<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/NCT03232957</url>
  </required_header>
  <id_info>
    <org_study_id>Si 331/2017</org_study_id>
    <nct_id>NCT03232957</nct_id>
  </id_info>
  <brief_title>Intrathecal Morphine for Unilateral Total Knee Arthroplasty</brief_title>
  <official_title>Efficacy and Side Effects of Intrathecal Morphine in Multimodal Analgesia for Unilateral Total Knee Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mahidol University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mahidol 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 evaluates postoperative numerical pain score and systemic opioid requirement&#xD;
      within 48 hours for unilateral total knee arthroplasty. Comparing among 3 groups of&#xD;
      intrathecal morphine; 0,50, 100 ug with multimodal analgesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intrathecal opioid is effective postoperative analgesia for orthopedic lower extremity&#xD;
      surgery. However there are some limitations such as nausea, vomiting, pruritus, dizziness.&#xD;
      Nowadays multimodal analgesia is used in unilateral total knee arthroplasty include oral&#xD;
      analgesic drugs, adductor canal block and local analgesia infiltration.&#xD;
&#xD;
      This study evaluates whether intrathecal opioid should be added in the role of multimodal&#xD;
      analgesia in total knee arthroplasty.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">July 31, 2019</completion_date>
  <primary_completion_date type="Actual">February 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>
    <masking_description>In the anesthetic record, 0.5% isobaric bupivacaine with study drug is recorded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Numerical rating scale</measure>
    <time_frame>Within 48 hours</time_frame>
    <description>Numerical rating scale 0-10</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Morphine requirement</measure>
    <time_frame>Within 48 hours</time_frame>
    <description>Systemic morphine requirement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nausea vomiting</measure>
    <time_frame>Within 48 hours</time_frame>
    <description>Incidence and severity of nausea and vomiting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pruritus</measure>
    <time_frame>Within 48 hours</time_frame>
    <description>Incidence and severity of pruritus</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">131</enrollment>
  <condition>Primary Osteoarthritis of Knee Nos</condition>
  <arm_group>
    <arm_group_label>No IT morphine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Spinal block with 0.5% isobaric with no intrathecal morphine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>50 ug IT morphine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Spinal block with 0.5% isobaric with 50 ug intrathecal morphine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>100 ug IT morphine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Spinal block with 0.5% isobaric with 100 ug intrathecal morphine</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>50 ug IT morphine</intervention_name>
    <description>Spinal block with bupivacaine and intrathecal morphine 50 ug</description>
    <arm_group_label>50 ug IT morphine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>100 ug IT morphine</intervention_name>
    <description>Spinal block with bupivacaine and intrathecal morphine 100 ug</description>
    <arm_group_label>100 ug IT morphine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>No IT morphine</intervention_name>
    <description>Spinal block with bupivacaine and intrathecal morphine 0 ug</description>
    <arm_group_label>No IT morphine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Morphine</intervention_name>
    <description>intrathecal morphine</description>
    <arm_group_label>100 ug IT morphine</arm_group_label>
    <arm_group_label>50 ug IT morphine</arm_group_label>
    <arm_group_label>No IT morphine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>0.5 isobaric bupivacaine</description>
    <arm_group_label>100 ug IT morphine</arm_group_label>
    <arm_group_label>50 ug IT morphine</arm_group_label>
    <arm_group_label>No IT morphine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged more than 18 years old undergoing unilateral total knee arthroplasty&#xD;
&#xD;
