<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/NCT03249662</url>
  </required_header>
  <id_info>
    <org_study_id>si111/2017</org_study_id>
    <nct_id>NCT03249662</nct_id>
  </id_info>
  <brief_title>Efficacy of Pain Control in Different Bupivacaine Dose in Periarticular Injection in Bilateral Total Knee Arthroplasty</brief_title>
  <official_title>Efficacy of Pain Management in Different Concentrations of Bupivacaine in Periarticular Injection and Plasma Concentrations of Bupivacaine in Patients Undergoing Bilateral 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>Yes</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>
      To study efficacy of postoperative pain control of different concentrations of bupivacaine&#xD;
      for periarticular infiltration, part of multimodal analgesia, in bilateral total knee&#xD;
      arthroplasty.&#xD;
&#xD;
      To study plasma concentration of bupivacaine in patient who received spinal anesthesia and&#xD;
      single shot bilateral adductor canal block and periarticular infiltration with bupivacaine&#xD;
      for safety level.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adequate postoperative pain control reduce postoperative morbidity, multimodal analgesia&#xD;
      techniques is used for achieve this goal. multimodal analgesia for bilateral total knee&#xD;
      arthroplasty are peripheral nerve block, periarticular infiltration, NSAIDs, gabapentins and&#xD;
      others. patients undergoing bilateral total knee arthroplasty in siriraj hospital receive&#xD;
      spinal anesthesia, single shot bilateral adductor canal block and bilateral periarticular&#xD;
      infiltration with bupivacaine so patient receive a large dose of bupivacaine. the&#xD;
      investigators study the efficacy of postoperative pain of reduced dose of bupivacaine for&#xD;
      periarticular infiltration. and study plasma level of bupivacaine.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 27, 2017</start_date>
  <completion_date type="Actual">September 14, 2020</completion_date>
  <primary_completion_date type="Actual">September 14, 2020</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>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative pain score</measure>
    <time_frame>0-24 hours postoperative</time_frame>
    <description>Numerical rating scale at rest and movement in the first 24 hours postoperatively</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>plasma bupivacaine level</measure>
    <time_frame>40 minutes after 1st articular infiltration, 15,30,45,60,90 minutes after 2nd periarticular infiltratio</time_frame>
    <description>plasma bupivacaine level at 40 minutes after 1st articular infiltration, 15,30,45,60,90 minutes after 2nd periarticular infiltration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative morphine consumption</measure>
    <time_frame>first 24 hours and 24-48 hours postoperatively</time_frame>
    <description>postoperative morphine consumption at first 24 hours and 24-48 hours postoperatively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ambulation</measure>
    <time_frame>48 hours postoperatively</time_frame>
    <description>patient can walk with assistances within 48 hours postoperatively</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Bilateral Total Knee Arthroplasty</condition>
  <arm_group>
    <arm_group_label>bupivacaine 100 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>bupivacaine 100 mg ketorolac 30 mg epinephrine 400 mcg add Normal saline solution(NSS) to 80 ml divided to two syringes for bilateral periarticular infiltration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>bupivacaine 200 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>bupivacaine 200 mg ketorolac 30 mg epinephrine 400 mcg add NSS to 80 ml divided to two syringes for bilateral periarticular infiltration</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>bupivacaine 200 mg</intervention_name>
    <description>bupivacaine 200 mg ketorolac 30 mg epinephrine 400 mcg add NSS to 80 ml divided to two syringes for bilateral periarticular infiltration</description>
    <arm_group_label>bupivacaine 200 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>bupivacaine 100 mg</intervention_name>
    <description>bupivacaine 100 mg ketorolac 30 mg epinephrine 400 mcg add NSS to 80 ml divided to two syringes for bilateral periarticular infiltration</description>
    <arm_group_label>bupivacaine 100 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged more than 18 years old&#xD;
&#xD;
          -  American society of anesthesiologists physical status classification 1-3&#xD;
&#xD;
          -  Undergoing bilateral total knee arthroplasty with spinal anesthesia and single shot&#xD;
             bilateral adductor canal block&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy to bupivacaine&#xD;
&#xD;
          -  Body weight less than 50 kilograms&#xD;
&#xD;
          -  Hepatic disease&#xD;
&#xD;
          -  Coagulopathy&#xD;
&#xD;
          -  Creatinine clearance less than 60 ml/min&#xD;
&#xD;
          -  Uncontrolled cerebrovascular disease&#xD;
&#xD;
