<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/NCT03789227</url>
  </required_header>
  <id_info>
    <org_study_id>- MFM-IRB ,MD ∕ 16.06.45</org_study_id>
    <nct_id>NCT03789227</nct_id>
  </id_info>
  <brief_title>CT-guided Ablation of the Ganglion Impar for Pelvic Tumors: Comparethe Addition of Ketorolac or Dexamethasone</brief_title>
  <official_title>CT-guided Ethyl Alcohol Ablation of the Ganglion Impar for Pelvic Tumors: Does the Addition of Ketorolac or Dexamethasone Makes a Difference?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</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>
      this study investigator will resaearsh about the efficacy of addition of ketorlac or&#xD;
      dexamethasone to alcohol in ablation of ganglion impar in pelvic tumour to asses thier&#xD;
      efficacy in increasing the intensity or the duration of the block&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to compare the effect of administration of ketorolac versus&#xD;
      dexamethasone on CT guided ganglion impar block with ethyl alcohol in patients with pelvic&#xD;
      tumor.&#xD;
&#xD;
      The primary outcome will be the onset of sensory block, patient satisfaction measured by&#xD;
      patient satisfaction score ( Jones KD, Sutton C., 2003), intensity of pain measured by a&#xD;
      linear visual analogue scale (VAS) (Bourdel, N. et al., 2014) and incidence of early&#xD;
      complications and side effects.&#xD;
&#xD;
      The secondary outcome will include the duration of sensory block, the time and the amount of&#xD;
      post-procedure analgesic requirement, itching and any associated complications.&#xD;
&#xD;
      We hypothesized that CT guided ganglion impar block will be a good choice in pain reduction&#xD;
      in patients with chronic pelvic pain. Pain reduction will be greater in dexamethasone and&#xD;
      ketorolac group compared to alcohol group.Preinterventional assessment includes general, pain&#xD;
      specific history taking (location, quality, intensity, relieving and provoking incidences)&#xD;
      and pain in specific physical examination (inspection and palpation) will be carried out.&#xD;
      Type of pelvic tumor, investigation related to tumor, previous operations, chemotherapy,&#xD;
      basic demographic variables including age, sex and body mass index will be recorded. Routine&#xD;
      investigations include bleeding profiles (bleeding time, clotting time, INR), blood picture,&#xD;
      liver and kidney function tests will be carried out. A linear visual analogue scale (VAS) on&#xD;
      a scale of 0-10 mm (where 0 for no pain and 10 for worst pain) will be explained to each&#xD;
      patient. Written informed consent will be obtained, detailed information on risks and&#xD;
      complications will be provided.The vital signs (heart rate, blood pressure, spo2) will be&#xD;
      recorded. After establishing an access to peripheral venous line, 500 ml normal saline will&#xD;
      be given to the patient, the patient will be in the prone position with a pillow under the&#xD;
      abdomen to allow flexion of the lumbo-sacral spine with internal rotation of the lower&#xD;
      extremities.All patients will be asked to empty the bladder and rectum before the start of&#xD;
      the procedure to facilitate needle placement and avoid inadvertent injection. The&#xD;
      pre-injection planning images will be obtained using CT with 2 mm axial section thickness. A&#xD;
      needle localizer will be placed on the skin surface to identify and mark the sacro-coccygeal&#xD;
      disc.&#xD;
&#xD;
      Sterilization of The patient's sacral and gluteal areas will be provided with povidone iodine&#xD;
      antiseptic solution and this area was circumferentially draped with sterile towels. Under&#xD;
      aseptic technique, a skin wheal will be raised with 2 ml lignocaine 0.5% using 23 G needle&#xD;
      either in midline or paramedian approach. After identifying the ganglion impar, usually at&#xD;
      the level of the sacro-coccygeal disc, a 25 G, 9 cm long spinal needle will be introduced at&#xD;
      approximately 6-9 cm from midline and a small amount of non-ionic contrast medium (0.5 ml&#xD;
      iopamidol; 300 mg/ml) will be injected. The midline approach may be selected according to&#xD;
      patient position and operative condition. In the midline approach the sacro-coccygeal disc is&#xD;
      identified and needle will be introduced perpendicular through the disc and just encroaching&#xD;
      upon presacro-coccygeal space. The patient will be rescanned to confirm the position of the&#xD;
      tip of the spinal needle at the anterior aspect of the sacro-coccygeal junction in the&#xD;
      retroperitoneal space (Datir A and Connell D., 2010).&#xD;
&#xD;
      Thereafter, 3 ml lidocaine 2% will be injected, three minutes later 5 ml absolute alcohol 95%&#xD;
      ± 8 mg dexamethasone or (15 mg ketorolac) will be slowly injected for therapeutic chemical&#xD;
      neurolysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2018</start_date>
  <completion_date type="Actual">October 1, 2019</completion_date>
