<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/NCT02236585</url>
  </required_header>
  <id_info>
    <org_study_id>UD-2015-16-P2Anesth</org_study_id>
    <secondary_id>GPAnesth-2</secondary_id>
    <nct_id>NCT02236585</nct_id>
  </id_info>
  <brief_title>Patient-Controlled Epidural Analgesia After Uterine Artery Embolization</brief_title>
  <official_title>Does Patient-Controlled Epidural Bupivacaine-Fentanyl Offer Advantages Over Continuous Epidural Infusion After Uterine Arteries Embolization? A Controlled Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Imam Abdulrahman Bin Faisal University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Imam Abdulrahman Bin Faisal University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Uterine artery embolization (UAE) is commonly used to treat symptomatic uterine leiomyomata&#xD;
      through induction of infarction and subsequent hyaline degeneration. This could be followed&#xD;
      with variable severity of pain that lasts for several days after the procedure secondary to&#xD;
      the resulted global uterine ischemia and fibroid infarction. Pain after UAE has been&#xD;
      described as moderate to severe cramping increasing over the first 2 hours after UAE to reach&#xD;
      plateaus for 5 to 8 hours before it rapidly decreases to a much lower level.1 The severity of&#xD;
      pain after UAE seems unrelated to the uterine or fibroid size which makes the severity of&#xD;
      pain is unpredictable.1&#xD;
&#xD;
      Pain management after UAE most often consists of a combination of a non-steroidal&#xD;
      anti-inflammatory drugs, acetaminophen and an opioid. However severe pain following&#xD;
      embolization of the uterine arteries may require large doses of parenteral opioids for relief&#xD;
      with added unwanted effects.2&#xD;
&#xD;
      Additionally, patients received morphine intravenous patient-controlled analgesia (IV-PCA)&#xD;
      after UAE needed considerable amounts of morphine (median [range] 24 mg [0-86 mg]) during the&#xD;
      first 24 h after embolization.3 The addition of ketamine to IV-PCA failed to reduce morphine&#xD;
      consumption for the first 24 hours after UAE. 2&#xD;
&#xD;
      Nowadays, the use of lumbar epidural anesthesia has been standardized as the anesthetic&#xD;
      choice for uterine artery embolization as it improves patients satisfaction and reduces the&#xD;
      severity of post-procedural pain.&#xD;
&#xD;
      Although some investigators suggest an epidural analgesia for pain control after UAE,4 the&#xD;
      use of continuous lumbar epidural infusion of ropivacaine does not improve quality of pain&#xD;
      management after UAE.5&#xD;
&#xD;
      Thus in an observational study included few patients, the investigators demonstrated&#xD;
      considerable postoperative analgesia lasted for 24 hours after UAE with the combined use of&#xD;
      patient-controlled thoracic epidural analgesia (PCEA) and rectal diclofenac.6 However, the&#xD;
      catheterization of thoracic epidural space in such low-risk patients has many logistic&#xD;
      issues.&#xD;
&#xD;
      Up to the best of our knowledge, there is no available comparative randomized clinical trial&#xD;
      compares the use of continuous and patient-controlled lumbar epidural analgesia after UAE.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators hypothesize that the use of a patient-controlled lumbar epidural analgesia&#xD;
      (PCEA) will reduce pain scores and improve patient's satisfaction after uterine artery&#xD;
      embolization.&#xD;
&#xD;
      The present study is aiming to compare the efficacy of PCEA and continuous epidural infusion&#xD;
      of bupivacaine 0.125% with fentanyl 2 µg/ml on the quality of postoperative analgesia after&#xD;
      UAE. Furthermore, the investigators aim to study the correlations between the severity of&#xD;
      pain after UAE and the number and size of uterine leiomyomata.&#xD;
&#xD;
      Following obtaining of the Local Ethics Committee approval and informed patient consent,&#xD;
      sixty patients, aged 18years or older, undergoing routine elective UAE embolization for&#xD;
      uterine leiomyomata under epidural anesthesia will be included in this prospective,&#xD;
      randomized, controlled, double-blind, comparative study.&#xD;
&#xD;
      On the morning before embolization, the patients will be instructed in the use of the PCA&#xD;
      pump and a VAS. The patients will be asked to rate their experienced pain using the VAS from&#xD;
      0 to 100 mm with 0 representing no pain and 100 representing the worst imaginable pain.&#xD;
&#xD;
      Prior to the procedure an 18 to 20 G intravenous access will be established. Patient monitors&#xD;
      includes electrocardiograph, non-invasive blood pressure, peripheral oxygen saturation, and&#xD;
      respiratory rate. All patients will be premedicated with iv midazolam 0.03 mg/kg.&#xD;
&#xD;
      A lumbar epidural catheter (22-G, B. Braun, Germany) will be placed in L2-4 position using&#xD;
      loss of resistance to air and saline on the morning of the procedure. Aspiration and&#xD;
