<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/NCT03030950</url>
  </required_header>
  <id_info>
    <org_study_id>N-31-2016</org_study_id>
    <nct_id>NCT03030950</nct_id>
  </id_info>
  <brief_title>Perineural Dexmedetomidine in Adductor Canal Block</brief_title>
  <official_title>Effects of Peri-neural Dexmedetomidine on the Pharmacodynamic Profile of Bupivacaine-induced Adductor Canal Block in Patients Undergoing Arthroscopic Medial Meniscectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo 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 is designed to explore the effects of peri-neural dexmedetomidine on the duration&#xD;
      and motor sparing potentials of adductor canal block in adult patients undergoing&#xD;
      arthroscopic medical meniscectomy in the setting of multimodal analgesia. The investigators&#xD;
      ultimate goal is to increase the postoperative analgesic time and to preserve quadriceps&#xD;
      muscle strength to promote safe and early ambulation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Peripheral nerve blocks using long-acting local anesthetics are commonly utilized as the sole&#xD;
      anesthetic technique or as an adjuvant to general anesthesia for post-operative pain&#xD;
      management. However, the duration of sensory block after single dose of long acting local&#xD;
      anesthetics is not consistently sufficient to avoid the use of postoperative opioids. Many&#xD;
      adjuvants were added to local anesthetics to augment the potency and prolong the duration of&#xD;
      peripheral nerve blocks. Alpha-2 adrenoceptor agonists such as clonidine have been shown to&#xD;
      increase the duration of peripheral nerve block. Dexmedetomidine is a more potent and&#xD;
      selective α-2-adrenoceptor compared to clonidine. Peri-neural dexmedetomidine was evaluated&#xD;
      in animal studies where it prolonged the duration of sensory and motor blocks of local&#xD;
      anesthetics without any evidence of neurotoxicity for up to 14 days after initial&#xD;
      administration. The effectiveness of perineural dexmedetomidine in augmenting the duration of&#xD;
      sensory block of upper limb extremity blocks is based on good quality clinical evidence.&#xD;
&#xD;
      Arthroscopic knee surgery is associated with severe postoperative pain which could be&#xD;
      adequately managed by femoral nerve block. However femoral nerve block has been associated&#xD;
      with significant motor block and decreased quadriceps muscle strength which may delay&#xD;
      ambulation and increase the risk of falling. More recently, adductor canal block (ACB)&#xD;
      emerged as a selective motor sparing effective variant of femoral nerve block. Compared with&#xD;
      baseline values, the adductor canal block reduces quadriceps muscle strength by 8%, versus&#xD;
      49% for the femoral nerve block. A recent dose finding MRI study reported that 20 ml of local&#xD;
      anesthetic is the closest volume to the ED95 for adductor canal block with minimal proximal&#xD;
      spread and an estimated success probability of 95.1% (95% credibility interval: 91-98%).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 25, 2018</start_date>
  <completion_date type="Actual">December 5, 2018</completion_date>
  <primary_completion_date type="Actual">December 1, 2018</primary_completion_date>
  <phase>Phase 4</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>Duration of analgesia</measure>
    <time_frame>24 hours</time_frame>
    <description>the time passed till the patient first analgesic request</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>richmond agitation sedation scale</measure>
    <time_frame>24 hours</time_frame>
    <description>A scale to assess the patient sedation and agitation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>duration of sensory block</measure>
    <time_frame>24 hours</time_frame>
    <description>The time needed to regain the patient sensation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>onset of sensory block</measure>
    <time_frame>minutes</time_frame>
    <description>A blinded investigator will assess sensory block with pinprick test every 5 min for 30 min after injection of the study medication using a 3-point scale: 0 ═ complete loss of sensation, 1 ═ partial loss of sensation and 2 ═ normal sensation. Assessment will be done in comparison to contra-lateral area</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood pressure</measure>
    <time_frame>24 hours</time_frame>
    <description>mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>heart rate</measure>
    <time_frame>24 hours</time_frame>
    <description>beat per minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>onset of motor block (by assessment of quadriceps muscle strength)</measure>
    <time_frame>minutes</time_frame>
    <description>The maximum voluntary isometric contraction (MVIC) of the quadriceps femoris muscle will be measured using a handheld dynamometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>resting visual analogue score</measure>
    <time_frame>24 hours</time_frame>
    <description>the grade of pain during rest as experienced by the patient, rated from 0 to 10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>dynamic visual analogue score</measure>
    <time_frame>24 hours</time_frame>
    <description>the grade of pain with movement as experienced by the patient, rated from 0 to 10</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Arthroscopic Medial Meniscectomy</condition>
  <arm_group>
