<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/NCT03797703</url>
  </required_header>
  <id_info>
    <org_study_id>AHC-6999-M5000223</org_study_id>
    <nct_id>NCT03797703</nct_id>
  </id_info>
  <brief_title>Efficacy of Lidocaine Gel Enema After Endoscopic Hemorrhoid Band Ligation for Relief of Post Procedural Pain</brief_title>
  <official_title>Efficacy of Lidocaine Gel Enema After Endoscopic Hemorrhoid Band Ligation for Relief of Post Procedural Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Advocate Health Care</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Advocate Health Care</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective study to assess the utility of Lidocaine Hydrochloride 2% gel enema&#xD;
      (Hi-Tech Pharmacal Co., Inc.) in reducing post-procedural pain after endoscopic band ligation&#xD;
      of internal hemorrhoids. Briefly, patients will be consented prior to entry into the study.&#xD;
      During the endoscopic band ligation procedure, patients will be blindly placed into the&#xD;
      treatment arm or control arm. The treatment arm will receive 15 ml enema of lidocaine gel&#xD;
      immediately upon cessation of the procedure. In the placebo arm, oral pain medications will&#xD;
      be provided. Researchers will assess pain following the procedure at 1 hour, 24 hours and 48&#xD;
      hours via telephone call. Another telephone call will be performed at 72 to 96 hours to&#xD;
      assess any side effects of the medication.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective single center study to evaluate side effects and efficacy of a&#xD;
      lidocaine jelly 2% enema following endoscopic hemorrhoid band ligation. The investigators&#xD;
      will administer a single dose of 15 mL lidocaine jelly 2%, obtained from Advocate main&#xD;
      pharmacy, as an enema immediately post procedure. Patients will not be permitted to&#xD;
      self-administer additional doses following discharge.&#xD;
&#xD;
      Prior to being enrolled in the study, the clinician will perform a Comprehensive Metabolic&#xD;
      Panel and Complete Blood Count. When appropriate, a urine pregnancy test will be performed&#xD;
      prior to enrollment. The investigators will assess for any signs or symptoms of liver&#xD;
      disease. These assessments will occur within one month of the procedure date. If the patient&#xD;
      has any signs of renal or hepatic impairment (creatinine greater than 2 or Childs Pugh Class&#xD;
      3), they will be excluded from the study. The researchers will also exclude patients with any&#xD;
      history of arrhythmias or who are currently on anti-arrhythmic medications. Once the patient&#xD;
      is deemed safe to proceed, the lidocaine gel enema will be placed at the cessation of the&#xD;
      procedure by the investigator. At the time of the procedure, the clinician will assess and&#xD;
      use their best judgement to determine if the rectal mucosa is generally intact by visual&#xD;
      inspection. If the mucosa remains intact, the subject will be able to be included in the&#xD;
      study. However, if the rectal mucosa is traumatized the subject will be excluded and will not&#xD;
      participate in the randomized treatment.&#xD;
&#xD;
      Following the procedure, the patient will be monitored closely with a one-on one registered&#xD;
      nurse for 4 hours in an observation unit. Vital signs will be taken every 5 minutes, as well&#xD;
      as continuous EKG monitoring and pulse oximetry monitoring. If any adverse side effects&#xD;
      occur, the physician is immediately available for further management and admission to the&#xD;
      hospital if needed. Upon completion of the 4-hour observation period, the participants will&#xD;
      be evaluated by a registered nurse and physician prior to discharge home following the&#xD;
      procedure. The patient will be discharged with a responsible adult who will care for the&#xD;
      patient for 24 additional hours. The clinician will communicate with the patient and&#xD;
      responsible adult regarding any adverse side effects. The patient will also receive a phone&#xD;
      number to call to reach the physician or the physician's associate who will be able to&#xD;
      verbally assist the patient immediately should any adverse events occur.&#xD;
&#xD;
      For data collection, one hour following the procedure a clinician will screen for any adverse&#xD;
      side effects and pain will be assessed using a numeric pain scale (0-10). The patient will&#xD;
      also be contacted via telephone to assess adverse side effects and pain scale at 24 hours and&#xD;
      48 hours post procedure. The investigators will also call the patient at 72 to 96 hours to&#xD;
      assess for any adverse effects. The patients will be followed up by the principal&#xD;
      investigator for routine check-ups following the procedure. The clinician will be easily&#xD;
      accessible via telephone and the patient will be given instructions on how to contact the&#xD;
      clinician, if needed.&#xD;
&#xD;
      Data to be collected on each subject will include: date of procedure, specific patient ID,&#xD;
      gender, age, internal hemorrhoids grade, race (White, African American, Hispanic, Asian),&#xD;
      BMI, comorbid conditions, pain 1 hour post procedure, pain 24 and 48 hours post procedure,&#xD;
