<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/NCT03263689</url>
  </required_header>
  <id_info>
    <org_study_id>MUST/19/08-14</org_study_id>
    <nct_id>NCT03263689</nct_id>
  </id_info>
  <brief_title>Transversus Abdominis Plane Block Versus Spinal Morphine After Caesarean Section : A Comparison Study</brief_title>
  <official_title>The Analgesic Effects of Intrathecal Morphine in Comparison to Ultrasound-guided Transversus Abdominis Plane Block After Cesarean Section: a Randomized Controlled Trial at a Ugandan Regional Referral Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mbarara University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mbarara University of Science and Technology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Many counties in sub-Saharan Africa have very limited post-operative nursing capacity, and&#xD;
      relatively little data have been published about post-operative maternal pain control in&#xD;
      these settings. Cesarean section is the most common type of major operation at our&#xD;
      institution, Mbarara Regional Referral Hospital (MRRH), in south-western Uganda.Nursing ward&#xD;
      staffing capacity is low, with much basic nursing care provided by families and friends of&#xD;
      patients. The investigators conducted a study to examine the impact of ITM versus TAP block&#xD;
      in a setting of limited formal nursing oversight.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intrathecal morphine (ITM), administered as a part of spinal anesthesia for caesarian&#xD;
      section, can produce significant post-operative analgesia for several hours. The Tranversus&#xD;
      Abdominis Plane (TAP) Block can also provide prolonged post-operative pain control. A small&#xD;
      number of published studies comparing analgesic outcomes after cesarian section with ITM or&#xD;
      TAP block have reported variable results.Moreover, these studies have been conducted in&#xD;
      countries with extensive post-operative nursing care.&#xD;
&#xD;
      Many counties in sub-Saharan Africa have very limited post-operative nursing capacity, and&#xD;
      relatively little data have been published about post-operative maternal pain control in&#xD;
      these settings. Cesarean section is the most common type of major operation at our&#xD;
      institution, Mbarara Regional Referral Hospital (MRRH), in south-western Uganda.Nursing ward&#xD;
      staffing capacity is low, with much basic nursing care provided by families and friends of&#xD;
      patients. The investigators conducted a study to examine the impact of ITM versus TAP block&#xD;
      in a setting of limited formal nursing oversight.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 15, 2014</start_date>
  <completion_date type="Actual">June 20, 2016</completion_date>
  <primary_completion_date type="Actual">June 20, 2016</primary_completion_date>
  <phase>Phase 3</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 patients in the intrathecal morphine (ITM group) were given a sham block, while the patients in the TAP group were given a TAP block. Sham blocks consisted of a non-invasive ultrasound scan. A blunt needle was gently pressed on either side of the abdomen. Bilateral TAP blocks were placed after ultrasound location of the transversus abdominis and internal oblique muscles, with the injection sites in the Triangle of Petit located at the lateral edge of the mid-abdomen. Following negative aspiration for blood, the local anaesthetic (0.25% bupivacaine with 1:200000 epinephrine) was injected in the transversus abdominis plane under ultrasound visualization in 5 cc aliquots for a total volume of 15cc per side.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>The subjects were randomly assigned to a study group (intrathecal morphine - ITM group - or TAP - TAP group) by a computer random number generator. Patients were blinded to their study allocation. Those in the ITM group were given 100 micrograms of preservative-free morphine in addition to the local anaesthesia (plain hyperbaric bupivacaine 10mgs) intrathecally during the spinal anaesthesia. The TAP group were given only local anaesthesia (plain hyperbaric bupivacaine 10 mgs) during the spinal anaesthesia.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pain measurement</measure>
    <time_frame>at 8 hours after intervention</time_frame>
    <description>Pain measurement using the numerical rating scale (NRS).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain measurement</measure>
    <time_frame>at 16 hours after intervention</time_frame>
    <description>Pain measurement using the numerical rating scale (NRS).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain measurement</measure>
    <time_frame>at 24 hours after intervention</time_frame>
    <description>Pain measurement using the numerical rating scale (NRS)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">130</enrollment>
  <condition>Pregnancy, Ceasarian Section, Anaesthesia</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ITM group were given&#xD;
Local anaesthesia (plain hyperbaric bupivacaine 10mgs) intrathecally during the spinal anaesthesia&#xD;
100 micrograms of preservative-free morphine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>TAP group were given only local anaesthesia (plain hyperbaric bupivacaine 10 mgs) during the spinal anaesthesia.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intrathecal morphine</intervention_name>
    <description>ITM group were given 100 micrograms of preservative-free morphine in addition to the local anaesthesia (plain hyperbaric bupivacaine 10mgs) intrathecally during the spinal anaesthesia</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Intrathecal</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women between the age of 18-45;&#xD;
&#xD;
          2. Greater than 50 kilograms in weight;&#xD;
&#xD;
          3. Routine spinal anesthetic without sedation for an uncomplicated caesarean delivery via&#xD;
             a low, transverse abdominal incision (Pfannenstiel);&#xD;
&#xD;
          4. In good health with no major medical problems including gastric ulcers, liver or renal&#xD;
             dysfunction&#xD;
&#xD;
          5. Able to communicate freely with a provided non-family member interpreter fluent in the&#xD;
