<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/NCT03248648</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00008788</org_study_id>
    <nct_id>NCT03248648</nct_id>
  </id_info>
  <brief_title>Efficacy of Intra-articular Neostigmine Versus Ketamine for Postoperative Analgesia in Arthroscopic Knee Surgery</brief_title>
  <official_title>Efficacy of Intra-articular Neostigmine Versus Ketamine for Postoperative Analgesia in Arthroscopic Knee Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ghada Mohammed AboelFadl</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Abualauon Elbiblawy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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>
      To compare the efficacy of intra-articular administration of neostigmine versus ketamine as&#xD;
      adjuvant analgesics after knee arthroscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Arthroscopic knee surgery is commonly performed as an outpatient procedure and is often&#xD;
      associated with postoperative pain. Intraarticular (IA) local anesthetics (LA) are often used&#xD;
      for prevention of pain after arthroscopic knee surgery; however, the degree of postoperative&#xD;
      pain varies. In an effort to find the ideal regime for sufficient, long-lasting postoperative&#xD;
      analgesia, many different drugs, including opioids, nonsteroidal anti-inflammatory drugs,&#xD;
      ketamine, clonidine, and neostigmine, have been added to the IA LAs The investigators&#xD;
      designed this study to compare the efficacy of intra-articular administration of neostigmine&#xD;
      versus ketamine as adjuvant analgesics after knee arthroscopy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">December 1, 2017</completion_date>
  <primary_completion_date type="Actual">September 1, 2017</primary_completion_date>
  <phase>Phase 2/Phase 3</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>
    <masking_description>Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative analgesic consumption</measure>
    <time_frame>36 hours postoperative the total consumption of analgesics in the first 36h postoperative</time_frame>
    <description>assessment of each patient on his bed at inpatient ward every 4 hours over a 36-hour period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative visual analogue pain scale (VAS)</measure>
    <time_frame>36 hours postoperative</time_frame>
    <description>assessment of each patient on his bed at inpatient ward every 4 hours over a 36-hour period</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>Neostigmine group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>At the end of the surgery patients receive 0.5mg/dose neostigmine +18ml 0.25%bupivacaine in a total volume of 20 ml.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ketamine group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>At the end of the surgery patients receive 0.5 mg/kg ketamine+18ml 0.25%bupivacaine in a total volume of 20 ml.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Neostigmine</intervention_name>
    <description>patient receive 0.5mg/dose neostigmine +18ml 0.25%bupivacaine in a total volume of 20 ml.</description>
    <arm_group_label>Neostigmine group</arm_group_label>
    <other_name>epistigmine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ketamine</intervention_name>
    <description>patient receive 0.5 mg/kg ketamine+18ml 0.25%bupivacaine in a total volume of 20 ml.</description>
    <arm_group_label>ketamine group</arm_group_label>
    <other_name>Ketalar</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  One hundred patients aged above 18-50 years (ASA I or II) scheduled for elective&#xD;
             arthroscopic knee surgery under intrathecal anaesthesia will be enrolled in our study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Absolute or relative contraindications for intrathecal anaesthesia,&#xD;
&#xD;
          -  Allergy for the studied drugs.&#xD;
&#xD;
          -  Patients having history of cardiovascular, cerebrovascular, and respiratory diseases,&#xD;
&#xD;
          -  Patients receiving chronic pain treatment or hypertension treated with α methyldopa,&#xD;
             clonidine or β adrenergic blockers were excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Abualauon Elbiplaoy, lectural of anesthesia</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assiut university hospitals</name>
      <address>
        <city>Assiut</city>
        <state>Assiut Governorate</state>
        <zip>Egypt, 715715</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>January 12, 2019</last_update_submitted>
  <last_update_submitted_qc>January 12, 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>Assiut University</investigator_affiliation>
    <investigator_full_name>Amani Hassan Abdel-Wahab</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ketamine</mesh_term>
    <mesh_term>Neostigmine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03248648
org study id: IRB00008788
nct id: NCT03248648
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
To compare the efficacy of intra-articular administration of neostigmine versus ketamine as
      adjuvant analgesics after knee arthroscopy.
Arthroscopic knee surgery is commonly performed as an outpatient procedure and is often
      associated with postoperative pain. Intraarticular (IA) local anesthetics (LA) are often used
      for prevention of pain after arthroscopic knee surgery; however, the degree of postoperative
      pain varies. In an effort to find the ideal regime for sufficient, long-lasting postoperative
      analgesia, many different drugs, including opioids, nonsteroidal anti-inflammatory drugs,
      ketamine, clonidine, and neostigmine, have been added to the IA LAs The investigators
      designed this study to compare the efficacy of intra-articular administration of neostigmine
      versus ketamine as adjuvant analgesics after knee arthroscopy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
measure: postoperative analgesic consumption
time frame: 36 hours postoperative the total consumption of analgesics in the first 36h postoperative
description: assessment of each patient on his bed at inpatient ward every 4 hours over a 36-hour period
measure: Postoperative visual analogue pain scale (VAS)
time frame: 36 hours postoperative
description: assessment of each patient on his bed at inpatient ward every 4 hours over a 36-hour period
arm group label: Neostigmine group
arm group type: Active Comparator
description: At the end of the surgery patients receive 0.5mg/dose neostigmine +18ml 0.25%bupivacaine in a total volume of 20 ml.
arm group label: ketamine group
arm group type: Active Comparator
description: At the end of the surgery patients receive 0.5 mg/kg ketamine+18ml 0.25%bupivacaine in a total volume of 20 ml.
intervention type: Drug
intervention name: Neostigmine
description: patient receive 0.5mg/dose neostigmine +18ml 0.25%bupivacaine in a total volume of 20 ml.
arm group label: Neostigmine group
other name: epistigmine
intervention type: Drug
intervention name: ketamine
description: patient receive 0.5 mg/kg ketamine+18ml 0.25%bupivacaine in a total volume of 20 ml.
arm group label: ketamine group
other name: Ketalar
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Abualauon Elbiplaoy, lectural of anesthesia
role: Principal Investigator
affiliation: Assiut University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Amani Hassan Abdel-Wahab
investigator title: MD
mesh term: Pain, Postoperative
mesh term: Ketamine
mesh term: Neostigmine
sharing ipd: Undecided