<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/NCT02259374</url>
  </required_header>
  <id_info>
    <org_study_id>2014/729/D</org_study_id>
    <nct_id>NCT02259374</nct_id>
  </id_info>
  <brief_title>Use of Tap Block in Patients After Hysterectomy</brief_title>
  <official_title>Use of Tap Block in Patients After Hysterectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Singapore General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Singapore General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      TAP block performed under ultrasound guidance is used as part of multimodal analgesia to&#xD;
      relieve pain after abdominal surgery in our hospital. Choices of local anaesthetic used&#xD;
      include bupivacaine and ropivacaine. Local anaesthetic works by inhibiting nerve transmission&#xD;
      of pain from the site of tissue injury. An important component of the pain experienced by&#xD;
      patients after abdominal surgery derives from the abdominal wall incision. The abdominal wall&#xD;
      sensory afferents course through the transversus abdominis (neurofascial) plane superficial&#xD;
      to the transversus abdominis muscle. Single shot TAP block has been shown to provide pain&#xD;
      relief of up to 24h in surgeries involving pfannenstiel incisions, hence a study period of&#xD;
      24h is chosen in patients undergoing hysterectomy.&#xD;
&#xD;
      This study was designed to test the hypothesis that the TAP block, as part of a multimodal&#xD;
      analgesic regimen, even at a lower concentration, would provide effective analgesia in the&#xD;
      first 24 h after hysterectomy, in comparison to a higher concentration of 0.4% ropivacaine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Our study hypothesis is that TAP block performed with 0.2% ropivacaine is not inferior to&#xD;
      that using 0.4% ropivacaine.&#xD;
&#xD;
      The primary outcome measure in this study was 24 h morphine consumption. Secondary outcome&#xD;
      measures included time to first request for morphine, VAS scores, and side effects associated&#xD;
      with morphine consumption which include nausea, vomiting, sedation, pruritus, as well as&#xD;
      patient satisfaction.&#xD;
&#xD;
      Our study hypothesis is that TAP block performed with 0.2% ropivacaine 40ml is not inferior&#xD;
      to that using 0.4% ropivacaine 40ml, in terms of analgesia in the first 24h.&#xD;
&#xD;
      Primary Objectives Morphine consumption in the first 24h should not differ between the 2&#xD;
      groups by more than 10mg.&#xD;
&#xD;
      Secondary Objectives Secondary objectives are to show that morphine side effects are similar&#xD;
      in the two groups if a lower ropivacaine provides similar pain relief as higher&#xD;
      concentration. Patient satisfaction is also recorded.&#xD;
&#xD;
      54 patients undergoing hysterectomy will be recruited from SGH.&#xD;
&#xD;
      Criteria for Recruitment and Recruitment Process Patients will be shortlisted from the&#xD;
      surgical list the week prior to surgery. Patients seen in the pre anaesthetic assessment&#xD;
      clinic will also be invited to take part in the study. A simple history and physical&#xD;
      assessment will determine eligibility. Patients fitting the inclusion criteria will be&#xD;
      approached for the study with the emphasis that participation is voluntary and refusal to&#xD;
      participate will not affect subsequent conduct of anaesthesia or care. Patient's wishes will&#xD;
      be respected should she request not to participate&#xD;
&#xD;
      STUDY DESIGN Double blind randomise control trial. Study design is non-inferiority trial&#xD;
      testing 0.2% ropivacaine vs 0.4% ropivacaine. Expected 1 year to complete recruitment of 54&#xD;
      patients. All patients are expected to participate in the study for a period of 24h and will&#xD;
      be followup during their convalescence in the hospital. There will be no change in scheduling&#xD;
      of operation or additional visits for the purpose of the study.&#xD;
&#xD;
      Ultrasound images of the block may be stored in the thumb drive. However, the images will not&#xD;
      be linked to patient identifiers. It will be stored in password protected thumb drive and&#xD;
      kept in the department under lock and key.&#xD;
&#xD;
      It may be used for illustration if the research is published in a scientific journal.&#xD;
&#xD;
      Randomisation and Blinding Patients will be randomised into of the 2 groups - 0.2% or 0.4%&#xD;
      ropivacaine group. The allocation sequence will be generated by a random number table, and&#xD;
      group allocation will be concealed in sealed, opaque envelopes, which will not be opened&#xD;
      until just prior to block performance.&#xD;
&#xD;
      The anaesthesiologist performing the block and anaesthesia will not be blinded. However, the&#xD;
      patient, surgeon and researcher collecting subsequent patient data will be blinded.&#xD;
&#xD;
      Randomisation code will be broken after the final analysis of the study results. As both&#xD;
      study groups involve the use of ropivacaine at concentration below the maximum recommended&#xD;