      injection of a 3-mL test dose with 2% lidocaine will be used to exclude accidental&#xD;
      intravascular or subarachnoid catheter position.&#xD;
&#xD;
      Anesthesia technique will be standardized for all women. A loading epidural dose of 20 ml of&#xD;
      0.25% bupivacaine with 2 μg/ml of fentanyl will be administered in divided 5 ml top-up doses.&#xD;
      Epidural catheterization and anesthesia will be done by the attending anesthesiologists who&#xD;
      will not be involved in the postoperative assessment of the patient and who is unaware of the&#xD;
      patient's group.&#xD;
&#xD;
      Femoral artery will be cannulated with a 2.0 mm sheath of the embolization catheters and UAE&#xD;
      will be performed by the same expert interventional radiologist with use of 355-500 μm&#xD;
      polyvinyl alcohol particles (Boston Scientific and Cordis, Natick, MA, USA) suspended in 10&#xD;
      ml of iodixanol 270 mg I/ml (Visipaque; Nycomed Amersham, London, UK) mixed with 20 ml of&#xD;
      isotonic saline. Embolization will be continued until cessation of UAE blood flow occurs.&#xD;
&#xD;
      After the completion of the procedure and decannulation of the femoral artery, the patients&#xD;
      will be randomly allocated into two groups using computer generated randomization codes&#xD;
      included in sealed opaque envelopes&#xD;
&#xD;
      According to our adopted protocol, all patients will receive iv infusion of paracetamol 1 g&#xD;
      every 6 hours and lornoxicam 8 mg every 12 hours. if patients reached a VAS of ≥ 70 mm&#xD;
      despite achieving the maximum preset hourly infusion rates (i.e. 15 ml/hour and 6 ml/hour in&#xD;
      the CEA and PCEA groups, respectively), the protocol allows the attending anesthesiologist,&#xD;
      who will not be involved in collection of patient data, to unlock the pump temporarily to&#xD;
      administer epidural top-up doses of 5 mL of 0.25% bupivacaine plus 2 μg/ml fentanyl every 10&#xD;
      min as required irrespective of the randomization code. If the top-up doses exceeds 25 ml&#xD;
      without pain reduction of ≥ 20 mm, an iv bolus injection of 100 mg tramadol will be given.&#xD;
&#xD;
      At the same time, side effects like as nausea, vomiting, itching, hypotension and bradycardia&#xD;
      will be assessed and recorded. Nausea and vomiting will be treated with iv granisetron 1 mg.&#xD;
      Troublesome pruritus will be treated with chlorpromazine hydrochloride 25 mg im. The patients&#xD;
      will be discharged from the hospital after a one-night stay in the hospital. After discharge,&#xD;
      pain will be controlled with oral lornoxiacam and paracetamol-codeine.&#xD;
&#xD;
      Using retrospective data from our centre in women received the standard continuous epidural&#xD;
      analgesia, a sample size of minimum 30 patients per group was calculated with a study power&#xD;
      of 90% to detect a 20% statistically significant difference in the cumulative consumption of&#xD;
      bupivacaine for 24-hours after UAE.&#xD;
&#xD;
      Data will be expressed as mean ± SD and analysed using Student 't' test, Mann-Whitney U test&#xD;
      and chi square test where appropriate. Linear regression will be performed to define the&#xD;
      correlation between the severity of pain as regarding the VAS and the number and size of&#xD;
      uterine leiomyomata. P &lt; 0.05 will be considered statistically significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Anticipated">June 2019</completion_date>
  <primary_completion_date type="Anticipated">May 2019</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cumulative consumption of bupivacaine-fentanyl</measure>
    <time_frame>24 hours after procedure</time_frame>
    <description>The cumulative consumption of bupivacaine-fentanyl for 24 hours after uterine artery embolization (UAE) will be recorded</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of analgesia</measure>
    <time_frame>every 2 hours intervals after uterine artery embolization</time_frame>
    <description>The patients will be asked to rate their experienced pain using the postoperative pain visual analogue scale (VAS) from 0 to 100 mm with 0 representing no pain and 100 representing the worst imaginable pain, for both parietal and visceral pain during rest and upon coughing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time for first request for rescue analgesia</measure>
    <time_frame>6 hours after surgery</time_frame>
    <description>The time for first request for rescue analgesia (i.e. visual analog scale (VAS) ≥ 50)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of supplementary top-up doses required</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>number of supplementary top-up doses required</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulated amounts of local anesthetic consumption</measure>
    <time_frame>24 hours after procedure</time_frame>
    <description>Cumulated amounts of local anesthetic and tramadol consumption for 24-hours after UAE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall patient satisfaction</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>using 100-mm visual analog scale (VAS) (0 very unsatisfied and 100 very satisfied)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uterine leiomyomata</measure>
