<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/NCT03252561</url>
  </required_header>
  <id_info>
    <org_study_id>Sponsorship No. 249</org_study_id>
    <nct_id>NCT03252561</nct_id>
  </id_info>
  <brief_title>TAP Block for Laparoscopic Appendicectomy in Adults</brief_title>
  <official_title>Ultrasound Guided Transversus Abdominis Plane (TAP) Block for Postoperative Analgesia After Laparoscopic Appendicectomy in Adults: A Double Blind Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oxford University Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oxford University Hospitals NHS Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Laparoscopic (key-hole) appendicectomy is a minimally invasive procedure when compared to&#xD;
      open large bowel resection, but is still associated with a significant amount of pain and&#xD;
      discomfort. Analgesia is commonly provided by a multi-modal technique involving varying&#xD;
      combinations of paracetamol, Non steroidal anti-inflammatory drugs (NSAIDs), regional&#xD;
      analgesia and oral or parenteral opioids. Opioids are associated with an increased incidence&#xD;
      of nausea, vomiting and sedation which can complicate post-operative recovery. Different&#xD;
      techniques of intraoperative infiltration of local anaesthetic to control postoperative pain&#xD;
      are also being used. Their perceived benefits are thought to relate to reduced opioid&#xD;
      consumption and therefore reduced opioid side effects.&#xD;
&#xD;
      Transversus Abdominis Plane (TAP) block is a technique which numbs the nerves carrying pain&#xD;
      sensation from the abdominal wall and provides effective and safe analgesia with minimal&#xD;
      systemic side effects. Their perceived benefits are thought to relate to reduced opioid&#xD;
      consumption and therefore reduced opioid side effects. The investigators believe ultrasound&#xD;
      guided TAP blocks will reduce pain and morphine consumption with a resultant improved patient&#xD;
      satisfaction, a reduction in post-operative nausea and vomiting and earlier hospital&#xD;
      discharge.&#xD;
&#xD;
      The key research question the investigators are trying to answer is whether TAP block provide&#xD;
      better pain relief than local anaesthetic infiltration of the laparoscopic port sites. Both&#xD;
      techniques are currently being used in the investigator's hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Summary of Study Design: The study will be a double blind randomised controlled trial with&#xD;
      patients undergoing laparoscopic appendicectomy randomly allocated into two groups. The study&#xD;
      group will receive bilateral TAP blocks and the control group will receive local anaesthetic&#xD;
      infiltration of the laparoscopic port sites&#xD;
&#xD;
      A double blind design was chosen to eliminate patient and observer bias in reporting of pain&#xD;
      scores.&#xD;
&#xD;
      The presence of the control arm will ensure that any difference observed will be due to the&#xD;
      effect of sensory nerve block due to the TAP block than due to the systemic effect of the&#xD;
      injected local anaesthetic.&#xD;
&#xD;
      The null hypothesis will be that there is no difference between the groups in the amount of&#xD;
      opioids consumed by the patients during 24 hours after the operation. The investigators chose&#xD;
      this measurement as an objective but indirect measurement of efficacy of TAP block and pain&#xD;
      relief thus received. Measurement of pain with various scoring methods are reliable only when&#xD;
      concurrent reduction in consumption of pain killers are demonstrated.&#xD;
&#xD;
      Recruitment and randomisation:&#xD;
&#xD;
      All patients meeting the inclusion criteria will receive a patient information leaflet about&#xD;
      the study during the procedure and investigators will gain informed consent during the&#xD;
      procedure consultation. Investigators aim to recruit 288 patients with 144 patients in each&#xD;
      group.&#xD;
&#xD;
      Informed consent will be taken the evening before, or on the morning of, surgery. Patients&#xD;
      will then be randomly allocated into either the study group or a control group. Randomisation&#xD;
      will occur by using computer generated random numbers using the block randomisation method.&#xD;
      Group allocation will be kept in a consecutively numbered, opaque, sealed envelope in the&#xD;
      controlled drugs cupboard in theatre-4/emergency theatre anaesthetic room of the John&#xD;
      Radcliffe Hospital. Once the patient has consented, the anaesthetist will open the&#xD;
      corresponding numbered envelope and perform bilateral TAP blocks after induction of general&#xD;
      anaesthesia if the patient is in the study group. The surgeons will infiltrate the port sites&#xD;
      with local anaesthetic at the end of the procedure if the patient is in the control group.&#xD;
&#xD;
      Blinding:&#xD;
&#xD;
      The study group will receive bilateral TAP blocks with 20mls 0.25% bupivacaine on each side&#xD;
      and the skin punctures on either sides will be covered with a small plaster. Patients in the&#xD;
      control group will receive subcutaneous infiltration of the laparoscopic port sites and&#xD;
      specimen extraction site with equivalent amount bupivacaine at the end of the procedure and&#xD;
      small plasters will be stuck on either flanks approximately where the skin punctures for TAP&#xD;
      block will be made.&#xD;
&#xD;
      The assessor of pain scores and morphine doses (Recovery nurse, Ward Nursing Staff &amp; SEU&#xD;
      Foundation Doctor) and the patient will be blinded to group allocation.&#xD;
&#xD;
      Patient: Plasters will be stuck on flanks of all the patients, both study and control group,&#xD;
      so that patient will not know if they have received TAP block.&#xD;
&#xD;
      Recovery nurse: During handover to recovery the anaesthetist and scrub nurse will not mention&#xD;
      group allocation.&#xD;
&#xD;
      SEU Foundation Doctor: The foundation doctor who will be following up patients on the ward&#xD;
      will not be present in the operating theatre, ensuring that they are blinded to the technique&#xD;
      used.&#xD;
&#xD;
      The study duration will be from induction of anaesthesia until the patients are medically fit&#xD;
      for discharge from hospital. No extra visits other than routinely required for the surgical&#xD;
      procedure are expected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study no longer feasible&#xD;
  </why_stopped>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Opioid consumption in the first 12 hours after the operation</measure>