             patient's language so that informed consent may be obtained&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with allergies to bupivacaine, paracetamol, or diclofenac;&#xD;
&#xD;
          2. Patients undergoing a surgical approach is other than a low, transverse abdominal&#xD;
             incision (Pfannenstiel);&#xD;
&#xD;
          3. Pre-eclampsia, uterine rupture, placental abruption with this pregnancy;&#xD;
&#xD;
          4. Prior complicated abdominal surgery;&#xD;
&#xD;
          5. Medical history of gastric ulcers, liver or kidney dysfunction; and&#xD;
&#xD;
          6. Patient refusal to be involved in the study. Failure to attain informed consent from&#xD;
             the patient due to age or level of consciousness&#xD;
&#xD;
          7. Voluntary or involuntary withdraw from the study&#xD;
&#xD;
          8. Referral to another health centre or Hospital for further management.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Pregnant women in labor with indication for ceasarian section</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew Kwikiriza, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mbarara University of Science and Technology</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>August 23, 2017</last_update_submitted>
  <last_update_submitted_qc>August 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Morphine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Data will be shared after relevant permissions have been obtained</ipd_description>
  </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/NCT03263689
org study id: MUST/19/08-14
nct id: NCT03263689
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Many counties in sub-Saharan Africa have very limited post-operative nursing capacity, and
      relatively little data have been published about post-operative maternal pain control in
      these settings. Cesarean section is the most common type of major operation at our
      institution, Mbarara Regional Referral Hospital (MRRH), in south-western Uganda.Nursing ward
      staffing capacity is low, with much basic nursing care provided by families and friends of
      patients. The investigators conducted a study to examine the impact of ITM versus TAP block
      in a setting of limited formal nursing oversight.
Intrathecal morphine (ITM), administered as a part of spinal anesthesia for caesarian
      section, can produce significant post-operative analgesia for several hours. The Tranversus
      Abdominis Plane (TAP) Block can also provide prolonged post-operative pain control. A small
      number of published studies comparing analgesic outcomes after cesarian section with ITM or
      TAP block have reported variable results.Moreover, these studies have been conducted in
      countries with extensive post-operative nursing care.

      Many counties in sub-Saharan Africa have very limited post-operative nursing capacity, and
      relatively little data have been published about post-operative maternal pain control in
      these settings. Cesarean section is the most common type of major operation at our
      institution, Mbarara Regional Referral Hospital (MRRH), in south-western Uganda.Nursing ward
      staffing capacity is low, with much basic nursing care provided by families and friends of
      patients. The investigators conducted a study to examine the impact of ITM versus TAP block
      in a setting of limited formal nursing oversight.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The patients in the intrathecal morphine (ITM group) were given a sham block, while the patients in the TAP group were given a TAP block. Sham blocks consisted of a non-invasive ultrasound scan. A blunt needle was gently pressed on either side of the abdomen. Bilateral TAP blocks were placed after ultrasound location of the transversus abdominis and internal oblique muscles, with the injection sites in the Triangle of Petit located at the lateral edge of the mid-abdomen. Following negative aspiration for blood, the local anaesthetic (0.25% bupivacaine with 1:200000 epinephrine) was injected in the transversus abdominis plane under ultrasound visualization in 5 cc aliquots for a total volume of 15cc per side.
primary purpose: Treatment
masking: Single (Participant)
masking description: The subjects were randomly assigned to a study group (intrathecal morphine - ITM group - or TAP - TAP group) by a computer random number generator. Patients were blinded to their study allocation. Those in the ITM group were given 100 micrograms of preservative-free morphine in addition to the local anaesthesia (plain hyperbaric bupivacaine 10mgs) intrathecally during the spinal anaesthesia. The TAP group were given only local anaesthesia (plain hyperbaric bupivacaine 10 mgs) during the spinal anaesthesia.
measure: Pain measurement
time frame: at 8 hours after intervention
description: Pain measurement using the numerical rating scale (NRS).
measure: Pain measurement
time frame: at 16 hours after intervention
description: Pain measurement using the numerical rating scale (NRS).
measure: Pain measurement
time frame: at 24 hours after intervention
description: Pain measurement using the numerical rating scale (NRS)
arm group label: Intervention
arm group type: Experimental
description: ITM group were given
Local anaesthesia (plain hyperbaric bupivacaine 10mgs) intrathecally during the spinal anaesthesia
100 micrograms of preservative-free morphine.
arm group label: Control
arm group type: Active Comparator
description: TAP group were given only local anaesthesia (plain hyperbaric bupivacaine 10 mgs) during the spinal anaesthesia.
intervention type: Drug
intervention name: Intrathecal morphine
description: ITM group were given 100 micrograms of preservative-free morphine in addition to the local anaesthesia (plain hyperbaric bupivacaine 10mgs) intrathecally during the spinal anaesthesia
arm group label: Control
arm group label: Intervention
other name: Intrathecal
criteria: 
gender: Female
gender based: Yes
gender description: Pregnant women in labor with indication for ceasarian section
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Andrew Kwikiriza, MD
role: Principal Investigator
affiliation: Mbarara University of Science and Technology
responsible party type: Sponsor
mesh term: Morphine
sharing ipd: Undecided
ipd description: Data will be shared after relevant permissions have been obtained