    <time_frame>24 hours before uterine artery embolization</time_frame>
    <description>number and size of uterine leiomyomata</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Uterine Artery Embolization for Uterine Leiomyomata</condition>
  <arm_group>
    <arm_group_label>Patient-controlled epidural analgesia</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient-controlled epidural analgesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Continuous epidural analgesia</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Continuous epidural analgesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Patient-controlled epidural analgesia</intervention_name>
    <description>Patients will receive with patient controlled background infusion of 0.125% bupivacaine plus 2 μg/ml fentanyl that will be set between 4-6 ml/hour (to maintain visual analog scale (VAS) of ≥ 50 mm), intermittent bolus of 10 ml on demand by the women with lockout interval of 20 min with a four-hour maximum dose of 100 mL, irrespective of their age. The epidural infusions will be maintained for the first 24 postoperative hours</description>
    <arm_group_label>Patient-controlled epidural analgesia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Continuous epidural analgesia</intervention_name>
    <description>Patients will receive continuous epidural infusion of 0.125% bupivacaine plus 2 μg/ml fentanyl at rate of 6-15 ml/hour (to maintain visual analog scale (VAS) of ≥ 50 mm).</description>
    <arm_group_label>Continuous epidural analgesia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Routine elective uterine artery embolization&#xD;
&#xD;
          -  uterine leiomyomata&#xD;
&#xD;
          -  Epidural anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiac disorder&#xD;
&#xD;
          -  Pulmonary disorder&#xD;
&#xD;
          -  Renal disorder&#xD;
&#xD;
          -  Hepatic disorder&#xD;
&#xD;
          -  Neuropsychiatric disorder&#xD;
&#xD;
          -  Bleeding disorder&#xD;
&#xD;
          -  Severe anatomical abnormalities of the vertebral column&#xD;
&#xD;
          -  Contraindications to epidural analgesia&#xD;
&#xD;
          -  Preoperative pain score &gt; 70 mm&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Daily intake of analgesics&#xD;
&#xD;
          -  Language or mental disorders&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bander F Aldhafery, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chairman of Radiology Dept</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mohamed R El Tahan, MD</last_name>
    <phone>+966 13 865 1193</phone>
    <email>mohamedrefaateltahan@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Abdulmohsin A Al Ghamdi, MD</last_name>
    <phone>+966 50 581 4737</phone>
    <email>mohsenkfu@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>King Fahd Hospital of Dammam University</name>
      <address>
        <city>Khobar</city>
        <state>Eastern</state>
        <zip>31592</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohamed R El Tahan, MD</last_name>
      <phone>+966138966666</phone>
      <phone_ext>2022</phone_ext>
      <email>meltahan@ud.edu.sa</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>King Fahd Hospital of the University</name>
      <address>
        <city>Khobar</city>
        <state>Eastern</state>
        <zip>31952</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Abdulmohsen A Al Ghamdi, MD</last_name>
      <phone>+966 13 8966666</phone>
      <phone_ext>2021</phone_ext>
      <email>mohsenkfu@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Mohamed R El Tahan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Alaa M Khidr, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ahmed G Hassieb, M.Sec</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ahmed Salah, M.Sec.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>May 22, 2018</last_update_submitted>
  <last_update_submitted_qc>May 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>uterine artery embolization, epidural , patient-controlled analgesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leiomyoma</mesh_term>
    <mesh_term>Myofibroma</mesh_term>
  </condition_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/NCT02236585
org study id: UD-2015-16-P2Anesth
secondary id: GPAnesth-2
nct id: NCT02236585
lead sponsor: 
has dmc: Yes
Uterine artery embolization (UAE) is commonly used to treat symptomatic uterine leiomyomata
      through induction of infarction and subsequent hyaline degeneration. This could be followed
      with variable severity of pain that lasts for several days after the procedure secondary to
      the resulted global uterine ischemia and fibroid infarction. Pain after UAE has been
      described as moderate to severe cramping increasing over the first 2 hours after UAE to reach
      plateaus for 5 to 8 hours before it rapidly decreases to a much lower level.1 The severity of
      pain after UAE seems unrelated to the uterine or fibroid size which makes the severity of
      pain is unpredictable.1