  <primary_completion_date type="Actual">July 1, 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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the onset of sensory block</measure>
    <time_frame>one week</time_frame>
    <description>occurance of analgesia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>patient satisfaction</measure>
    <time_frame>6 month</time_frame>
    <description>patient satisfaction score ( Jones KD, Sutton C., 2003) by questionnaire for 100</description>
  </primary_outcome>
  <primary_outcome>
    <measure>intensity of pain</measure>
    <time_frame>6 month</time_frame>
    <description>visual analogue scale (VAS) scale from 0 to 10 o no pain 10 maximum pain 0 better 10 worst</description>
  </primary_outcome>
  <primary_outcome>
    <measure>incidence of early complications</measure>
    <time_frame>6 month</time_frame>
    <description>Early complications will be recorded including allergy, bleeding, hematoma, infection, perforation of the rectum and/or bowel, bladder incontinence and nerve root injury. The cauda equine syndrome is another potential complication</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the time and the amount of post-procedure analgesic requirement</measure>
    <time_frame>6 month</time_frame>
    <description>the amount and timing of analgesic consumption and types of analgesics</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Pain, Chronic</condition>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>ganglion impar block :patients will receive a premixed solution of 3 ml lidocaine 2%, 5 ml absolute alcohol 95% and 4 ml saline in a total volume 12 ml.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group D</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ganglion impar block :patients will receive a premixed solution of 3 ml lidocaine 2%, 5 ml absolute alcohol 95% and 8 mg dexamethasone with 4 ml saline in a total volume 12 ml.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group K</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ganglion impar block :patients will receive a premixed solution of 3 ml lidocaine 2%, 5 ml absolute alcohol 95% and 15 mg ketorolac with 4 ml saline in total volume 12 ml.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ganglion impar block</intervention_name>
    <description>the patient will be in the prone position with a pillow under the abdomen The pre-injection planning images will be obtained using CT with 2 mm axial section thickness. Under aseptic technique, a skin wheal will be raised with 2 ml lignocaine 0.5% using 23 G needle either in midline or paramedian approach. After identifying the ganglion impar, usually at the level of the sacro-coccygeal disc, a 25 G, 9 cm long spinal needle will be introduced at approximately 6-9 cm from midline and a small amount of non-ionic contrast medium (0.5 ml iopamidol; 300 mg/ml) will be injected. The midline approach may be selected according to patient position and operative condition. In the midline approach the sacro-coccygeal disc is identified and needle will be introduced perpendicular through the disc and just encroaching upon presacro-coccygeal space. Thereafter, 3 ml lidocaine 2% will be injected, three minutes later 5 ml absolute alcohol 95%.</description>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_label>Group D</arm_group_label>
    <arm_group_label>Group K</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients of either sex aged between 20 to 70 years old with pelvic tumor&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient's refusal.&#xD;
&#xD;
          -  Sever Hepatic and renal impairment.&#xD;
&#xD;
          -  History of allergy to the used drugs.&#xD;
&#xD;
          -  Infection at the area of injection.&#xD;
&#xD;
          -  Coagulopathies.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tarek M. Shams, MD</last_name>
    <role>Study Director</role>
    <affiliation>: Professor of Anesthesia and Surgical Intensive Care</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mansoura university , oncology mansoura university center</name>
      <address>
        <city>Mansourah</city>
        <state>Dakahlia</state>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>December 26, 2018</study_first_submitted>
  <study_first_submitted_qc>December 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>September 2, 2020</last_update_submitted>
  <last_update_submitted_qc>September 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 3, 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>Chronic Pain</mesh_term>
  </condition_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/NCT03789227
org study id: - MFM-IRB ,MD ∕ 16.06.45
nct id: NCT03789227
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
this study investigator will resaearsh about the efficacy of addition of ketorlac or
      dexamethasone to alcohol in ablation of ganglion impar in pelvic tumour to asses thier
      efficacy in increasing the intensity or the duration of the block
The aim of this study is to compare the effect of administration of ketorolac versus
      dexamethasone on CT guided ganglion impar block with ethyl alcohol in patients with pelvic
      tumor.