    <time_frame>12 hours</time_frame>
    <description>The primary endpoint will be consumption of morphine or other opioids (including tramadol) in the first 12 hours after the operation. This will be recorded from the drug chart. Morphine equivalents include fentanyl, codeine and tramadol and will be converted into total morphine consumption using recognised conversion ratios.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Numerical rating pain scores at emergence, 6, 12, 24 hours postoperatively</measure>
    <time_frame>24 hours after the operation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first request for rescue analgesia</measure>
    <time_frame>24 hours after the operation</time_frame>
    <description>The time will be calculated from the drug chart looking up when the first dose of rescue opioid was administered</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nausea score at emergence, 6, 12, 24 hours postoperatively</measure>
    <time_frame>24 hours after the operation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total length of hospital stay</measure>
    <time_frame>After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected length of 1-5 days</time_frame>
    <description>Time will be calculated from the medical notes, when the decision that the patient is medically fit to be discharged was made</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid consumption at 24 hours</measure>
    <time_frame>24 hours after the operation</time_frame>
    <description>Consumption of morphine or other opioids (including tramadol) in the first 24 hours after the operation. This will be recorded from the drug chart. Morphine equivalents include fentanyl, codeine and tramadol and will be converted into total morphine consumption using recognised conversion ratios</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Acute Appendicitis</condition>
  <arm_group>
    <arm_group_label>TAP block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this arm will receive ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Local anaesthetic infiltration</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Laparoscopic port sites will be infiltrated with a total of 20 mls 0.5% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ultrasound guided Transversus Abdominis Plane (TAP) bock</intervention_name>
    <description>Ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster</description>
    <arm_group_label>TAP block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Local anaesthetic infiltration of laparoscopic port sites</intervention_name>
    <description>Laparoscopic port sites will be infiltrated with a total of 20 mls 0.5% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.</description>
    <arm_group_label>Local anaesthetic infiltration</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants willing and able to give informed consent for participation in the study&#xD;
&#xD;
          -  Male or Female, aged 16 years or above&#xD;
&#xD;
          -  Undergoing laparoscopic appendicectomy for a clinical diagnosis of appendicitis&#xD;
&#xD;
          -  American Society of Anaesthetists physical status (ASA) 1-3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Opioid tolerance&#xD;
&#xD;
          -  Chronic abdominal pain&#xD;
&#xD;
          -  Allergy/Intolerance: Morphine, local anaesthetics, tramadol&#xD;
&#xD;
          -  BMI (Body Mass Index) &gt;35 Kg/M2&#xD;
&#xD;
          -  Previous major abdominal surgery&#xD;
&#xD;
          -  High likelihood of conversion of open procedure&#xD;
&#xD;
          -  Patients unable to communicate in written and spoken English&#xD;
&#xD;
          -  Weight less than 50 kg&#xD;
&#xD;
          -  ASA &gt; 3&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Silva, MBBS,MD,FRCS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Consultant Upper G Surgeon</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nicholas Crabtree, MBChB,FRCA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Consultant Anaesthetist</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>John Radcliffe Hospital</name>
      <address>
        <city>Oxford</city>
        <zip>OX3 9DU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Niraj G, Searle A, Mathews M, Misra V, Baban M, Kiani S, Wong M. Analgesic efficacy of ultrasound-guided transversus abdominis plane block in patients undergoing open appendicectomy. Br J Anaesth. 2009 Oct;103(4):601-5. doi: 10.1093/bja/aep175. Epub 2009 Jun 26.</citation>
    <PMID>19561014</PMID>
  </reference>
  <reference>
    <citation>Sandeman DJ, Bennett M, Dilley AV, Perczuk A, Lim S, Kelly KJ. Ultrasound-guided transversus abdominis plane blocks for laparoscopic appendicectomy in children: a prospective randomized trial. Br J Anaesth. 2011 Jun;106(6):882-6. doi: 10.1093/bja/aer069. Epub 2011 Apr 18.</citation>
    <PMID>21504934</PMID>
  </reference>
  <reference>
    <citation>McDonnell JG, O'Donnell BD, Farrell T, Gough N, Tuite D, Power C, Laffey JG. Transversus abdominis plane block: a cadaveric and radiological evaluation. Reg Anesth Pain Med. 2007 Sep-Oct;32(5):399-404. doi: 10.1016/j.rapm.2007.03.011.</citation>
    <PMID>17961838</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>April 20, 2015</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>June 12, 2020</last_update_submitted>
  <last_update_submitted_qc>June 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>TAP block</keyword>
  <keyword>Acute Appendicitis</keyword>
  <keyword>Post-operative analgesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Appendicitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
    <mesh_term>Anesthetics, Local</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/NCT03252561
org study id: Sponsorship No. 249
nct id: NCT03252561
lead sponsor: 
has dmc: No
Laparoscopic (key-hole) appendicectomy is a minimally invasive procedure when compared to
      open large bowel resection, but is still associated with a significant amount of pain and
      discomfort. Analgesia is commonly provided by a multi-modal technique involving varying
      combinations of paracetamol, Non steroidal anti-inflammatory drugs (NSAIDs), regional
      analgesia and oral or parenteral opioids. Opioids are associated with an increased incidence
      of nausea, vomiting and sedation which can complicate post-operative recovery. Different
      techniques of intraoperative infiltration of local anaesthetic to control postoperative pain
      are also being used. Their perceived benefits are thought to relate to reduced opioid
      consumption and therefore reduced opioid side effects.