      requirement of narcotic pain medication, requirement of other oral analgesic medication,&#xD;
      sedation utilized and complications or adverse side effects from the medication.&#xD;
&#xD;
      Upon data collection of this trial, we will monitor for any adverse events. If there is an&#xD;
      adverse event that is deemed by the principal investigator likely due to drug administration,&#xD;
      we will report it to the FDA immediately through written communication and an IND Safety&#xD;
      Report. It will be reported within at least 7 calendar days of being notified of the adverse&#xD;
      event.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 26, 2018</start_date>
  <completion_date type="Actual">June 5, 2020</completion_date>
  <primary_completion_date type="Actual">May 29, 2020</primary_completion_date>
  <phase>Phase 1</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>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Pain following Procedure at 1 hour, 24 hours and 48 hours</measure>
    <time_frame>This information will be collected at 1 hour, 24 hours and 48 hours after the procedure.</time_frame>
    <description>This effect will be measured by statistical analysis comparing the treatment groups numeric pain scale ratings (0-10) with the control groups numeric pain scale ratings (0-10).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Medication Needs</measure>
    <time_frame>This will be evaluated 48 hours after the procedure.</time_frame>
    <description>This effect will be measured by asking the subject what pain medication was needed following the procedure and the amount taken.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Hemorrhoids</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be randomly allocated into the treatment group. The treatment group will receive a 15 mL lidocaine gel enema rectally immediately following completion of the procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients will be randomly allocated into the control group. The control group will not receive a rectal enema.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine Hydrochloride 2% gel enema</intervention_name>
    <description>Insertion of Lidocaine Hydrochloride 2% gel enema rectally immediately following the procedure.</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients older than 18 years of age&#xD;
&#xD;
          -  Patients undergoing endoscopic hemorrhoid band ligation at Advocate Christ Medical&#xD;
             Center&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing endoscopic hemorrhoids band ligation who are already on pain&#xD;
             medications chronically due to other reasons&#xD;
&#xD;
          -  Patients with moderate to severe renal impairment, defined as creatinine greater than&#xD;
             2&#xD;
&#xD;
          -  Patients with hepatic dysfunction, defined as patients with signs or symptoms of liver&#xD;
             dysfunction and/or patients with Childs Pugh Class C&#xD;
&#xD;
          -  Patients with any history of arrhythmias or are currently on anti-arrhythmic&#xD;
             medications&#xD;
&#xD;
          -  Patients with any contraindications to lidocaine, including hypersensitivity to local&#xD;
             anesthetics of the amide type or any other component within the lidocaine 2% jelly&#xD;
&#xD;
          -  Patients with traumatized rectal mucosa in the area of application at the time of the&#xD;
             procedure&#xD;
&#xD;
          -  Patients who are currently pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Advocate Christ Medical Center</name>
      <address>
        <city>Oak Lawn</city>
        <state>Illinois</state>
        <zip>60453</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>November 24, 2020</last_update_submitted>
  <last_update_submitted_qc>November 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhoids</mesh_term>
    <mesh_term>Pain, Procedural</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</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/NCT03797703
org study id: AHC-6999-M5000223
nct id: NCT03797703
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a prospective study to assess the utility of Lidocaine Hydrochloride 2% gel enema
      (Hi-Tech Pharmacal Co., Inc.) in reducing post-procedural pain after endoscopic band ligation
      of internal hemorrhoids. Briefly, patients will be consented prior to entry into the study.
      During the endoscopic band ligation procedure, patients will be blindly placed into the
      treatment arm or control arm. The treatment arm will receive 15 ml enema of lidocaine gel
      immediately upon cessation of the procedure. In the placebo arm, oral pain medications will
      be provided. Researchers will assess pain following the procedure at 1 hour, 24 hours and 48
      hours via telephone call. Another telephone call will be performed at 72 to 96 hours to
      assess any side effects of the medication.
This is a prospective single center study to evaluate side effects and efficacy of a
      lidocaine jelly 2% enema following endoscopic hemorrhoid band ligation. The investigators
      will administer a single dose of 15 mL lidocaine jelly 2%, obtained from Advocate main
      pharmacy, as an enema immediately post procedure. Patients will not be permitted to
      self-administer additional doses following discharge.

