<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/NCT03267628</url>
  </required_header>
  <id_info>
    <org_study_id>HREC/17/QPCH/121</org_study_id>
    <nct_id>NCT03267628</nct_id>
  </id_info>
  <brief_title>Comparison of Intrathecal Morphine With the Quadratus Lumborum Type 2 Block for Post-operative Analgesia Following Elective Caesarean Section (QLBvITM Study)</brief_title>
  <official_title>Quadratus Lumborum Type 2 Block Versus Intrathecal Morphine for Analgesia Following Elective Caesarean Sections</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr Willem Basson</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sunshine Coast Hospital and Health Service</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sunshine Coast Hospital and Health Service</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>
      The investigators are comparing post operative analgesia provided for caesarean section&#xD;
      patients, with the quadratus lumborum type 2 block and intrathecal morphine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In Australia the rate of birth via caesarean section (CS) has significantly increased over&#xD;
      the last twenty years. Improvements in the care of women undergoing CS are important locally,&#xD;
      nationally and internationally. Compared to women birthing vaginally, women undergoing CS&#xD;
      experience more adverse events and more pain. Effective pain relief following CS is important&#xD;
      as it enables early ambulation, encourages maternal bonding, and promotes breastfeeding&#xD;
      initiation and establishment. Traditional analgesic techniques following CS include opioid&#xD;
      medications. Whist effective, the use of opioids are associated with frequent and significant&#xD;
      side effects. Alternative analgesic agents are being explored in an attempt to improve the&#xD;
      effectiveness of pain relief available to women and clinicians.&#xD;
&#xD;
      The quadratus lumborum block (QLB) block is an innovative regional analgesic technique. Its&#xD;
      role as an effective analgesic agent in abdominal surgery is increasing. However, it has not&#xD;
      been studied for pain relief in Australia after cesarean section.&#xD;
&#xD;
      In this study, the investigator aims to compare post-operative analgesia and side effects&#xD;
      between the QLB blocks versus adding morphine the participant's spinal anaesthetic (ITM)&#xD;
      during the elective C/S. Results from this study will provide information on the analgesic&#xD;
      impact of this new and emerging therapy and assist in the development of a larger clinical&#xD;
      trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    We at the Sunshine Coast University Hospital are unable to cope with the extra effort/time&#xD;
    needed to complete this trial properly.&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">November 1, 2019</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>4 groups of 25 patients each. All patients will receive a spinal and a quadratus lumborum type 2 block. The groups will have a combination of ITM / QLB or both or neither.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Double blinded</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>24 hours total intravenous morphine usage via a PCA pump</measure>
    <time_frame>24 hours</time_frame>
    <description>Post operative intravenous morphine use will be noted at 24 hours post cesarean section</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient's side effects within the 24 hours post operative period.</measure>
    <time_frame>24 hours</time_frame>
    <description>Nausea, vomiting, itching, herpes reactivation, urinary retention and sedation will be noted.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Scores within 24 hours post operative period.</measure>
    <time_frame>24 hours</time_frame>
    <description>Using a VAS we will note both dynamic and static pain scores at 24 hours post operative</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Cesarean Section</condition>
  <condition>Pain, Acute</condition>
  <arm_group>
    <arm_group_label>Saline intrathecal as well as saline in Blocks</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>These 25 patients will receive 0.3ml saline added to the spinal anaesthetic and 25 ml saline both sides as a QLB2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline intrathecal as well as local anaesthetic in Blocks</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>These 25 patients will receive 0.3ml saline added to the spinal anaesthetic and 25 ml local anaesthetic both sides as a QLB2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intrathecal morphine as well as local anaesthetic in Blocks</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>These 25 patients will receive 0.3ml (150mcg) morphine added to the spinal anaesthetic and 25 ml local anaesthetic both sides as a QLB2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intrathecal morphine as well as saline in Block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>These 25 patients will receive 0.3ml (150mcg) morphine added to the spinal anaesthetic and 25 ml saline both sides as a QLB2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intrathecal morphine as well as local anaesthetic in Blocks</intervention_name>