      The primary outcome will be the onset of sensory block, patient satisfaction measured by
      patient satisfaction score ( Jones KD, Sutton C., 2003), intensity of pain measured by a
      linear visual analogue scale (VAS) (Bourdel, N. et al., 2014) and incidence of early
      complications and side effects.

      The secondary outcome will include the duration of sensory block, the time and the amount of
      post-procedure analgesic requirement, itching and any associated complications.

      We hypothesized that CT guided ganglion impar block will be a good choice in pain reduction
      in patients with chronic pelvic pain. Pain reduction will be greater in dexamethasone and
      ketorolac group compared to alcohol group.Preinterventional assessment includes general, pain
      specific history taking (location, quality, intensity, relieving and provoking incidences)
      and pain in specific physical examination (inspection and palpation) will be carried out.
      Type of pelvic tumor, investigation related to tumor, previous operations, chemotherapy,
      basic demographic variables including age, sex and body mass index will be recorded. Routine
      investigations include bleeding profiles (bleeding time, clotting time, INR), blood picture,
      liver and kidney function tests will be carried out. A linear visual analogue scale (VAS) on
      a scale of 0-10 mm (where 0 for no pain and 10 for worst pain) will be explained to each
      patient. Written informed consent will be obtained, detailed information on risks and
      complications will be provided.The vital signs (heart rate, blood pressure, spo2) will be
      recorded. After establishing an access to peripheral venous line, 500 ml normal saline will
      be given to the patient, the patient will be in the prone position with a pillow under the
      abdomen to allow flexion of the lumbo-sacral spine with internal rotation of the lower
      extremities.All patients will be asked to empty the bladder and rectum before the start of
      the procedure to facilitate needle placement and avoid inadvertent injection. The
      pre-injection planning images will be obtained using CT with 2 mm axial section thickness. A
      needle localizer will be placed on the skin surface to identify and mark the sacro-coccygeal
      disc.

      Sterilization of The patient's sacral and gluteal areas will be provided with povidone iodine
      antiseptic solution and this area was circumferentially draped with sterile towels. Under
      aseptic technique, a skin wheal will be raised with 2 ml lignocaine 0.5% using 23 G needle
      either in midline or paramedian approach. After identifying the ganglion impar, usually at
      the level of the sacro-coccygeal disc, a 25 G, 9 cm long spinal needle will be introduced at
      approximately 6-9 cm from midline and a small amount of non-ionic contrast medium (0.5 ml
      iopamidol; 300 mg/ml) will be injected. The midline approach may be selected according to
      patient position and operative condition. In the midline approach the sacro-coccygeal disc is
      identified and needle will be introduced perpendicular through the disc and just encroaching
      upon presacro-coccygeal space. The patient will be rescanned to confirm the position of the
      tip of the spinal needle at the anterior aspect of the sacro-coccygeal junction in the
      retroperitoneal space (Datir A and Connell D., 2010).

      Thereafter, 3 ml lidocaine 2% will be injected, three minutes later 5 ml absolute alcohol 95%
      ± 8 mg dexamethasone or (15 mg ketorolac) will be slowly injected for therapeutic chemical
      neurolysis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: the onset of sensory block
time frame: one week
description: occurance of analgesia
measure: patient satisfaction
time frame: 6 month
description: patient satisfaction score ( Jones KD, Sutton C., 2003) by questionnaire for 100
measure: intensity of pain
time frame: 6 month
description: visual analogue scale (VAS) scale from 0 to 10 o no pain 10 maximum pain 0 better 10 worst
measure: incidence of early complications
time frame: 6 month
description: Early complications will be recorded including allergy, bleeding, hematoma, infection, perforation of the rectum and/or bowel, bladder incontinence and nerve root injury. The cauda equine syndrome is another potential complication
measure: the time and the amount of post-procedure analgesic requirement
time frame: 6 month
description: the amount and timing of analgesic consumption and types of analgesics
arm group label: Group C
arm group type: Placebo Comparator
description: ganglion impar block :patients will receive a premixed solution of 3 ml lidocaine 2%, 5 ml absolute alcohol 95% and 4 ml saline in a total volume 12 ml.
arm group label: Group D
arm group type: Active Comparator
description: ganglion impar block :patients will receive a premixed solution of 3 ml lidocaine 2%, 5 ml absolute alcohol 95% and 8 mg dexamethasone with 4 ml saline in a total volume 12 ml.
arm group label: Group K
arm group type: Active Comparator
description: ganglion impar block :patients will receive a premixed solution of 3 ml lidocaine 2%, 5 ml absolute alcohol 95% and 15 mg ketorolac with 4 ml saline in total volume 12 ml.
intervention type: Procedure
intervention name: ganglion impar block
description: the patient will be in the prone position with a pillow under the abdomen The pre-injection planning images will be obtained using CT with 2 mm axial section thickness. Under aseptic technique, a skin wheal will be raised with 2 ml lignocaine 0.5% using 23 G needle either in midline or paramedian approach. After identifying the ganglion impar, usually at the level of the sacro-coccygeal disc, a 25 G, 9 cm long spinal needle will be introduced at approximately 6-9 cm from midline and a small amount of non-ionic contrast medium (0.5 ml iopamidol; 300 mg/ml) will be injected. The midline approach may be selected according to patient position and operative condition. In the midline approach the sacro-coccygeal disc is identified and needle will be introduced perpendicular through the disc and just encroaching upon presacro-coccygeal space. Thereafter, 3 ml lidocaine 2% will be injected, three minutes later 5 ml absolute alcohol 95%.
arm group label: Group C
arm group label: Group D
arm group label: Group K
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
last name: Tarek M. Shams, MD
role: Study Director
affiliation: : Professor of Anesthesia and Surgical Intensive Care
facility: 
country: Egypt
responsible party type: Sponsor
mesh term: Chronic Pain
sharing ipd: No