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/NCT05965674</url>
    </required_header>
    <id_info>
      <org_study_id>KonyaCityH Study Hemo</org_study_id>
      <nct_id>NCT05965674</nct_id>
    </id_info>
    <brief_title>Sacral Erector Spinae Plane Block Effect on Post-Hemorrhoidectomy Pain</brief_title>
    <official_title>The Effect of Sacral Erector Spinae Plane Block on Post-Hemorrhoidectomy Pain</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Konya City Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Konya City Hospital</source>
    <oversight_info>
      <has_dmc>No</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>
        Hemorrhoids are commonly observed surgical conditions affecting the anorectal area,&#xD;
        characterized by symptoms such as pain, bleeding, and the presence of a protruding mass from&#xD;
        the anal opening. Fear of postoperative pain is one of the most important factors for&#xD;
        patients to avoid surgical interventions. Postoperative pain is a significant concern, with&#xD;
        over 80% of patients encountering moderate to severe pain.&#xD;
  &#xD;
        The main aim is to evaluate ESPB from the sacral level would result in effective analgesia&#xD;
        following hemorrhoidectomy. It is also aimed if sacral ESPB would reduce the use of&#xD;
        additional analgesics after hemorrhoidectomy and increase patient satisfaction. In this&#xD;
        prospective, randomized, controlled trial, our main objective was to examine the&#xD;
        postoperative analgesic effects of sacral ESPB following hemorrhoidectomy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Hemorrhoids are commonly observed surgical conditions affecting the anorectal area,&#xD;
        characterized by symptoms such as pain, bleeding, and the presence of a protruding mass from&#xD;
        the anal opening. Fear of postoperative pain is one of the most important factors for&#xD;
        patients to avoid surgical interventions. Postoperative pain is a significant concern, with&#xD;
        over 80% of patients encountering moderate to severe pain. This heightened pain level&#xD;
        contributes to an elevated risk of complications including atelectasis, thromboembolism,&#xD;
        myocardial ischemia, cardiac arrhythmia, electrolyte imbalance, urinary retention, and ileus.&#xD;
        The two main unresolved issues following surgery are postoperative pain and urinary&#xD;
        retention. In addition to improving patient satisfaction, pain management will decrease&#xD;
        urinary retention and constipation, especially in the first 24 hours following surgery.&#xD;
        According to earlier research, even with analgesic therapy, 20% to 40% of patients who&#xD;
        underwent hemorrhoidectomy would experience severe postoperative pain. Commonly used pain&#xD;
        relievers like nonsteroidal anti-inflammatory drugs, paracetamol, and opioids often come with&#xD;
        adverse effects such as dizziness, nausea, vomiting, and constipation and can even lead to&#xD;
        tolerance. These side effects could prevent a full recovery and result in a poor prognosis.&#xD;
        Bilateral pudendal nerve blocks are said to significantly reduce postoperative pain, but they&#xD;
        are technically difficult and require specific positioning. Furthermore, the administration&#xD;
        of pudendal nerve block carries the risk of potential complications, including hematoma&#xD;
        formation, sciatic nerve injury, and accidental rectal puncture. Therefore, an alternative&#xD;
        analgesic method with minimal adverse effects would be beneficial.&#xD;
  &#xD;
        The erector spinae plane block (ESPB) was initially introduced as an interfascial plane block&#xD;
        performed at the upper thoracic levels with the purpose of alleviating neuropathic pain.&#xD;
        Subsequently, its application expanded to encompass a range of thoracic interventions,&#xD;
        including mastectomy, video-assisted thoracoscopy (VATS), and cardiac surgery, while also&#xD;
        being utilized at lumbar levels for procedures such as abdominal surgery, prostatectomy,&#xD;
        lumbar spine surgery, total hip arthroplasty, and proximal femur surgery. A newly introduced&#xD;
        method called the sacral Erector Spinae Plane Block (ESPB) has been recently documented in&#xD;
        scientific literature. Case studies have demonstrated its effectiveness in various surgical&#xD;
        procedures. Specifically, it has shown promise in managing radicular pain at the L5-S1 level&#xD;
        after sex reassignment surgery and hypospadias surgery, as well as providing analgesia for&#xD;
        the posterior branches of the sacral nerves during pilonidal sinus surgery.&#xD;
  &#xD;
        The main hypothesis is that performing ESPB from the sacral level would result in effective&#xD;
        analgesia following hemorrhoidectomy. It is also hypothesized that sacral ESPB would reduce&#xD;
        the use of additional analgesics after hemorrhoidectomy and increase patient satisfaction. In&#xD;
        this prospective, randomized, controlled trial, the main objective is to examine the&#xD;
        postoperative analgesic effects of sacral ESPB following hemorrhoidectomy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 1, 2023</start_date>
    <completion_date type="Actual">July 7, 2023</completion_date>
    <primary_completion_date type="Actual">July 1, 2023</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, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>pain intensity at rest and in motion evaluated with an NRS (0-10, 0 = no pain, 10 = worst pain) at 0, 2, 4, 6, 12, and 24h.</measure>