      dose, the likelihood of needing to break the randomisation code is low. However, should that&#xD;
      become necessary, the study PI can break the code.&#xD;
&#xD;
      Study Visits and Procedures Study visit 1: recruitment during pre-anaesthesia visit a day&#xD;
      before surgery Procedure: Bilateral TAP block after surgery, before reversal of anaesthesia.&#xD;
      Followup for 24h, which includes 1 study visit to elicit pain scores and side effects of&#xD;
      opioids.&#xD;
&#xD;
      Screening Visits and Procedures History and physical examination are required to evaluate&#xD;
      recruitment criteria. Patients will be invited to participate in the study after meeting&#xD;
      inclusion criteria.&#xD;
&#xD;
      Study Visits and Procedures&#xD;
&#xD;
      1 visit in the post operative period.&#xD;
&#xD;
      Final Study Visit:&#xD;
&#xD;
      Patient will be seen once after operation in the first post operative day to assess for VAS&#xD;
      scores, and side effects associated with morphine consumption which include nausea, vomiting,&#xD;
      sedation, pruritus, as well as patient satisfaction.&#xD;
&#xD;
      Post Study Follow up and Procedures Patient will be seen once after operation in the first&#xD;
      post operative day to assess for VAS scores, and side effects associated with morphine&#xD;
      consumption which include nausea, vomiting, sedation, pruritus, as well as patient&#xD;
      satisfaction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">October 2015</completion_date>
  <primary_completion_date type="Anticipated">October 2015</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Morphine consumption in the first 24 hours</measure>
    <time_frame>24hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Morphine side effects</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">54</enrollment>
  <condition>Abdominal Hysterectomy (&amp; Wertheim)</condition>
  <arm_group>
    <arm_group_label>TAP BLOCK 0.2% ROPIVACAINE</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomised into this group will receive bilateral TAP block (single shot) with 0.2% ropivacaine after hysterectomy.&#xD;
Intervention: TAP block Dose: 20 ml 0.2% ropivacaine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAP BLOCK 0.4% ROPIVACAINE</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomised into this group will receive bilateral TAP block (single shot) with 0.4% ropivacaine after hysterectomy.&#xD;
Intervention: TAP block Dose: 20 ml 0.4% ropivacaine</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TAP BLOCK 0.2% ROPIVACAINE</intervention_name>
    <description>Patients randomised to this group will receive 20 ml 0.2% Ropivacaine for bilateral TAP block after hysterectomy</description>
    <arm_group_label>TAP BLOCK 0.2% ROPIVACAINE</arm_group_label>
    <arm_group_label>TAP BLOCK 0.4% ROPIVACAINE</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TAP BLOCK 0.4% ROPIVACAINE</intervention_name>
    <description>Patients randomised to this group will receive 20 ml 0.4% Ropivacaine for bilateral TAP block after hysterectomy</description>
    <arm_group_label>TAP BLOCK 0.2% ROPIVACAINE</arm_group_label>
    <arm_group_label>TAP BLOCK 0.4% ROPIVACAINE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  - ASA 1-3&#xD;
&#xD;
          -  age 21-60&#xD;
&#xD;
          -  undergoing open hysterectomy as planned by the surgeons&#xD;
&#xD;
          -  able to provide informed consent. A upper limit age of 60 is chosen because elderly&#xD;
             patients may have reduced requirements for analgesia and may be more sensitive to&#xD;
             effects of opioids.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - chronic pain/ opioid usage&#xD;
&#xD;
          -  allergy to study drugs&#xD;
&#xD;
          -  BMI&gt;35&#xD;
&#xD;
          -  Weight &lt;50&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>October 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>October 5, 2014</last_update_submitted>
  <last_update_submitted_qc>October 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Singapore General Hospital</investigator_affiliation>
    <investigator_full_name>thong sze ying</investigator_full_name>
    <investigator_title>ASSOCIATE CONSULTANT</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ropivacaine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02259374
org study id: 2014/729/D
nct id: NCT02259374
lead sponsor: 
has dmc: Yes
TAP block performed under ultrasound guidance is used as part of multimodal analgesia to
      relieve pain after abdominal surgery in our hospital. Choices of local anaesthetic used
      include bupivacaine and ropivacaine. Local anaesthetic works by inhibiting nerve transmission
      of pain from the site of tissue injury. An important component of the pain experienced by
      patients after abdominal surgery derives from the abdominal wall incision. The abdominal wall
      sensory afferents course through the transversus abdominis (neurofascial) plane superficial
      to the transversus abdominis muscle. Single shot TAP block has been shown to provide pain
      relief of up to 24h in surgeries involving pfannenstiel incisions, hence a study period of
      24h is chosen in patients undergoing hysterectomy.