          -  American Society of Anesthesiologists physical status classification 1-3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants deny to enroll the study&#xD;
&#xD;
          -  Allergy to local anesthetics, opioid and NSAIDs&#xD;
&#xD;
          -  Hepatic disease&#xD;
&#xD;
          -  Contraindication for neuraxial block or adductor canal block&#xD;
&#xD;
          -  Uncontrolled cardiovascular disease&#xD;
&#xD;
          -  Creatinine clearance less than 50 ml/min&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Suwimon Tangwiwat, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculty of Medicine Siriraj Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Medicine Siriraj Hospital, Mahidol University</name>
      <address>
        <city>Bangkok Noi</city>
        <state>Bangkok</state>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <reference>
    <citation>Stowers MD, Lemanu DP, Coleman B, Hill AG, Munro JT. Review article: Perioperative care in enhanced recovery for total hip and knee arthroplasty. J Orthop Surg (Hong Kong). 2014 Dec;22(3):383-92. doi: 10.1177/230949901402200324.</citation>
    <PMID>25550024</PMID>
  </reference>
  <reference>
    <citation>Rathmell JP, Pino CA, Taylor R, Patrin T, Viani BA. Intrathecal morphine for postoperative analgesia: a randomized, controlled, dose-ranging study after hip and knee arthroplasty. Anesth Analg. 2003 Nov;97(5):1452-1457. doi: 10.1213/01.ANE.0000083374.44039.9E.</citation>
    <PMID>14570664</PMID>
  </reference>
  <reference>
    <citation>Ibrahim MS, Alazzawi S, Nizam I, Haddad FS. An evidence-based review of enhanced recovery interventions in knee replacement surgery. Ann R Coll Surg Engl. 2013 Sep;95(6):386-9. doi: 10.1308/003588413X13629960046435.</citation>
    <PMID>24025284</PMID>
  </reference>
  <reference>
    <citation>Hassett P, Ansari B, Gnanamoorthy P, Kinirons B, Laffey JG. Determination Of The Efficacy And Side-effect Profile Of Lower Doses Of Intrathecal Morphine In Patients Undergoing Total Knee Arthroplasty. BMC Anesthesiol. 2008 Sep 24;8:5. doi: 10.1186/1471-2253-8-5.</citation>
    <PMID>18816386</PMID>
  </reference>
  <reference>
    <citation>Nakai T, Tamaki M, Nakamura T, Nakai T, Onishi A, Hashimoto K. Controlling pain after total knee arthroplasty using a multimodal protocol with local periarticular injections. J Orthop. 2013 Mar 17;10(2):92-4. doi: 10.1016/j.jor.2013.02.001. eCollection 2013.</citation>
    <PMID>24403757</PMID>
  </reference>
  <reference>
    <citation>McCartney CJ, Nelligan K. Postoperative pain management after total knee arthroplasty in elderly patients: treatment options. Drugs Aging. 2014 Feb;31(2):83-91. doi: 10.1007/s40266-013-0148-y.</citation>
    <PMID>24399578</PMID>
  </reference>
  <reference>
    <citation>Kunopart M, Chanthong P, Thongpolswat N, Intiyanaravut T, Pethuahong C. Effects of single shot femoral nerve block combined with intrathecal morphine for postoperative analgesia: a randomized, controlled, dose-ranging study after total knee arthroplasty. J Med Assoc Thai. 2014 Feb;97(2):195-202.</citation>
    <PMID>24765899</PMID>
  </reference>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>May 21, 2021</last_update_submitted>
  <last_update_submitted_qc>May 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mahidol University</investigator_affiliation>
    <investigator_full_name>Suwimon Tangwiwat</investigator_full_name>
    <investigator_title>Assistant professor, Department of Anesthesiology</investigator_title>
  </responsible_party>
  <keyword>Intrathecal morphine, total knee arthroplasty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Morphine</mesh_term>
    <mesh_term>Bupivacaine</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/NCT03232957
org study id: Si 331/2017
nct id: NCT03232957
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates postoperative numerical pain score and systemic opioid requirement
      within 48 hours for unilateral total knee arthroplasty. Comparing among 3 groups of
      intrathecal morphine; 0,50, 100 ug with multimodal analgesia.
Intrathecal opioid is effective postoperative analgesia for orthopedic lower extremity
      surgery. However there are some limitations such as nausea, vomiting, pruritus, dizziness.
      Nowadays multimodal analgesia is used in unilateral total knee arthroplasty include oral
      analgesic drugs, adductor canal block and local analgesia infiltration.