      <time_frame>Perioperative period</time_frame>
      <description>The primary outcome is pain score at rest and in motion evaluated with an NRS (0-10, 0 = no pain, 10 = worst pain) at 0, 2, 4, 6, 12, and 24h.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The cumulative doses of tramadol, the number of patients who required rescue medication postoperatively, and QoR-15T patient recovery quality.</measure>
      <time_frame>Perioperative period</time_frame>
      <description>The secondary outcome measures are the cumulative doses of tramadol, the number of patients who required rescue medication postoperatively, and QoR-15T patient recovery quality.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">35</enrollment>
    <condition>Postoperative Pain</condition>
    <arm_group>
      <arm_group_label>The sacral ESPB group (Group S)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients in Group S underwent a procedure where a high-frequency linear ultrasound probe (Clarius, 205-2980 Virtual Way, Vancouver, BC, Canada V5M 4X3 MyLabFive; Esaote Europe BV Philipsweg 1 6227 AJ, Maastricht, the Netherlands) was positioned on the transverse plane, specifically on the fifth spinous process. The probe was then moved downwards to visualize the first and second median sacral crest. Next, the transducer was placed 3-4 cm laterally to the second medial sacral crest in order to visualize the intermediate sacral crest. In the interfascial plane, a total of 20 mL of local anesthetic solution (comprised of 10 mL bupivacaine 0.5%, 5 mL lidocaine 2%, and 5 mL normal saline) was injected between the erector spinae muscles and the intermediate sacral crest. The same procedure was performed on the contralateral side.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>The control group (Group N)</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>It will not be performed any extra intervention, just rutin clinic protocol.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Sacral Erector Spinae Plane Block</intervention_name>
      <description>The transducer will be placed 3-4 cm laterally to the second medial sacral crest in order to visualize the intermediate sacral crest. In the interfascial plane, a total of 20 mL of local anesthetic solution (comprised of 10 mL bupivacaine 0.5%, 5 mL lidocaine 2%, and 5 mL normal saline) will be injected between the erector spinae muscles and the intermediate sacral crest. The same procedure will be performed on the contralateral side.</description>
      <arm_group_label>The sacral ESPB group (Group S)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  being between the ages of 18 and 65,&#xD;
  &#xD;
            -  having an ASA status of 1-2.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  under the age of 18, pregnant individuals,&#xD;
  &#xD;
            -  significant hematopoietic, cardiovascular, liver, or kidney disorders,&#xD;
  &#xD;
            -  patients unable to comply with medical instructions, individuals on anticoagulant&#xD;
               therapy, and those with contraindications to regional anesthetic agents or a history&#xD;
               of previous hemorrhoidectomy.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Aydın Mermer</name>
        <address>
          <city>Konya</city>
          <state>Selcuklu</state>
          <zip>42080</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 4, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Konya City Hospital</investigator_affiliation>
      <investigator_full_name>Aydın Mermer</investigator_full_name>
      <investigator_title>Anesthesiologist</investigator_title>
    </responsible_party>
    <keyword>Sacral Erector Spinae Plane Block</keyword>
    <keyword>Post-Hemorrhoidectomy Pain</keyword>
    <keyword>Analgesic consumption</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Postoperative</mesh_term>
    </condition_browse>
    <!-- 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/NCT05965674
  org study id: KonyaCityH Study Hemo
  nct id: NCT05965674
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Hemorrhoids are commonly observed surgical conditions affecting the anorectal area,
        characterized by symptoms such as pain, bleeding, and the presence of a protruding mass from
        the anal opening. Fear of postoperative pain is one of the most important factors for
        patients to avoid surgical interventions. Postoperative pain is a significant concern, with
        over 80% of patients encountering moderate to severe pain.
  
        The main aim is to evaluate ESPB from the sacral level would result in effective analgesia
        following hemorrhoidectomy. It is also aimed if sacral ESPB would reduce the use of
        additional analgesics after hemorrhoidectomy and increase patient satisfaction. In this
        prospective, randomized, controlled trial, our main objective was to examine the
        postoperative analgesic effects of sacral ESPB following hemorrhoidectomy.
  Hemorrhoids are commonly observed surgical conditions affecting the anorectal area,
        characterized by symptoms such as pain, bleeding, and the presence of a protruding mass from
        the anal opening. Fear of postoperative pain is one of the most important factors for
        patients to avoid surgical interventions. Postoperative pain is a significant concern, with
        over 80% of patients encountering moderate to severe pain. This heightened pain level
        contributes to an elevated risk of complications including atelectasis, thromboembolism,
        myocardial ischemia, cardiac arrhythmia, electrolyte imbalance, urinary retention, and ileus.