      This study was designed to test the hypothesis that the TAP block, as part of a multimodal
      analgesic regimen, even at a lower concentration, would provide effective analgesia in the
      first 24 h after hysterectomy, in comparison to a higher concentration of 0.4% ropivacaine.
Our study hypothesis is that TAP block performed with 0.2% ropivacaine is not inferior to
      that using 0.4% ropivacaine.

      The primary outcome measure in this study was 24 h morphine consumption. Secondary outcome
      measures included time to first request for morphine, VAS scores, and side effects associated
      with morphine consumption which include nausea, vomiting, sedation, pruritus, as well as
      patient satisfaction.

      Our study hypothesis is that TAP block performed with 0.2% ropivacaine 40ml is not inferior
      to that using 0.4% ropivacaine 40ml, in terms of analgesia in the first 24h.

      Primary Objectives Morphine consumption in the first 24h should not differ between the 2
      groups by more than 10mg.

      Secondary Objectives Secondary objectives are to show that morphine side effects are similar
      in the two groups if a lower ropivacaine provides similar pain relief as higher
      concentration. Patient satisfaction is also recorded.

      54 patients undergoing hysterectomy will be recruited from SGH.

      Criteria for Recruitment and Recruitment Process Patients will be shortlisted from the
      surgical list the week prior to surgery. Patients seen in the pre anaesthetic assessment
      clinic will also be invited to take part in the study. A simple history and physical
      assessment will determine eligibility. Patients fitting the inclusion criteria will be
      approached for the study with the emphasis that participation is voluntary and refusal to
      participate will not affect subsequent conduct of anaesthesia or care. Patient's wishes will
      be respected should she request not to participate

      STUDY DESIGN Double blind randomise control trial. Study design is non-inferiority trial
      testing 0.2% ropivacaine vs 0.4% ropivacaine. Expected 1 year to complete recruitment of 54
      patients. All patients are expected to participate in the study for a period of 24h and will
      be followup during their convalescence in the hospital. There will be no change in scheduling
      of operation or additional visits for the purpose of the study.

      Ultrasound images of the block may be stored in the thumb drive. However, the images will not
      be linked to patient identifiers. It will be stored in password protected thumb drive and
      kept in the department under lock and key.

      It may be used for illustration if the research is published in a scientific journal.

      Randomisation and Blinding Patients will be randomised into of the 2 groups - 0.2% or 0.4%
      ropivacaine group. The allocation sequence will be generated by a random number table, and
      group allocation will be concealed in sealed, opaque envelopes, which will not be opened
      until just prior to block performance.

      The anaesthesiologist performing the block and anaesthesia will not be blinded. However, the
      patient, surgeon and researcher collecting subsequent patient data will be blinded.

      Randomisation code will be broken after the final analysis of the study results. As both
      study groups involve the use of ropivacaine at concentration below the maximum recommended
      dose, the likelihood of needing to break the randomisation code is low. However, should that
      become necessary, the study PI can break the code.

      Study Visits and Procedures Study visit 1: recruitment during pre-anaesthesia visit a day
      before surgery Procedure: Bilateral TAP block after surgery, before reversal of anaesthesia.
      Followup for 24h, which includes 1 study visit to elicit pain scores and side effects of
      opioids.

      Screening Visits and Procedures History and physical examination are required to evaluate
      recruitment criteria. Patients will be invited to participate in the study after meeting
      inclusion criteria.

      Study Visits and Procedures

      1 visit in the post operative period.

      Final Study Visit:

      Patient will be seen once after operation in the first post operative day to assess for VAS
      scores, and side effects associated with morphine consumption which include nausea, vomiting,
      sedation, pruritus, as well as patient satisfaction.

      Post Study Follow up and Procedures Patient will be seen once after operation in the first
      post operative day to assess for VAS scores, and side effects associated with morphine
      consumption which include nausea, vomiting, sedation, pruritus, as well as patient
      satisfaction.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Morphine consumption in the first 24 hours
time frame: 24hours
measure: Morphine side effects
time frame: 24 hours
measure: Patient satisfaction
time frame: 24 hours
arm group label: TAP BLOCK 0.2% ROPIVACAINE
arm group type: Active Comparator
description: Patients randomised into this group will receive bilateral TAP block (single shot) with 0.2% ropivacaine after hysterectomy.
Intervention: TAP block Dose: 20 ml 0.2% ropivacaine
arm group label: TAP BLOCK 0.4% ROPIVACAINE
arm group type: Active Comparator
description: Patients randomised into this group will receive bilateral TAP block (single shot) with 0.4% ropivacaine after hysterectomy.
Intervention: TAP block Dose: 20 ml 0.4% ropivacaine
intervention type: Procedure
intervention name: TAP BLOCK 0.2% ROPIVACAINE
description: Patients randomised to this group will receive 20 ml 0.2% Ropivacaine for bilateral TAP block after hysterectomy
arm group label: TAP BLOCK 0.2% ROPIVACAINE
arm group label: TAP BLOCK 0.4% ROPIVACAINE
intervention type: Procedure
intervention name: TAP BLOCK 0.4% ROPIVACAINE
description: Patients randomised to this group will receive 20 ml 0.4% Ropivacaine for bilateral TAP block after hysterectomy
arm group label: TAP BLOCK 0.2% ROPIVACAINE
arm group label: TAP BLOCK 0.4% ROPIVACAINE
criteria: 
gender: Female
minimum age: 21 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Singapore General Hospital
investigator full name: thong sze ying
investigator title: ASSOCIATE CONSULTANT
mesh term: Ropivacaine