    <arm_group_label>Dexmedetomidine group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adductor canal block will be performed before induction of general anesthesia. Patients will be positioned in the supine position with knee slightly flexed and leg externally rotated followed by ultrasound scanning of the middle of thigh using 13-6 MHz linear array probe. The ultrasound probe will be placed over the anterior aspect of the patient's thigh, mid-point between the inguinal crease and medial femoral condyle. The scan will be focused on the femoral artery pulsations aiming to try to visualize the nerves in the adductor canal on both sides (lateral and medial) of the pulsating femoral artery. 20 ml bupivacaine 0.25% combined with 75 mcg dexmedetomidine will be injected. The study solution will be injected underneath the fascia of sartorius muscle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Adductor canal block will be performed before induction of general anesthesia. Patients will be positioned in the supine position with knee slightly flexed and leg externally rotated followed by ultrasound scanning of the middle of thigh using 13-6 MHz linear array probe. The ultrasound probe will be placed over the anterior aspect of the patient's thigh, mid-point between the inguinal crease and medial femoral condyle. The scan will be focused on the femoral artery pulsations aiming to try to visualize the nerves in the adductor canal on both sides (lateral and medial) of the pulsating femoral artery. 20 ml bupivacaine 0.25% combined with 75 mcg dexmedetomidine will be injected. The study solution will be injected underneath the fascia of sartorius muscle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>to investigate the effect of dexmedetomidine on motor and sensory properties of adductor canal block</description>
    <arm_group_label>Dexmedetomidine group</arm_group_label>
    <other_name>Precedex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <description>to give normal saline to the other group as a placebo</description>
    <arm_group_label>Control group</arm_group_label>
    <other_name>Saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients of aged (18-45), ASA physical status I or II undergoing arthroscopic&#xD;
             medial meniscectomy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Body mass index greater than 35 kg/m2.&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Unstable coronary artery disease, congestive heart failure, or arrhythmias.&#xD;
&#xD;
          -  Baseline heart rate (HR) less than 60 beats/min or baseline systolic blood pressure&#xD;
             less than 100 mmHg.&#xD;
&#xD;
          -  Pre-existing neurological deficits or neuropathy.&#xD;
&#xD;
          -  Significant psychiatric or cognitive conditions interfering with consent or&#xD;
             assessment.&#xD;
&#xD;
          -  Significant renal or hepatic impairment;&#xD;
&#xD;
          -  Severe bronchopulmonary disease, including chronic obstructive pulmonary disease and&#xD;
             obstructive sleep apnea.&#xD;
&#xD;
          -  Known contraindications to peripheral nerve block, including local skin infections,&#xD;
             bleeding diathesis, and coagulopathy.&#xD;
&#xD;
          -  Allergies to local anesthetics, dexmedetomidine, or any component of multimodal&#xD;
             analgesia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohamed Abdulatif, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Professor and member of research committee of anesthesia department</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cairo University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>January 13, 2019</last_update_submitted>
  <last_update_submitted_qc>January 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed Hasanin</investigator_full_name>
    <investigator_title>Lecturer of anesthesia and critical care medicine</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</mesh_term>
  </intervention_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/NCT03030950
org study id: N-31-2016
nct id: NCT03030950
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is designed to explore the effects of peri-neural dexmedetomidine on the duration
      and motor sparing potentials of adductor canal block in adult patients undergoing
      arthroscopic medical meniscectomy in the setting of multimodal analgesia. The investigators
      ultimate goal is to increase the postoperative analgesic time and to preserve quadriceps
      muscle strength to promote safe and early ambulation.
Peripheral nerve blocks using long-acting local anesthetics are commonly utilized as the sole
      anesthetic technique or as an adjuvant to general anesthesia for post-operative pain
      management. However, the duration of sensory block after single dose of long acting local
      anesthetics is not consistently sufficient to avoid the use of postoperative opioids. Many
      adjuvants were added to local anesthetics to augment the potency and prolong the duration of
      peripheral nerve blocks. Alpha-2 adrenoceptor agonists such as clonidine have been shown to
      increase the duration of peripheral nerve block. Dexmedetomidine is a more potent and
      selective α-2-adrenoceptor compared to clonidine. Peri-neural dexmedetomidine was evaluated
      in animal studies where it prolonged the duration of sensory and motor blocks of local
      anesthetics without any evidence of neurotoxicity for up to 14 days after initial
      administration. The effectiveness of perineural dexmedetomidine in augmenting the duration of
      sensory block of upper limb extremity blocks is based on good quality clinical evidence.

