xml: <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/NCT05990868</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY005325</org_study_id>
      <nct_id>NCT05990868</nct_id>
    </id_info>
    <brief_title>Rectal Acetaminophen During Oocyte Retrievals</brief_title>
    <official_title>Administration of Rectal Acetaminophen During Oocyte Retrievals Reduces Post-Operative Opioid Utilization in Fertility Patients.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of South Florida</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of South Florida</source>
    <oversight_info>
      <has_dmc>Yes</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>
        As the opioid epidemic shows no sign of abating, this national crisis deserves careful&#xD;
        attention from all medical subspecialties. This includes reproductive endocrinology and&#xD;
        infertility (REI), where opioids are primarily utilized for intraoperative and postoperative&#xD;
        pain management for outpatient procedures such as oocyte retrievals, operative hysteroscopy,&#xD;
        and laparoscopic myomectomy. The primary aim of this study is to evaluate whether or not the&#xD;
        administration of rectal acetaminophen as an alternative analgesic at the completion of&#xD;
        oocyte retrieval would reduce postoperative utilization of opioids (Tylenol with oxycodone)&#xD;
        in fertility patients. This trial has the potential to provide practice-changing clinical&#xD;
        information to the field of REI. The information gained can even translate to other&#xD;
        ambulatory procedures and guide clinical practice.&#xD;
  &#xD;
        Primary objective of the study will be to identify the proportion of prescribed Acetaminophen&#xD;
        and Narcotics utilized 3 days following oocyte retrieval.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        There are various methods of anesthesia used for transvaginal ultrasound guided oocyte&#xD;
        retrievals. The majority of cases are performed under conscious sedation with a combination&#xD;
        of sedative-hypnotic agents and analgesics while a small proportion of these retrievals are&#xD;
        performed under general, regional, or local anesthesia. Conscious sedation is defined as, &quot;a&#xD;
        minimally depressed level of consciousness that retains the patient's ability to maintain a&#xD;
        patent airway independently and continuously and to respond appropriately to physical&#xD;
        stimulation and verbal commands.&quot;1 The most common agents chosen for conscious sedation are&#xD;
        midazolam and/or Propofol with fentanyl for analgesia in some cases. One retrospective study&#xD;
        looking at over a thousand patients undergoing oocyte retrieval at an in vitro fertilization&#xD;
        (IVF) center found that no complications developed relating to anesthesia. Several&#xD;
        cross-sectional studies looking at patients undergoing ultrasound-guided transvaginal&#xD;
        follicle aspiration found that there was high patient satisfaction with a conscious sedation&#xD;
        protocol of midazolam and opioid analgesia. Although this technique of conscious sedation has&#xD;
        been the standard of care for several decades demonstrating good patient satisfaction and&#xD;
        complications are rare, patients are still given oral opioids for postoperative pain. Given&#xD;
        current opioid addiction crisis, it is prudent to challenge current practice by evaluating&#xD;
        possible interventions that could help reduce both intraoperative and postoperative&#xD;
        administration of opioids to fertility patients.&#xD;
  &#xD;
        The pain experienced in oocyte retrieval is caused by the needle puncturing through the&#xD;
        vaginal wall and by the mechanical stimulation of the ovary. This pain is often described as&#xD;
        similar to intense menstrual cramping4. The retrospective study referenced above evaluated&#xD;
        patients' self-reported degrees of pain and found that over 80% of patients undergoing oocyte&#xD;
        retrieval reported having only mild pain or no pain at all5. Another study found that 6.9% of&#xD;
        patients undergoing oocyte retrieval reported the procedure to be very or extremely painful&#xD;
        with significant predictors of pain being negative gynecological experiences, having&#xD;
        experienced side effects during their hormonal treatment, higher levels of intraoperative&#xD;
        anxiety, lower levels of perceived control, and longer duration of the retrieval procedure.&#xD;
  &#xD;
        Given that most patients seem to tolerate the procedure well, this is a potential clinical&#xD;
        area in which opioid use could be minimized, or even eliminated, and non-opioid analgesia&#xD;
        could be employed instead.&#xD;
  &#xD;
        The current opioid addiction epidemic is one that has been called the &quot;most consequential&#xD;
        preventable public health problem in the United States.&quot; Although the in-vitro fertilization&#xD;
        demographic is not typically associated with substance abuse, it is thought that about six&#xD;
        percent of opioid naïve patients are at an increased risk for abusing the medication after&#xD;
        surgery and developing new persistent opioid use after being prescribed opioids after an&#xD;
        elective surgical procedure. In a study by Bortelleto et al it was reported that&#xD;
        approximately 12 % of women fill up opioid prescription after oocyte retrieval8. In a recent&#xD;
        study by Petrozza et al evaluated use of IV Acetaminophen in oocyte retrieval and reported&#xD;
        that preoperative IV acetaminophen did not reduce postoperative pain scores or shorten the&#xD;
        time to discharge when compared with PO acetaminophen or placebo and, thus, cannot currently&#xD;
        be recommended routinely in this patient population. Thus, the purpose of this study is to&#xD;
        evaluate whether intra-procedure administration of rectal Acetaminophen would be sufficient&#xD;
        to manage postoperative pain after oocyte retrievals and could help decrease utilization of&#xD;
        prescribed opioid at home following oocyte retrieval.&#xD;
  &#xD;
        The primary outcome of this study is to determine the proportion of prescribed Acetaminophen&#xD;
        and Opioids (oxycodone) used for the management of pain 3 days after egg retrieval.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">August 2025</completion_date>
    <primary_completion_date type="Anticipated">August 2024</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>The primary outcome in this study is the proportion of the prescribed medications used three days after discharge from the surgery. Assuming that only one third or less of the Narcotics prescribed (2 out of 6 tablets) in Group 1 will be utilized as compared to two thirds or more (4 out of 6 tables) in group 2, 35 patients in each group will be required to achieve 80% power and two-sided level of significance of 0.058. Given we expect possible 10% drop out rate after randomization, we plan to recruit 39 patients in each group (78 total sample). We plan to perform our analysis using SPSS.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Care Provider)</masking>
      <masking_description>Both patient and provider will be blinded to the intervention.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Evaluate reduction in opioid use post oocyte retrieval</measure>
      <time_frame>1 year</time_frame>
      <description>to determine the proportion of prescribed Acetaminophen and Opioids (oxycodone) used for the management of pain 3 days after egg retrieval.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">78</enrollment>
    <condition>Oocyte Retrieival and Post Operative Pain Control</condition>
    <arm_group>
      <arm_group_label>Rectal tylenol group: Group 1</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Randomization to the study group (Group 1): will receive standard anesthesia and 650 mg rectal Tylenol at the time of egg retrieval.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo group: Group 2</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Randomization to the standard of care group (Group 2): will receive standard anesthesia and rectal placebo at the time of oocyte retrieval. Placebo is a substance that has no therapeutic effect and used as a control in testing new drugs.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Tylenol</intervention_name>
      <description>Rectal tylenol will be placed at the time of oocyte retrieval</description>
      <arm_group_label>Placebo group: Group 2</arm_group_label>
      <arm_group_label>Rectal tylenol group: Group 1</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria: Any female patient undergoing oocyte retrieval by transvaginal&#xD;
          ultrasound-guided ovarian puncture.&#xD;
  &#xD;
          -&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with chronic pain conditions such as fibromyalgia and sickle cell anemia.&#xD;
  &#xD;
            2. Patient with BMI greater than 40&#xD;
  &#xD;
            3. Patients undergoing transabdominal ultrasound guided oocyte retrieval&#xD;
  &#xD;
            4. Patients that required general endotracheal intubation anesthesia in prior oocyte&#xD;
               retrieval.&#xD;
  &#xD;
            5. Patients with documented allergic reaction to acetaminophen or oxycodone&#xD;
  &#xD;
            6. Patient with contra-indication to the use of acetaminophen (liver disease)&#xD;
  &#xD;
            7. Patients with a history of past or current alcohol, drug or opioid abuse.&#xD;
  &#xD;
            8. Patients with ulcerative colitis, Crohn's disease, or severe rectal hemorrhoids.&#xD;
  &#xD;
            9. Patients who develop complication such as PID post procedure.&#xD;
  &#xD;
               -&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Only females can undergo oocyte retrieval as they are the gender with ovaries. Our study involves oocyte retrieval procedure.</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 6, 2023</last_update_submitted>
    <last_update_submitted_qc>August 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of South Florida</investigator_affiliation>
      <investigator_full_name>Anthony Imudia</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Postoperative</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Acetaminophen</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05990868
  org study id: STUDY005325
  nct id: NCT05990868
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  As the opioid epidemic shows no sign of abating, this national crisis deserves careful
        attention from all medical subspecialties. This includes reproductive endocrinology and
        infertility (REI), where opioids are primarily utilized for intraoperative and postoperative
        pain management for outpatient procedures such as oocyte retrievals, operative hysteroscopy,
        and laparoscopic myomectomy. The primary aim of this study is to evaluate whether or not the
        administration of rectal acetaminophen as an alternative analgesic at the completion of
        oocyte retrieval would reduce postoperative utilization of opioids (Tylenol with oxycodone)
        in fertility patients. This trial has the potential to provide practice-changing clinical
        information to the field of REI. The information gained can even translate to other
        ambulatory procedures and guide clinical practice.
  
