dementia&#xD;
&#xD;
          -  Known abuse of alcohol or medication&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Weight under 65 kg&#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>Marie Soerenstua, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sykehuset Ostfold HF</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marie Soerenstua, MD</last_name>
    <phone>+4790768830</phone>
    <email>marie.sorenstua@so-hf.no</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ann-Chatrin Leonardsen, PhD</last_name>
    <phone>+4741668797</phone>
    <email>ann-cathrin.linqvist.leonardsen@so-hf.no</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ostfold Hospital Trust, Moss</name>
      <address>
        <city>Moss</city>
        <state>Ostfold</state>
        <zip>1535</zip>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marie Soerenstua, MD</last_name>
      <phone>+4790768830</phone>
      <email>mbergemohr@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Marie Soerenstua, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Annelene Skaug, Nurse</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Knut Inge Solbakk, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>April 27, 2023</last_update_submitted>
  <last_update_submitted_qc>April 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Erector Spinae Plane Block</keyword>
  <keyword>Postoperative pain</keyword>
  <keyword>Ventral hernia repair</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Hernia, Ventral</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD will be available upon request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>At publication date and for three months.</ipd_time_frame>
  </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/NCT04438369
org study id: 2018/2239
nct id: NCT04438369
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Ventral hernia repair is associated with significant postoperative pain, and regional
      anesthetic techniques are of potential benefit.

      The postoperative mobility and training is of utmost importance in this patient group, and
      could be increased using local anesthetics instead of opioids.

      Inadequate post-operative pain control can lead to adverse consequences for patients, such as
      the development of chronic pain, immunosuppression, poorer healing of surgical wounds, as
      well as adrenergic activation and its consequences in the form of coronary incidents or
      gastrointestinal obstruction and postoperative nausea and vomiting (PONV). Moreover, lack of
      mobility can result in thrombosis and embolism. These complications affect hospital
      functioning, which leads to decreased patient satisfaction, a worse reputation for the
      hospital, longer stays in the recovery room, prolonged hospitalizations, higher incidence of
      re-surgeries and re-admissions, and higher costs for care and treatment.

      Erector spinae plane block (ESPB) is the latest of the truncal blocks and was first described
      in 2016. The efficacy of bilateral ESPB at the T7 level has been described in a study of 4
      cases, moreover effective analgesia with ESPB after bariatric surgery has been described in a
      study of 3 cases. When performed at the level of the T7 transverse process, studies show the
      potential to block both supra-umbilical and infra-umbilical dermatomes. So far there are
      mostly case studies done in this field of study, and internationally there is a call for
      research into the effect of this technique and randomized controlled trials.

      The objective of this study is to compare ESPB to multimodal analgesia in patients undergoing
      ventral hernia repair.
Hypothesis, aims and objectives

      The postulated nullhypothesis and alternativ hypothesis is:

      H0= there is no difference in opioid consumption postoperatively between multimodal analgesia
      and ESPB. HA= there is a reduction in opioid consumption postoperatively between standard
      multimodal analgesia and ESPB.

      Sample size calculation

      Sample size estimation was calculated from our series of 20 pilot-patients on ventral hernia
      surgery without block, who needed on average 24.6 mg oral morphine equivalents (OME) iv
      oxycodone rescue analgesia during the first hour, SD=17.35 mg. Assuming a one sided study and
      in order to show a 50% reduction in rescue opioid consumption after a successful block with
      80% power and 0.05 as level of significance, at least 2 x 26 patients should be studied,
      total of 52 patients. In order to adjust for missing data and protocol violations we decided
      to include 2 x 30 patients in our study.

      This is a study where all parties are blinded for the allocation. A study nurse draws up the
      allocated study medication in an unmarked syringe so that the anesthesiologist is blinded.
      The study nurse responsible for the medication is not the same nurse that does the
      postoperative scoring. The study nurse responsible for the medication puts masked containers
      of the allocated medication into opaque envelopes and delivers the envelope to the ward. The
      ward personnel will then be masked for the allocation. The study nurse responsible for the
      follow up calls are not the same study nurse responsible for the medications and as such is
      also blinded for the allocation.

      The primary outcome measure is the opiate consumption measured in oral morphine equivalents
      after 1 hour.

      Secondary outcome measures are;

        -  Opiate consummation after 4 hours, 24 hours, 48 hours and 7 days. As patients receive
           different types of opiates, opiate consumption will be measured as oral morphine
           equivalents for ease of comparison. Oksykodon iv is converted by a factor of 1:1,5 to
           oral morphine.

        -  Time to first mobilization

        -  Time to first analgesic requirement

        -  Pain measuring tool used in this project is the validated numerical rating scale (NRS),
           which is a 11- point scale from 0-10, where no pain is NRS=0, mild pain is NRS 1-3,
           moderate pain NRS 4-6 and severe pain 7-10. NRS will be measured at rest and with
           activity at the time points 1, 2 and 3 hours.

        -  Sedation is measured by the validated Pasero opioid-induced sedation scale (POSS). The
           POSS measures normal sleep as S and then the degree of sedation on a numerical scale
           from 1-4. Will be measured at 1, 2 and 3 hours.

        -  Nausea and vomiting is measured by the validated PONV impact scale. This is a tool that
           entails two questions about nausea and vomiting, and each question gets rated on a
           numeric scale from 0-4. Will be measured at 1, 2 and 3 hours.