      Prior to being enrolled in the study, the clinician will perform a Comprehensive Metabolic
      Panel and Complete Blood Count. When appropriate, a urine pregnancy test will be performed
      prior to enrollment. The investigators will assess for any signs or symptoms of liver
      disease. These assessments will occur within one month of the procedure date. If the patient
      has any signs of renal or hepatic impairment (creatinine greater than 2 or Childs Pugh Class
      3), they will be excluded from the study. The researchers will also exclude patients with any
      history of arrhythmias or who are currently on anti-arrhythmic medications. Once the patient
      is deemed safe to proceed, the lidocaine gel enema will be placed at the cessation of the
      procedure by the investigator. At the time of the procedure, the clinician will assess and
      use their best judgement to determine if the rectal mucosa is generally intact by visual
      inspection. If the mucosa remains intact, the subject will be able to be included in the
      study. However, if the rectal mucosa is traumatized the subject will be excluded and will not
      participate in the randomized treatment.

      Following the procedure, the patient will be monitored closely with a one-on one registered
      nurse for 4 hours in an observation unit. Vital signs will be taken every 5 minutes, as well
      as continuous EKG monitoring and pulse oximetry monitoring. If any adverse side effects
      occur, the physician is immediately available for further management and admission to the
      hospital if needed. Upon completion of the 4-hour observation period, the participants will
      be evaluated by a registered nurse and physician prior to discharge home following the
      procedure. The patient will be discharged with a responsible adult who will care for the
      patient for 24 additional hours. The clinician will communicate with the patient and
      responsible adult regarding any adverse side effects. The patient will also receive a phone
      number to call to reach the physician or the physician's associate who will be able to
      verbally assist the patient immediately should any adverse events occur.

      For data collection, one hour following the procedure a clinician will screen for any adverse
      side effects and pain will be assessed using a numeric pain scale (0-10). The patient will
      also be contacted via telephone to assess adverse side effects and pain scale at 24 hours and
      48 hours post procedure. The investigators will also call the patient at 72 to 96 hours to
      assess for any adverse effects. The patients will be followed up by the principal
      investigator for routine check-ups following the procedure. The clinician will be easily
      accessible via telephone and the patient will be given instructions on how to contact the
      clinician, if needed.

      Data to be collected on each subject will include: date of procedure, specific patient ID,
      gender, age, internal hemorrhoids grade, race (White, African American, Hispanic, Asian),
      BMI, comorbid conditions, pain 1 hour post procedure, pain 24 and 48 hours post procedure,
      requirement of narcotic pain medication, requirement of other oral analgesic medication,
      sedation utilized and complications or adverse side effects from the medication.

      Upon data collection of this trial, we will monitor for any adverse events. If there is an
      adverse event that is deemed by the principal investigator likely due to drug administration,
      we will report it to the FDA immediately through written communication and an IND Safety
      Report. It will be reported within at least 7 calendar days of being notified of the adverse
      event.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Change in Pain following Procedure at 1 hour, 24 hours and 48 hours
time frame: This information will be collected at 1 hour, 24 hours and 48 hours after the procedure.
description: This effect will be measured by statistical analysis comparing the treatment groups numeric pain scale ratings (0-10) with the control groups numeric pain scale ratings (0-10).
measure: Pain Medication Needs
time frame: This will be evaluated 48 hours after the procedure.
description: This effect will be measured by asking the subject what pain medication was needed following the procedure and the amount taken.
arm group label: Treatment
arm group type: Experimental
description: Patients will be randomly allocated into the treatment group. The treatment group will receive a 15 mL lidocaine gel enema rectally immediately following completion of the procedure.
arm group label: Control
arm group type: No Intervention
description: Patients will be randomly allocated into the control group. The control group will not receive a rectal enema.
intervention type: Drug
intervention name: Lidocaine Hydrochloride 2% gel enema
description: Insertion of Lidocaine Hydrochloride 2% gel enema rectally immediately following the procedure.
arm group label: Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hemorrhoids
mesh term: Pain, Procedural
mesh term: Lidocaine
sharing ipd: No