        Primary objective of the study will be to identify the proportion of prescribed Acetaminophen
        and Narcotics utilized 3 days following oocyte retrieval.
  There are various methods of anesthesia used for transvaginal ultrasound guided oocyte
        retrievals. The majority of cases are performed under conscious sedation with a combination
        of sedative-hypnotic agents and analgesics while a small proportion of these retrievals are
        performed under general, regional, or local anesthesia. Conscious sedation is defined as, "a
        minimally depressed level of consciousness that retains the patient's ability to maintain a
        patent airway independently and continuously and to respond appropriately to physical
        stimulation and verbal commands."1 The most common agents chosen for conscious sedation are
        midazolam and/or Propofol with fentanyl for analgesia in some cases. One retrospective study
        looking at over a thousand patients undergoing oocyte retrieval at an in vitro fertilization
        (IVF) center found that no complications developed relating to anesthesia. Several
        cross-sectional studies looking at patients undergoing ultrasound-guided transvaginal
        follicle aspiration found that there was high patient satisfaction with a conscious sedation
        protocol of midazolam and opioid analgesia. Although this technique of conscious sedation has
        been the standard of care for several decades demonstrating good patient satisfaction and
        complications are rare, patients are still given oral opioids for postoperative pain. Given
        current opioid addiction crisis, it is prudent to challenge current practice by evaluating
        possible interventions that could help reduce both intraoperative and postoperative
        administration of opioids to fertility patients.
  