      Transversus Abdominis Plane (TAP) block is a technique which numbs the nerves carrying pain
      sensation from the abdominal wall and provides effective and safe analgesia with minimal
      systemic side effects. Their perceived benefits are thought to relate to reduced opioid
      consumption and therefore reduced opioid side effects. The investigators believe ultrasound
      guided TAP blocks will reduce pain and morphine consumption with a resultant improved patient
      satisfaction, a reduction in post-operative nausea and vomiting and earlier hospital
      discharge.

      The key research question the investigators are trying to answer is whether TAP block provide
      better pain relief than local anaesthetic infiltration of the laparoscopic port sites. Both
      techniques are currently being used in the investigator's hospital.
Summary of Study Design: The study will be a double blind randomised controlled trial with
      patients undergoing laparoscopic appendicectomy randomly allocated into two groups. The study
      group will receive bilateral TAP blocks and the control group will receive local anaesthetic
      infiltration of the laparoscopic port sites

      A double blind design was chosen to eliminate patient and observer bias in reporting of pain
      scores.

      The presence of the control arm will ensure that any difference observed will be due to the
      effect of sensory nerve block due to the TAP block than due to the systemic effect of the
      injected local anaesthetic.

      The null hypothesis will be that there is no difference between the groups in the amount of
      opioids consumed by the patients during 24 hours after the operation. The investigators chose
      this measurement as an objective but indirect measurement of efficacy of TAP block and pain
      relief thus received. Measurement of pain with various scoring methods are reliable only when
      concurrent reduction in consumption of pain killers are demonstrated.

      Recruitment and randomisation:

      All patients meeting the inclusion criteria will receive a patient information leaflet about
      the study during the procedure and investigators will gain informed consent during the
      procedure consultation. Investigators aim to recruit 288 patients with 144 patients in each
      group.

      Informed consent will be taken the evening before, or on the morning of, surgery. Patients
      will then be randomly allocated into either the study group or a control group. Randomisation
      will occur by using computer generated random numbers using the block randomisation method.
      Group allocation will be kept in a consecutively numbered, opaque, sealed envelope in the
      controlled drugs cupboard in theatre-4/emergency theatre anaesthetic room of the John
      Radcliffe Hospital. Once the patient has consented, the anaesthetist will open the
      corresponding numbered envelope and perform bilateral TAP blocks after induction of general
      anaesthesia if the patient is in the study group. The surgeons will infiltrate the port sites
      with local anaesthetic at the end of the procedure if the patient is in the control group.