      After the operation the patients will be asked to answer the QoR-15, which consist of 15
      questions distributed on two dimensions: "physical" and "mental" well-being, where the
      patients report their experiences on a scale from 0 (=not at all) to 10 (=all the time). As a
      complementing measure to the QoR-15 the patients will also be asked the EQ-5D questionnaire.
      The EQ-5D questionnaire is an outcome measure of patient health after operation. The EQ-5D-5L
      is comprised of two different measures; the EQ-5D descriptive system and the EQ visual
      analogue scale (EQ VAS). Both QoR-15 and EQ-5D will be measured at 48 hours and 7 days.

      The objective is to gain knowledge to support anesthesiologists when deciding analgesic
      approach, as well as in shared decision-making with patients (including the patient
      perspective). All results are expected to be presented during the project period.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The study is planned as a randomized controlled trial (RCT) with two study arms. One arm is the intervention arm, who will receive the active treatment. The other arm is the control arm, who will receive a placebo treatment.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: The randomization was done through a computer-generated block randomization process (randomization.com) to reduce bias. The block sizes were randomly chosen to 2, 4 and 6. The total patients randomized were 60 patients to account for missing data and protocol violations. A study nurse prepared and placed the notes of study allocation covered with aluminum foil into opaque envelopes. The envelopes were numbered from 1- 60.
measure: Opiat consumption
time frame: Postoperatively at one hour.
description: The opioid consumption measured in orale morphine equivalents after one hour postoperatively.
measure: Postopertive nausea
time frame: Postoperatively at 0-4 hours, 4-24 hours, 24-48 hours and 48 hours-7 days.
description: We will measure postoperative nausea with the Postoperative nausea and vomiting (PONV) impact scale. This is a tool that entails two questions about nausea and vomiting, and each question gets rated on a numeric scale from 0-4.
measure: Postoperative sedation
time frame: Postoperatively at 0-4 hours, 4-24 hours, 24-48 hours and 48 hours-7 days.
description: We will measure postoperative sedation with the Pasero opioid-induced sedation scale (POSS). The POSS measures normal sleep as S and then the degree of sedation on a numerical scale from 1-4. Will be measured at 1, 2 and 3 hours.
measure: Postoperative pain
time frame: Postoperatively at 1-4 hours, 4-24 hours, 24-48 hours and 48 hours-7 days.
description: We will measure postoperative pain with postoperative Numeric Rating Scale (NRS). A scale from 0-10 where 0 is no pain and 10 is worst pain imaginable.
measure: Quality of recovery 15
time frame: 24 hours, 48 hours and 7 days.
description: We will measure the patients quality of recovery with the validated QoR-15 questionaire. This will be done via telephone interviews.
arm group label: Erector spinae block
arm group type: Active Comparator
description: Group ESPB: Multimodal analgesia comprising of preoperative paracetamol adjusted for weight (2000 milligrams (mg) >70 kilograms (kg) <70 years, 1500 mg <70 kg >70 years, 1000 mg <50 kg) and diclofenac adjusted for weight (100 mg >70 kg <70 years, 50 mg <70 kg >70 years). After the operation they receive paracetamol 1000 mg x4 and diclofenac 50 mg x3 a day, as well as PCA with iv oxycodon 1 mg/ml.
Preoperatively positioned bilateral catheters at level T7 injected with ropivacaine 2,5 mg/ml, 30 ml on each side. Postoperative maintenance treatment with injection of 2 mg/ml ropivacaine 30 ml on each side every 6 hours postoperatively. Maximum allowed bolus preoperative ropivacaine dose is 3 mg/kg body weight (BW), while the maximum 24 hour dose postoperatively is 11 mg/kg to avoid local anesthesia systemic toxicity (LAST). The catheter will be discontinued 24 hours after the original procedure. The container with ropivacaine will be masked for blinding of the personnel on the ward.
arm group label: Control
arm group type: Placebo Comparator
description: Control group with standard multimodal analgesia: Preoperative paracetamol adjusted for weight (2000 milligrams (mg) >70 kilograms (kg) <70 years, 1500 mg <70 kg >70 years, 1000 mg <50 kg) and diclofenac adjusted for weight (100 mg >70 kg <70 years, 50 mg <70 kg >70 years). After the operation they receive paracetamol 1000 mg x4 and diclofenac 50 mg x3 a day, as well as PCA with iv oxycodone 1 mg/ml.
Insertion of bilateral catheters preoperatively. Injection of 30 ml saline preoperatively and every 6 hours postoperatively. The catheter will be discontinued 24 hours after the original procedure. The container with saline will be masked for blinding of the personnel on the ward.
intervention type: Procedure
intervention name: Erector Spinae Plane Block
description: Cathether based Erector Spinae Plane Block for postoperative pain management.
arm group label: Control
arm group label: Erector spinae block
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marie Soerenstua, MD
role: Principal Investigator
affiliation: Sykehuset Ostfold HF
last name: Marie Soerenstua, MD
phone: +4790768830
email: marie.sorenstua@so-hf.no
last name: Ann-Chatrin Leonardsen, PhD
phone: +4741668797
email: ann-cathrin.linqvist.leonardsen@so-hf.no
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: Norway
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Hernia
mesh term: Hernia, Ventral
sharing ipd: Yes
ipd description: IPD will be available upon request.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: At publication date and for three months.