      Pain management after UAE most often consists of a combination of a non-steroidal
      anti-inflammatory drugs, acetaminophen and an opioid. However severe pain following
      embolization of the uterine arteries may require large doses of parenteral opioids for relief
      with added unwanted effects.2

      Additionally, patients received morphine intravenous patient-controlled analgesia (IV-PCA)
      after UAE needed considerable amounts of morphine (median [range] 24 mg [0-86 mg]) during the
      first 24 h after embolization.3 The addition of ketamine to IV-PCA failed to reduce morphine
      consumption for the first 24 hours after UAE. 2

      Nowadays, the use of lumbar epidural anesthesia has been standardized as the anesthetic
      choice for uterine artery embolization as it improves patients satisfaction and reduces the
      severity of post-procedural pain.

      Although some investigators suggest an epidural analgesia for pain control after UAE,4 the
      use of continuous lumbar epidural infusion of ropivacaine does not improve quality of pain
      management after UAE.5

      Thus in an observational study included few patients, the investigators demonstrated
      considerable postoperative analgesia lasted for 24 hours after UAE with the combined use of
      patient-controlled thoracic epidural analgesia (PCEA) and rectal diclofenac.6 However, the
      catheterization of thoracic epidural space in such low-risk patients has many logistic
      issues.

      Up to the best of our knowledge, there is no available comparative randomized clinical trial
      compares the use of continuous and patient-controlled lumbar epidural analgesia after UAE.
The investigators hypothesize that the use of a patient-controlled lumbar epidural analgesia
      (PCEA) will reduce pain scores and improve patient's satisfaction after uterine artery
      embolization.

      The present study is aiming to compare the efficacy of PCEA and continuous epidural infusion
      of bupivacaine 0.125% with fentanyl 2 µg/ml on the quality of postoperative analgesia after
      UAE. Furthermore, the investigators aim to study the correlations between the severity of
      pain after UAE and the number and size of uterine leiomyomata.

      Following obtaining of the Local Ethics Committee approval and informed patient consent,
      sixty patients, aged 18years or older, undergoing routine elective UAE embolization for
      uterine leiomyomata under epidural anesthesia will be included in this prospective,
      randomized, controlled, double-blind, comparative study.

      On the morning before embolization, the patients will be instructed in the use of the PCA
      pump and a VAS. The patients will be asked to rate their experienced pain using the VAS from
      0 to 100 mm with 0 representing no pain and 100 representing the worst imaginable pain.

      Prior to the procedure an 18 to 20 G intravenous access will be established. Patient monitors
      includes electrocardiograph, non-invasive blood pressure, peripheral oxygen saturation, and
      respiratory rate. All patients will be premedicated with iv midazolam 0.03 mg/kg.

      A lumbar epidural catheter (22-G, B. Braun, Germany) will be placed in L2-4 position using
      loss of resistance to air and saline on the morning of the procedure. Aspiration and
      injection of a 3-mL test dose with 2% lidocaine will be used to exclude accidental
      intravascular or subarachnoid catheter position.

      Anesthesia technique will be standardized for all women. A loading epidural dose of 20 ml of
      0.25% bupivacaine with 2 μg/ml of fentanyl will be administered in divided 5 ml top-up doses.
      Epidural catheterization and anesthesia will be done by the attending anesthesiologists who
      will not be involved in the postoperative assessment of the patient and who is unaware of the
      patient's group.

      Femoral artery will be cannulated with a 2.0 mm sheath of the embolization catheters and UAE
      will be performed by the same expert interventional radiologist with use of 355-500 μm
      polyvinyl alcohol particles (Boston Scientific and Cordis, Natick, MA, USA) suspended in 10
      ml of iodixanol 270 mg I/ml (Visipaque; Nycomed Amersham, London, UK) mixed with 20 ml of
      isotonic saline. Embolization will be continued until cessation of UAE blood flow occurs.