      Blinding:

      The study group will receive bilateral TAP blocks with 20mls 0.25% bupivacaine on each side
      and the skin punctures on either sides will be covered with a small plaster. Patients in the
      control group will receive subcutaneous infiltration of the laparoscopic port sites and
      specimen extraction site with equivalent amount bupivacaine at the end of the procedure and
      small plasters will be stuck on either flanks approximately where the skin punctures for TAP
      block will be made.

      The assessor of pain scores and morphine doses (Recovery nurse, Ward Nursing Staff & SEU
      Foundation Doctor) and the patient will be blinded to group allocation.

      Patient: Plasters will be stuck on flanks of all the patients, both study and control group,
      so that patient will not know if they have received TAP block.

      Recovery nurse: During handover to recovery the anaesthetist and scrub nurse will not mention
      group allocation.

      SEU Foundation Doctor: The foundation doctor who will be following up patients on the ward
      will not be present in the operating theatre, ensuring that they are blinded to the technique
      used.

      The study duration will be from induction of anaesthesia until the patients are medically fit
      for discharge from hospital. No extra visits other than routinely required for the surgical
      procedure are expected.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Opioid consumption in the first 12 hours after the operation
time frame: 12 hours
description: The primary endpoint will be consumption of morphine or other opioids (including tramadol) in the first 12 hours after the operation. This will be recorded from the drug chart. Morphine equivalents include fentanyl, codeine and tramadol and will be converted into total morphine consumption using recognised conversion ratios.
measure: Numerical rating pain scores at emergence, 6, 12, 24 hours postoperatively
time frame: 24 hours after the operation
measure: Time to first request for rescue analgesia
time frame: 24 hours after the operation
description: The time will be calculated from the drug chart looking up when the first dose of rescue opioid was administered
measure: Nausea score at emergence, 6, 12, 24 hours postoperatively
time frame: 24 hours after the operation
measure: Total length of hospital stay
time frame: After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected length of 1-5 days
description: Time will be calculated from the medical notes, when the decision that the patient is medically fit to be discharged was made
measure: Opioid consumption at 24 hours
time frame: 24 hours after the operation
description: Consumption of morphine or other opioids (including tramadol) in the first 24 hours after the operation. This will be recorded from the drug chart. Morphine equivalents include fentanyl, codeine and tramadol and will be converted into total morphine consumption using recognised conversion ratios
arm group label: TAP block
arm group type: Experimental
description: Patients in this arm will receive ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster
arm group label: Local anaesthetic infiltration
arm group type: Active Comparator
description: Laparoscopic port sites will be infiltrated with a total of 20 mls 0.5% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.
intervention type: Procedure
intervention name: Ultrasound guided Transversus Abdominis Plane (TAP) bock
description: Ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster
arm group label: TAP block
intervention type: Procedure
intervention name: Local anaesthetic infiltration of laparoscopic port sites
description: Laparoscopic port sites will be infiltrated with a total of 20 mls 0.5% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.
arm group label: Local anaesthetic infiltration
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Silva, MBBS,MD,FRCS
role: Principal Investigator
affiliation: Consultant Upper G Surgeon
last name: Nicholas Crabtree, MBChB,FRCA
role: Principal Investigator
affiliation: Consultant Anaesthetist
facility: 
country: United Kingdom
citation: Niraj G, Searle A, Mathews M, Misra V, Baban M, Kiani S, Wong M. Analgesic efficacy of ultrasound-guided transversus abdominis plane block in patients undergoing open appendicectomy. Br J Anaesth. 2009 Oct;103(4):601-5. doi: 10.1093/bja/aep175. Epub 2009 Jun 26.
PMID: 19561014
citation: Sandeman DJ, Bennett M, Dilley AV, Perczuk A, Lim S, Kelly KJ. Ultrasound-guided transversus abdominis plane blocks for laparoscopic appendicectomy in children: a prospective randomized trial. Br J Anaesth. 2011 Jun;106(6):882-6. doi: 10.1093/bja/aer069. Epub 2011 Apr 18.
PMID: 21504934
citation: McDonnell JG, O'Donnell BD, Farrell T, Gough N, Tuite D, Power C, Laffey JG. Transversus abdominis plane block: a cadaveric and radiological evaluation. Reg Anesth Pain Med. 2007 Sep-Oct;32(5):399-404. doi: 10.1016/j.rapm.2007.03.011.
PMID: 17961838
responsible party type: Sponsor
mesh term: Appendicitis
mesh term: Anesthetics
mesh term: Anesthetics, Local