<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/NCT03239314</url>
  </required_header>
  <id_info>
    <org_study_id>17100210</org_study_id>
    <nct_id>NCT03239314</nct_id>
  </id_info>
  <brief_title>Analgesic Effect of Adductor Canal Block With and Without Dexamethasone for Knee Arthroscopy</brief_title>
  <official_title>The Effect of Adding Dexamethasone to Bupivacaine in Ultrasound Guided Adductor Canal Block for Postoperative Analgesia Following Knee Arthroscopic Anterior Cruciate Ligament Reconstruction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to evaluate the efficacy of ultra-sound guided adductor canal&#xD;
      block with and without dexamethasone when added to bupivacaine on the duration of&#xD;
      postoperative analgesia in patients undergoing arthroscopic anterior cruciate ligament&#xD;
      reconstruction surgery using Numeric Rating Score (NRS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adductor canal block was done by Ultra-sound. After confirmation of the block and exclusion&#xD;
      of any signs of toxicity or nerve injury, the patients operations were done under spinal&#xD;
      anesthesia. Patients were allocated into one of 2 groups (30 patients per group).&#xD;
&#xD;
      I. Group I: the patients received a single-shot of 20 ml plain bupivacaine (0.5%) +2 ml&#xD;
      normal saline.&#xD;
&#xD;
      ii.Group II: the patients received 20ml plain bupivacaine (0.5%) + 8 mg dexamethasone (2ml).&#xD;
&#xD;
      Postoperative pain were assessed by Numeric Rating Scale (N.R.S) every 6 h post-operatively&#xD;
      for 24 h.&#xD;
&#xD;
      Whenever, the NRS Score was ≥4 or the patient requested pain medication, analgesia was&#xD;
      provided by ketorolac 30 mg amp IV, then morphine 1mg ̸ kg slowly IV as a rescue analgesia.&#xD;
      Time to first request for analgesia &amp; total dose of rescue analgesia were be recorded.&#xD;
&#xD;
      10. Satisfaction score will be measured on a linear numerical scale; ranging from 0 =&#xD;
      complete dissatisfaction to 10 = complete satisfaction. Any post-operative side effects, like&#xD;
      nausea, vomiting, bradycardia, hypotension will be also documented. The time to first&#xD;
      analgesic requirement will be recorded, and the cumulative, post-operative opioid consumption&#xD;
      in 24 h post-operatively will be recorded. Assessment of Quadriceps Strength at preoperative,&#xD;
      6, 12, 18, and 24 h postoperative from zero to 5.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">July 22, 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>duration of postoperative analgesia</measure>
    <time_frame>One day postoperative</time_frame>
    <description>assessed by pain score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>postoperative analgesic consumption</measure>
    <time_frame>One day postoperative</time_frame>
    <description>postoperative opioid consumption</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Postoperative Analgesia</condition>
  <arm_group>
    <arm_group_label>group I</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group I (MS): received single shot 20 ml 0.5% isobaric bupivacaine + 2.0 ml normal saline solution injected into the adductor canal preoperatively.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group II</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group II (MD): received 20 ml 0.5% isobaric bupivacaine + 8.0 mg dexamethasone (2.0 ml) injected into adductor canal preoperatively.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline Solution</intervention_name>
    <description>Injected in the adductor canal</description>
    <arm_group_label>group I</arm_group_label>
    <other_name>Normal Saline Solution</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Injected in the adductor canal</description>
    <arm_group_label>group II</arm_group_label>
    <other_name>Decadron</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult ASA I-II Arthroscopic anterior cruciate ligament reconstruction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient refusal&#xD;
&#xD;
          -  drug allergy&#xD;
&#xD;
          -  failed procedure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <results_reference>
    <citation>Rasouli MR, Viscusi ER. Adductor Canal Block for Knee Surgeries: An Emerging Analgesic Technique. Arch Bone Jt Surg. 2017 May;5(3):131-132. No abstract available.</citation>
    <PMID>28656158</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2017</study_first_posted>
  <last_update_submitted>August 3, 2017</last_update_submitted>
  <last_update_submitted_qc>August 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mohamed galal aly</investigator_full_name>
    <investigator_title>Assistant Professor of Anesthesia</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Pharmaceutical Solutions</mesh_term>
  </intervention_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/NCT03239314
org study id: 17100210
nct id: NCT03239314
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this study was to evaluate the efficacy of ultra-sound guided adductor canal
      block with and without dexamethasone when added to bupivacaine on the duration of
      postoperative analgesia in patients undergoing arthroscopic anterior cruciate ligament
      reconstruction surgery using Numeric Rating Score (NRS).
Adductor canal block was done by Ultra-sound. After confirmation of the block and exclusion
      of any signs of toxicity or nerve injury, the patients operations were done under spinal
      anesthesia. Patients were allocated into one of 2 groups (30 patients per group).

      I. Group I: the patients received a single-shot of 20 ml plain bupivacaine (0.5%) +2 ml
      normal saline.

      ii.Group II: the patients received 20ml plain bupivacaine (0.5%) + 8 mg dexamethasone (2ml).

      Postoperative pain were assessed by Numeric Rating Scale (N.R.S) every 6 h post-operatively
      for 24 h.

      Whenever, the NRS Score was ≥4 or the patient requested pain medication, analgesia was
      provided by ketorolac 30 mg amp IV, then morphine 1mg ̸ kg slowly IV as a rescue analgesia.
      Time to first request for analgesia & total dose of rescue analgesia were be recorded.

      10. Satisfaction score will be measured on a linear numerical scale; ranging from 0 =
      complete dissatisfaction to 10 = complete satisfaction. Any post-operative side effects, like
      nausea, vomiting, bradycardia, hypotension will be also documented. The time to first
      analgesic requirement will be recorded, and the cumulative, post-operative opioid consumption
      in 24 h post-operatively will be recorded. Assessment of Quadriceps Strength at preoperative,
      6, 12, 18, and 24 h postoperative from zero to 5.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: duration of postoperative analgesia
time frame: One day postoperative
description: assessed by pain score
measure: postoperative analgesic consumption
time frame: One day postoperative
description: postoperative opioid consumption
arm group label: group I
arm group type: Active Comparator
description: Group I (MS): received single shot 20 ml 0.5% isobaric bupivacaine + 2.0 ml normal saline solution injected into the adductor canal preoperatively.
arm group label: group II
arm group type: Active Comparator
description: Group II (MD): received 20 ml 0.5% isobaric bupivacaine + 8.0 mg dexamethasone (2.0 ml) injected into adductor canal preoperatively.
intervention type: Drug
intervention name: Saline Solution
description: Injected in the adductor canal
arm group label: group I
other name: Normal Saline Solution
intervention type: Drug
intervention name: Dexamethasone
description: Injected in the adductor canal
arm group label: group II
other name: Decadron
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
citation: Rasouli MR, Viscusi ER. Adductor Canal Block for Knee Surgeries: An Emerging Analgesic Technique. Arch Bone Jt Surg. 2017 May;5(3):131-132. No abstract available.
PMID: 28656158
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mohamed galal aly
investigator title: Assistant Professor of Anesthesia
mesh term: Dexamethasone
mesh term: Pharmaceutical Solutions