      This study evaluates whether intrathecal opioid should be added in the role of multimodal
      analgesia in total knee arthroplasty.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: In the anesthetic record, 0.5% isobaric bupivacaine with study drug is recorded.
measure: Numerical rating scale
time frame: Within 48 hours
description: Numerical rating scale 0-10
measure: Morphine requirement
time frame: Within 48 hours
description: Systemic morphine requirement
measure: Nausea vomiting
time frame: Within 48 hours
description: Incidence and severity of nausea and vomiting
measure: Pruritus
time frame: Within 48 hours
description: Incidence and severity of pruritus
arm group label: No IT morphine
arm group type: Experimental
description: Spinal block with 0.5% isobaric with no intrathecal morphine
arm group label: 50 ug IT morphine
arm group type: Experimental
description: Spinal block with 0.5% isobaric with 50 ug intrathecal morphine
arm group label: 100 ug IT morphine
arm group type: Experimental
description: Spinal block with 0.5% isobaric with 100 ug intrathecal morphine
intervention type: Procedure
intervention name: 50 ug IT morphine
description: Spinal block with bupivacaine and intrathecal morphine 50 ug
arm group label: 50 ug IT morphine
intervention type: Procedure
intervention name: 100 ug IT morphine
description: Spinal block with bupivacaine and intrathecal morphine 100 ug
arm group label: 100 ug IT morphine
intervention type: Procedure
intervention name: No IT morphine
description: Spinal block with bupivacaine and intrathecal morphine 0 ug
arm group label: No IT morphine
intervention type: Drug
intervention name: Morphine
description: intrathecal morphine
arm group label: 100 ug IT morphine
arm group label: 50 ug IT morphine
arm group label: No IT morphine
intervention type: Drug
intervention name: Bupivacaine
description: 0.5 isobaric bupivacaine
arm group label: 100 ug IT morphine
arm group label: 50 ug IT morphine
arm group label: No IT morphine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Suwimon Tangwiwat, MD
role: Principal Investigator
affiliation: Faculty of Medicine Siriraj Hospital
facility: 
country: Thailand
citation: Stowers MD, Lemanu DP, Coleman B, Hill AG, Munro JT. Review article: Perioperative care in enhanced recovery for total hip and knee arthroplasty. J Orthop Surg (Hong Kong). 2014 Dec;22(3):383-92. doi: 10.1177/230949901402200324.
PMID: 25550024
citation: Rathmell JP, Pino CA, Taylor R, Patrin T, Viani BA. Intrathecal morphine for postoperative analgesia: a randomized, controlled, dose-ranging study after hip and knee arthroplasty. Anesth Analg. 2003 Nov;97(5):1452-1457. doi: 10.1213/01.ANE.0000083374.44039.9E.
PMID: 14570664
citation: Ibrahim MS, Alazzawi S, Nizam I, Haddad FS. An evidence-based review of enhanced recovery interventions in knee replacement surgery. Ann R Coll Surg Engl. 2013 Sep;95(6):386-9. doi: 10.1308/003588413X13629960046435.
PMID: 24025284
citation: Hassett P, Ansari B, Gnanamoorthy P, Kinirons B, Laffey JG. Determination Of The Efficacy And Side-effect Profile Of Lower Doses Of Intrathecal Morphine In Patients Undergoing Total Knee Arthroplasty. BMC Anesthesiol. 2008 Sep 24;8:5. doi: 10.1186/1471-2253-8-5.
PMID: 18816386
citation: Nakai T, Tamaki M, Nakamura T, Nakai T, Onishi A, Hashimoto K. Controlling pain after total knee arthroplasty using a multimodal protocol with local periarticular injections. J Orthop. 2013 Mar 17;10(2):92-4. doi: 10.1016/j.jor.2013.02.001. eCollection 2013.
PMID: 24403757
citation: McCartney CJ, Nelligan K. Postoperative pain management after total knee arthroplasty in elderly patients: treatment options. Drugs Aging. 2014 Feb;31(2):83-91. doi: 10.1007/s40266-013-0148-y.
PMID: 24399578
citation: Kunopart M, Chanthong P, Thongpolswat N, Intiyanaravut T, Pethuahong C. Effects of single shot femoral nerve block combined with intrathecal morphine for postoperative analgesia: a randomized, controlled, dose-ranging study after total knee arthroplasty. J Med Assoc Thai. 2014 Feb;97(2):195-202.
PMID: 24765899
responsible party type: Principal Investigator
investigator affiliation: Mahidol University
investigator full name: Suwimon Tangwiwat
investigator title: Assistant professor, Department of Anesthesiology
mesh term: Osteoarthritis, Knee
mesh term: Morphine
mesh term: Bupivacaine
sharing ipd: No