        The two main unresolved issues following surgery are postoperative pain and urinary
        retention. In addition to improving patient satisfaction, pain management will decrease
        urinary retention and constipation, especially in the first 24 hours following surgery.
        According to earlier research, even with analgesic therapy, 20% to 40% of patients who
        underwent hemorrhoidectomy would experience severe postoperative pain. Commonly used pain
        relievers like nonsteroidal anti-inflammatory drugs, paracetamol, and opioids often come with
        adverse effects such as dizziness, nausea, vomiting, and constipation and can even lead to
        tolerance. These side effects could prevent a full recovery and result in a poor prognosis.
        Bilateral pudendal nerve blocks are said to significantly reduce postoperative pain, but they
        are technically difficult and require specific positioning. Furthermore, the administration
        of pudendal nerve block carries the risk of potential complications, including hematoma
        formation, sciatic nerve injury, and accidental rectal puncture. Therefore, an alternative
        analgesic method with minimal adverse effects would be beneficial.
  
        The erector spinae plane block (ESPB) was initially introduced as an interfascial plane block
        performed at the upper thoracic levels with the purpose of alleviating neuropathic pain.
        Subsequently, its application expanded to encompass a range of thoracic interventions,
        including mastectomy, video-assisted thoracoscopy (VATS), and cardiac surgery, while also
        being utilized at lumbar levels for procedures such as abdominal surgery, prostatectomy,
        lumbar spine surgery, total hip arthroplasty, and proximal femur surgery. A newly introduced
        method called the sacral Erector Spinae Plane Block (ESPB) has been recently documented in
        scientific literature. Case studies have demonstrated its effectiveness in various surgical
        procedures. Specifically, it has shown promise in managing radicular pain at the L5-S1 level
        after sex reassignment surgery and hypospadias surgery, as well as providing analgesia for
        the posterior branches of the sacral nerves during pilonidal sinus surgery.
  
        The main hypothesis is that performing ESPB from the sacral level would result in effective
        analgesia following hemorrhoidectomy. It is also hypothesized that sacral ESPB would reduce
        the use of additional analgesics after hemorrhoidectomy and increase patient satisfaction. In
        this prospective, randomized, controlled trial, the main objective is to examine the
        postoperative analgesic effects of sacral ESPB following hemorrhoidectomy.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: pain intensity at rest and in motion evaluated with an NRS (0-10, 0 = no pain, 10 = worst pain) at 0, 2, 4, 6, 12, and 24h.
  time frame: Perioperative period
  description: The primary outcome is pain score at rest and in motion evaluated with an NRS (0-10, 0 = no pain, 10 = worst pain) at 0, 2, 4, 6, 12, and 24h.
  measure: The cumulative doses of tramadol, the number of patients who required rescue medication postoperatively, and QoR-15T patient recovery quality.
  time frame: Perioperative period
  description: The secondary outcome measures are the cumulative doses of tramadol, the number of patients who required rescue medication postoperatively, and QoR-15T patient recovery quality.
  arm group label: The sacral ESPB group (Group S)
  arm group type: Active Comparator
  description: Patients in Group S underwent a procedure where a high-frequency linear ultrasound probe (Clarius, 205-2980 Virtual Way, Vancouver, BC, Canada V5M 4X3 MyLabFive; Esaote Europe BV Philipsweg 1 6227 AJ, Maastricht, the Netherlands) was positioned on the transverse plane, specifically on the fifth spinous process. The probe was then moved downwards to visualize the first and second median sacral crest. Next, the transducer was placed 3-4 cm laterally to the second medial sacral crest in order to visualize the intermediate sacral crest. In the interfascial plane, a total of 20 mL of local anesthetic solution (comprised of 10 mL bupivacaine 0.5%, 5 mL lidocaine 2%, and 5 mL normal saline) was injected between the erector spinae muscles and the intermediate sacral crest. The same procedure was performed on the contralateral side.
  arm group label: The control group (Group N)
  arm group type: No Intervention
  description: It will not be performed any extra intervention, just rutin clinic protocol.
  intervention type: Procedure
  intervention name: Sacral Erector Spinae Plane Block
  description: The transducer will be placed 3-4 cm laterally to the second medial sacral crest in order to visualize the intermediate sacral crest. In the interfascial plane, a total of 20 mL of local anesthetic solution (comprised of 10 mL bupivacaine 0.5%, 5 mL lidocaine 2%, and 5 mL normal saline) will be injected between the erector spinae muscles and the intermediate sacral crest. The same procedure will be performed on the contralateral side.
  arm group label: The sacral ESPB group (Group S)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Konya City Hospital
  investigator full name: Aydın Mermer
  investigator title: Anesthesiologist
  mesh term: Pain, Postoperative