        The pain experienced in oocyte retrieval is caused by the needle puncturing through the
        vaginal wall and by the mechanical stimulation of the ovary. This pain is often described as
        similar to intense menstrual cramping4. The retrospective study referenced above evaluated
        patients' self-reported degrees of pain and found that over 80% of patients undergoing oocyte
        retrieval reported having only mild pain or no pain at all5. Another study found that 6.9% of
        patients undergoing oocyte retrieval reported the procedure to be very or extremely painful
        with significant predictors of pain being negative gynecological experiences, having
        experienced side effects during their hormonal treatment, higher levels of intraoperative
        anxiety, lower levels of perceived control, and longer duration of the retrieval procedure.
  
        Given that most patients seem to tolerate the procedure well, this is a potential clinical
        area in which opioid use could be minimized, or even eliminated, and non-opioid analgesia
        could be employed instead.
  
        The current opioid addiction epidemic is one that has been called the "most consequential
        preventable public health problem in the United States." Although the in-vitro fertilization
        demographic is not typically associated with substance abuse, it is thought that about six
        percent of opioid naïve patients are at an increased risk for abusing the medication after
        surgery and developing new persistent opioid use after being prescribed opioids after an
        elective surgical procedure. In a study by Bortelleto et al it was reported that
        approximately 12 % of women fill up opioid prescription after oocyte retrieval8. In a recent
        study by Petrozza et al evaluated use of IV Acetaminophen in oocyte retrieval and reported
        that preoperative IV acetaminophen did not reduce postoperative pain scores or shorten the
        time to discharge when compared with PO acetaminophen or placebo and, thus, cannot currently
        be recommended routinely in this patient population. Thus, the purpose of this study is to
        evaluate whether intra-procedure administration of rectal Acetaminophen would be sufficient
        to manage postoperative pain after oocyte retrievals and could help decrease utilization of
        prescribed opioid at home following oocyte retrieval.
  
        The primary outcome of this study is to determine the proportion of prescribed Acetaminophen
        and Opioids (oxycodone) used for the management of pain 3 days after egg retrieval.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The primary outcome in this study is the proportion of the prescribed medications used three days after discharge from the surgery. Assuming that only one third or less of the Narcotics prescribed (2 out of 6 tablets) in Group 1 will be utilized as compared to two thirds or more (4 out of 6 tables) in group 2, 35 patients in each group will be required to achieve 80% power and two-sided level of significance of 0.058. Given we expect possible 10% drop out rate after randomization, we plan to recruit 39 patients in each group (78 total sample). We plan to perform our analysis using SPSS.
  primary purpose: Treatment
  masking: Double (Participant, Care Provider)
  masking description: Both patient and provider will be blinded to the intervention.
  measure: Evaluate reduction in opioid use post oocyte retrieval
  time frame: 1 year
  description: to determine the proportion of prescribed Acetaminophen and Opioids (oxycodone) used for the management of pain 3 days after egg retrieval.
  arm group label: Rectal tylenol group: Group 1
  arm group type: Active Comparator
  description: Randomization to the study group (Group 1): will receive standard anesthesia and 650 mg rectal Tylenol at the time of egg retrieval.
  arm group label: Placebo group: Group 2
  arm group type: Placebo Comparator
  description: Randomization to the standard of care group (Group 2): will receive standard anesthesia and rectal placebo at the time of oocyte retrieval. Placebo is a substance that has no therapeutic effect and used as a control in testing new drugs.
  intervention type: Drug
  intervention name: Tylenol
  description: Rectal tylenol will be placed at the time of oocyte retrieval
  arm group label: Placebo group: Group 2
  arm group label: Rectal tylenol group: Group 1
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Only females can undergo oocyte retrieval as they are the gender with ovaries. Our study involves oocyte retrieval procedure.
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: University of South Florida
  investigator full name: Anthony Imudia
  investigator title: Associate Professor
  mesh term: Pain, Postoperative
  mesh term: Acetaminophen
  sharing ipd: Undecided