    <description>A Quadratus lumborum type 2 block will be performed under ultrasound with 25 ml 0.375% ropivacaine deposited posterior to the quadratus lumborum muscle. 150mcg morphine will be added to the spinal anaesthetic.</description>
    <arm_group_label>Intrathecal morphine as well as local anaesthetic in Blocks</arm_group_label>
    <arm_group_label>Saline intrathecal as well as local anaesthetic in Blocks</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intrathecal morphine as well as saline in Block</intervention_name>
    <description>150mcg morphine will be added to the spinal anaesthetic. 25 ml saline will be used on each side during a quadratus lumborum type 2 block.</description>
    <arm_group_label>Intrathecal morphine as well as local anaesthetic in Blocks</arm_group_label>
    <arm_group_label>Intrathecal morphine as well as saline in Block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Saline intrathecal as well as saline in Blocks</intervention_name>
    <description>0.3 ml saline will be added to the spinal anaesthetic. 25 ml saline will be used on each side during a quadratus lumborum type 2 block.</description>
    <arm_group_label>Saline intrathecal as well as local anaesthetic in Blocks</arm_group_label>
    <arm_group_label>Saline intrathecal as well as saline in Blocks</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Saline intrathecal as well as local anaesthetic in Blocks</intervention_name>
    <description>0.3 ml saline will be added to the spinal anaesthetic. A Quadratus lumborum type 2 block will be performed under ultrasound with 25 ml 0.375% ropivacaine deposited posterior to the quadratus lumborum muscle.</description>
    <arm_group_label>Intrathecal morphine as well as saline in Block</arm_group_label>
    <arm_group_label>Saline intrathecal as well as saline in Blocks</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Anaesthetist trained in QLB and ITM techniques available&#xD;
&#xD;
          -  American Society of Anaesthesiologists PS category client I or II&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Ability to read and understand English&#xD;
&#xD;
          -  Uncomplicated pregnancy at term (&gt;37 weeks completed gestation)&#xD;
&#xD;
          -  Booked elective CS&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications to spinal anaesthesia&#xD;
&#xD;
          -  History of chronic opioid consumption / chronic pain conditions&#xD;
&#xD;
          -  Known allergy to study drugs&#xD;
&#xD;
          -  Weight more than 95kg or body mass index (BMI) more than 35 pre operative&#xD;
&#xD;
          -  Placenta Previa / accreta&#xD;
&#xD;
          -  Obstructive Sleep apnoea&#xD;
&#xD;
          -  Severe asthma unable to tolerate Non steroidal anti inflammatory agents&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female patients undergoing elective cesarean sections</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Willem Basson, FANZCA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sunshine Coast University Hospital</affiliation>
  </overall_official>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>April 15, 2019</last_update_submitted>
  <last_update_submitted_qc>April 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Sunshine Coast Hospital and Health Service</investigator_affiliation>
    <investigator_full_name>Dr Willem Basson</investigator_full_name>
    <investigator_title>Staff Specialist in Anaesthetics</investigator_title>
  </responsible_party>
  <keyword>intrathecal morphine</keyword>
  <keyword>quadratus lumborum type 2 block</keyword>
  <keyword>cesarean section</keyword>
  <keyword>pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Morphine</mesh_term>
    <mesh_term>Anesthetics</mesh_term>
    <mesh_term>Anesthetics, Local</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03267628
org study id: HREC/17/QPCH/121
nct id: NCT03267628
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators are comparing post operative analgesia provided for caesarean section
      patients, with the quadratus lumborum type 2 block and intrathecal morphine.
In Australia the rate of birth via caesarean section (CS) has significantly increased over
      the last twenty years. Improvements in the care of women undergoing CS are important locally,
      nationally and internationally. Compared to women birthing vaginally, women undergoing CS
      experience more adverse events and more pain. Effective pain relief following CS is important
      as it enables early ambulation, encourages maternal bonding, and promotes breastfeeding
      initiation and establishment. Traditional analgesic techniques following CS include opioid
      medications. Whist effective, the use of opioids are associated with frequent and significant
      side effects. Alternative analgesic agents are being explored in an attempt to improve the
      effectiveness of pain relief available to women and clinicians.

      The quadratus lumborum block (QLB) block is an innovative regional analgesic technique. Its
      role as an effective analgesic agent in abdominal surgery is increasing. However, it has not
      been studied for pain relief in Australia after cesarean section.