      Arthroscopic knee surgery is associated with severe postoperative pain which could be
      adequately managed by femoral nerve block. However femoral nerve block has been associated
      with significant motor block and decreased quadriceps muscle strength which may delay
      ambulation and increase the risk of falling. More recently, adductor canal block (ACB)
      emerged as a selective motor sparing effective variant of femoral nerve block. Compared with
      baseline values, the adductor canal block reduces quadriceps muscle strength by 8%, versus
      49% for the femoral nerve block. A recent dose finding MRI study reported that 20 ml of local
      anesthetic is the closest volume to the ED95 for adductor canal block with minimal proximal
      spread and an estimated success probability of 95.1% (95% credibility interval: 91-98%).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Duration of analgesia
time frame: 24 hours
description: the time passed till the patient first analgesic request
measure: richmond agitation sedation scale
time frame: 24 hours
description: A scale to assess the patient sedation and agitation
measure: duration of sensory block
time frame: 24 hours
description: The time needed to regain the patient sensation
measure: onset of sensory block
time frame: minutes
description: A blinded investigator will assess sensory block with pinprick test every 5 min for 30 min after injection of the study medication using a 3-point scale: 0 ═ complete loss of sensation, 1 ═ partial loss of sensation and 2 ═ normal sensation. Assessment will be done in comparison to contra-lateral area
measure: blood pressure
time frame: 24 hours
description: mmHg
measure: heart rate
time frame: 24 hours
description: beat per minutes
measure: onset of motor block (by assessment of quadriceps muscle strength)
time frame: minutes
description: The maximum voluntary isometric contraction (MVIC) of the quadriceps femoris muscle will be measured using a handheld dynamometer
measure: resting visual analogue score
time frame: 24 hours
description: the grade of pain during rest as experienced by the patient, rated from 0 to 10
measure: dynamic visual analogue score
time frame: 24 hours
description: the grade of pain with movement as experienced by the patient, rated from 0 to 10
arm group label: Dexmedetomidine group
arm group type: Experimental
description: Adductor canal block will be performed before induction of general anesthesia. Patients will be positioned in the supine position with knee slightly flexed and leg externally rotated followed by ultrasound scanning of the middle of thigh using 13-6 MHz linear array probe. The ultrasound probe will be placed over the anterior aspect of the patient's thigh, mid-point between the inguinal crease and medial femoral condyle. The scan will be focused on the femoral artery pulsations aiming to try to visualize the nerves in the adductor canal on both sides (lateral and medial) of the pulsating femoral artery. 20 ml bupivacaine 0.25% combined with 75 mcg dexmedetomidine will be injected. The study solution will be injected underneath the fascia of sartorius muscle.
arm group label: Control group
arm group type: Placebo Comparator
description: Adductor canal block will be performed before induction of general anesthesia. Patients will be positioned in the supine position with knee slightly flexed and leg externally rotated followed by ultrasound scanning of the middle of thigh using 13-6 MHz linear array probe. The ultrasound probe will be placed over the anterior aspect of the patient's thigh, mid-point between the inguinal crease and medial femoral condyle. The scan will be focused on the femoral artery pulsations aiming to try to visualize the nerves in the adductor canal on both sides (lateral and medial) of the pulsating femoral artery. 20 ml bupivacaine 0.25% combined with 75 mcg dexmedetomidine will be injected. The study solution will be injected underneath the fascia of sartorius muscle.
intervention type: Drug
intervention name: Dexmedetomidine
description: to investigate the effect of dexmedetomidine on motor and sensory properties of adductor canal block
arm group label: Dexmedetomidine group
other name: Precedex
intervention type: Drug
intervention name: Normal saline
description: to give normal saline to the other group as a placebo
arm group label: Control group
other name: Saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Mohamed Abdulatif, Professor
role: Study Director
affiliation: Professor and member of research committee of anesthesia department
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed Hasanin
investigator title: Lecturer of anesthesia and critical care medicine
mesh term: Dexmedetomidine
sharing ipd: No