      After the completion of the procedure and decannulation of the femoral artery, the patients
      will be randomly allocated into two groups using computer generated randomization codes
      included in sealed opaque envelopes

      According to our adopted protocol, all patients will receive iv infusion of paracetamol 1 g
      every 6 hours and lornoxicam 8 mg every 12 hours. if patients reached a VAS of ≥ 70 mm
      despite achieving the maximum preset hourly infusion rates (i.e. 15 ml/hour and 6 ml/hour in
      the CEA and PCEA groups, respectively), the protocol allows the attending anesthesiologist,
      who will not be involved in collection of patient data, to unlock the pump temporarily to
      administer epidural top-up doses of 5 mL of 0.25% bupivacaine plus 2 μg/ml fentanyl every 10
      min as required irrespective of the randomization code. If the top-up doses exceeds 25 ml
      without pain reduction of ≥ 20 mm, an iv bolus injection of 100 mg tramadol will be given.

      At the same time, side effects like as nausea, vomiting, itching, hypotension and bradycardia
      will be assessed and recorded. Nausea and vomiting will be treated with iv granisetron 1 mg.
      Troublesome pruritus will be treated with chlorpromazine hydrochloride 25 mg im. The patients
      will be discharged from the hospital after a one-night stay in the hospital. After discharge,
      pain will be controlled with oral lornoxiacam and paracetamol-codeine.

      Using retrospective data from our centre in women received the standard continuous epidural
      analgesia, a sample size of minimum 30 patients per group was calculated with a study power
      of 90% to detect a 20% statistically significant difference in the cumulative consumption of
      bupivacaine for 24-hours after UAE.

      Data will be expressed as mean ± SD and analysed using Student 't' test, Mann-Whitney U test
      and chi square test where appropriate. Linear regression will be performed to define the
      correlation between the severity of pain as regarding the VAS and the number and size of
      uterine leiomyomata. P < 0.05 will be considered statistically significant.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Cumulative consumption of bupivacaine-fentanyl
time frame: 24 hours after procedure
description: The cumulative consumption of bupivacaine-fentanyl for 24 hours after uterine artery embolization (UAE) will be recorded
measure: Quality of analgesia
time frame: every 2 hours intervals after uterine artery embolization
description: The patients will be asked to rate their experienced pain using the postoperative pain visual analogue scale (VAS) from 0 to 100 mm with 0 representing no pain and 100 representing the worst imaginable pain, for both parietal and visceral pain during rest and upon coughing
measure: Time for first request for rescue analgesia
time frame: 6 hours after surgery
description: The time for first request for rescue analgesia (i.e. visual analog scale (VAS) ≥ 50)
measure: Number of supplementary top-up doses required
time frame: 24 hours after surgery
description: number of supplementary top-up doses required
measure: Cumulated amounts of local anesthetic consumption
time frame: 24 hours after procedure
description: Cumulated amounts of local anesthetic and tramadol consumption for 24-hours after UAE
measure: Overall patient satisfaction
time frame: 24 hours after surgery
description: using 100-mm visual analog scale (VAS) (0 very unsatisfied and 100 very satisfied)
measure: Uterine leiomyomata
time frame: 24 hours before uterine artery embolization
description: number and size of uterine leiomyomata
arm group label: Patient-controlled epidural analgesia
arm group type: Active Comparator
description: Patient-controlled epidural analgesia
arm group label: Continuous epidural analgesia
arm group type: Placebo Comparator
description: Continuous epidural analgesia
intervention type: Procedure
intervention name: Patient-controlled epidural analgesia
description: Patients will receive with patient controlled background infusion of 0.125% bupivacaine plus 2 μg/ml fentanyl that will be set between 4-6 ml/hour (to maintain visual analog scale (VAS) of ≥ 50 mm), intermittent bolus of 10 ml on demand by the women with lockout interval of 20 min with a four-hour maximum dose of 100 mL, irrespective of their age. The epidural infusions will be maintained for the first 24 postoperative hours
arm group label: Patient-controlled epidural analgesia
intervention type: Procedure
intervention name: Continuous epidural analgesia
description: Patients will receive continuous epidural infusion of 0.125% bupivacaine plus 2 μg/ml fentanyl at rate of 6-15 ml/hour (to maintain visual analog scale (VAS) of ≥ 50 mm).
arm group label: Continuous epidural analgesia
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Bander F Aldhafery, MD
role: Principal Investigator
affiliation: Chairman of Radiology Dept
last name: Mohamed R El Tahan, MD
phone: +966 13 865 1193
email: mohamedrefaateltahan@yahoo.com
last name: Abdulmohsin A Al Ghamdi, MD
phone: +966 50 581 4737
email: mohsenkfu@hotmail.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Saudi Arabia
responsible party type: Sponsor
mesh term: Leiomyoma
mesh term: Myofibroma