      In this study, the investigator aims to compare post-operative analgesia and side effects
      between the QLB blocks versus adding morphine the participant's spinal anaesthetic (ITM)
      during the elective C/S. Results from this study will provide information on the analgesic
      impact of this new and emerging therapy and assist in the development of a larger clinical
      trial.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 4 groups of 25 patients each. All patients will receive a spinal and a quadratus lumborum type 2 block. The groups will have a combination of ITM / QLB or both or neither.
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Double blinded
measure: 24 hours total intravenous morphine usage via a PCA pump
time frame: 24 hours
description: Post operative intravenous morphine use will be noted at 24 hours post cesarean section
measure: Patient's side effects within the 24 hours post operative period.
time frame: 24 hours
description: Nausea, vomiting, itching, herpes reactivation, urinary retention and sedation will be noted.
measure: Pain Scores within 24 hours post operative period.
time frame: 24 hours
description: Using a VAS we will note both dynamic and static pain scores at 24 hours post operative
arm group label: Saline intrathecal as well as saline in Blocks
arm group type: Sham Comparator
description: These 25 patients will receive 0.3ml saline added to the spinal anaesthetic and 25 ml saline both sides as a QLB2.
arm group label: Saline intrathecal as well as local anaesthetic in Blocks
arm group type: Active Comparator
description: These 25 patients will receive 0.3ml saline added to the spinal anaesthetic and 25 ml local anaesthetic both sides as a QLB2.
arm group label: Intrathecal morphine as well as local anaesthetic in Blocks
arm group type: Active Comparator
description: These 25 patients will receive 0.3ml (150mcg) morphine added to the spinal anaesthetic and 25 ml local anaesthetic both sides as a QLB2.
arm group label: Intrathecal morphine as well as saline in Block
arm group type: Active Comparator
description: These 25 patients will receive 0.3ml (150mcg) morphine added to the spinal anaesthetic and 25 ml saline both sides as a QLB2.
intervention type: Procedure
intervention name: Intrathecal morphine as well as local anaesthetic in Blocks
description: A Quadratus lumborum type 2 block will be performed under ultrasound with 25 ml 0.375% ropivacaine deposited posterior to the quadratus lumborum muscle. 150mcg morphine will be added to the spinal anaesthetic.
arm group label: Intrathecal morphine as well as local anaesthetic in Blocks
arm group label: Saline intrathecal as well as local anaesthetic in Blocks
intervention type: Procedure
intervention name: Intrathecal morphine as well as saline in Block
description: 150mcg morphine will be added to the spinal anaesthetic. 25 ml saline will be used on each side during a quadratus lumborum type 2 block.
arm group label: Intrathecal morphine as well as local anaesthetic in Blocks
arm group label: Intrathecal morphine as well as saline in Block
intervention type: Procedure
intervention name: Saline intrathecal as well as saline in Blocks
description: 0.3 ml saline will be added to the spinal anaesthetic. 25 ml saline will be used on each side during a quadratus lumborum type 2 block.
arm group label: Saline intrathecal as well as local anaesthetic in Blocks
arm group label: Saline intrathecal as well as saline in Blocks
intervention type: Procedure
intervention name: Saline intrathecal as well as local anaesthetic in Blocks
description: 0.3 ml saline will be added to the spinal anaesthetic. A Quadratus lumborum type 2 block will be performed under ultrasound with 25 ml 0.375% ropivacaine deposited posterior to the quadratus lumborum muscle.
arm group label: Intrathecal morphine as well as saline in Block
arm group label: Saline intrathecal as well as saline in Blocks
criteria: 
gender: Female
gender based: Yes
gender description: Female patients undergoing elective cesarean sections
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Willem Basson, FANZCA
role: Principal Investigator
affiliation: Sunshine Coast University Hospital
responsible party type: Sponsor-Investigator
investigator affiliation: Sunshine Coast Hospital and Health Service
investigator full name: Dr Willem Basson
investigator title: Staff Specialist in Anaesthetics
mesh term: Acute Pain
mesh term: Morphine
mesh term: Anesthetics
mesh term: Anesthetics, Local
sharing ipd: No