          -  Hematocrit less than 35%&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>sukanya dej-arkom, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mahidol University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Medicine Siriraj Hospital</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>Dimitris CN, Taylor BC, Mowbray JG, Steensen RN, Gaines ST. Perioperative morbidity and mortality of 2-team simultaneous bilateral total knee arthroplasty. Orthopedics. 2011 Dec 6;34(12):e841-6. doi: 10.3928/01477447-20111021-02.</citation>
    <PMID>22146199</PMID>
  </reference>
  <reference>
    <citation>Mullaji A, Kanna R, Shetty GM, Chavda V, Singh DP. Efficacy of periarticular injection of bupivacaine, fentanyl, and methylprednisolone in total knee arthroplasty:a prospective, randomized trial. J Arthroplasty. 2010 Sep;25(6):851-7. doi: 10.1016/j.arth.2009.09.007. Epub 2009 Dec 21.</citation>
    <PMID>20022457</PMID>
  </reference>
  <reference>
    <citation>Rosenberg PH, Veering BT, Urmey WF. Maximum recommended doses of local anesthetics: a multifactorial concept. Reg Anesth Pain Med. 2004 Nov-Dec;29(6):564-75; discussion 524. doi: 10.1016/j.rapm.2004.08.003.</citation>
    <PMID>15635516</PMID>
  </reference>
  <reference>
    <citation>Lapmahapaisan S, Chinachoti T, Maisat W, Kleebchan N, Chatsiricharoenkul S, Charoencholvanich K, Rungwattanakij P, Sakulpacharoen N, Sri-In J. Plasma concentrations of bupivacaine after spinal anesthesia with single shot femoral nerve block and periarticular injection in total knee arthroplasty. J Med Assoc Thai. 2014 Jul;97(7):724-9.</citation>
    <PMID>25265771</PMID>
  </reference>
  <reference>
    <citation>Andersen LO, Husted H, Otte KS, Kristensen BB, Kehlet H. High-volume infiltration analgesia in total knee arthroplasty: a randomized, double-blind, placebo-controlled trial. Acta Anaesthesiol Scand. 2008 Nov;52(10):1331-5. doi: 10.1111/j.1399-6576.2008.01777.x.</citation>
    <PMID>19025523</PMID>
  </reference>
  <reference>
    <citation>Koh IJ, Kang YG, Chang CB, Kwon SK, Seo ES, Seong SC, Kim TK. Additional pain relieving effect of intraoperative periarticular injections after simultaneous bilateral TKA: a randomized, controlled study. Knee Surg Sports Traumatol Arthrosc. 2010 Jul;18(7):916-22. doi: 10.1007/s00167-010-1051-2. Epub 2010 Jan 30.</citation>
    <PMID>20119672</PMID>
  </reference>
  <reference>
    <citation>Wulf H, Gleim M, Schele HA. Plasma concentrations of bupivacaine after lumbar sympathetic block. Anesth Analg. 1994 Nov;79(5):918-20. doi: 10.1213/00000539-199411000-00017. Erratum In: Anesth Analg 1995 Jul;81(1):213.</citation>
    <PMID>7978410</PMID>
  </reference>
  <reference>
    <citation>Lapmahapaisan S, Chinachoti T, Kongpatanakul S, Chatsiricharoenkul S, Tovnich B, Duangkaew W, Pongnarin P, Sakulpacharoen N, Somcharoen W. Plasma concentrations of bupivacaine after spinal anesthesia with single shot femoral nerve block in total knee arthroplasty. J Med Assoc Thai. 2013 Mar;96(3):312-7.</citation>
    <PMID>23539934</PMID>
  </reference>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>September 14, 2020</last_update_submitted>
  <last_update_submitted_qc>September 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>periarticular infiltration</keyword>
  <keyword>postoperative pain management</keyword>
  <keyword>plasma level of bupivacaine</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</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/NCT03249662
org study id: si111/2017
nct id: NCT03249662
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To study efficacy of postoperative pain control of different concentrations of bupivacaine
      for periarticular infiltration, part of multimodal analgesia, in bilateral total knee
      arthroplasty.

      To study plasma concentration of bupivacaine in patient who received spinal anesthesia and
      single shot bilateral adductor canal block and periarticular infiltration with bupivacaine
      for safety level.
Adequate postoperative pain control reduce postoperative morbidity, multimodal analgesia
      techniques is used for achieve this goal. multimodal analgesia for bilateral total knee
      arthroplasty are peripheral nerve block, periarticular infiltration, NSAIDs, gabapentins and
      others. patients undergoing bilateral total knee arthroplasty in siriraj hospital receive
      spinal anesthesia, single shot bilateral adductor canal block and bilateral periarticular
      infiltration with bupivacaine so patient receive a large dose of bupivacaine. the
      investigators study the efficacy of postoperative pain of reduced dose of bupivacaine for
      periarticular infiltration. and study plasma level of bupivacaine.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: postoperative pain score
time frame: 0-24 hours postoperative
description: Numerical rating scale at rest and movement in the first 24 hours postoperatively
measure: plasma bupivacaine level
time frame: 40 minutes after 1st articular infiltration, 15,30,45,60,90 minutes after 2nd periarticular infiltratio
description: plasma bupivacaine level at 40 minutes after 1st articular infiltration, 15,30,45,60,90 minutes after 2nd periarticular infiltration
measure: postoperative morphine consumption
time frame: first 24 hours and 24-48 hours postoperatively
description: postoperative morphine consumption at first 24 hours and 24-48 hours postoperatively
measure: ambulation
time frame: 48 hours postoperatively
description: patient can walk with assistances within 48 hours postoperatively
arm group label: bupivacaine 100 mg
arm group type: Experimental
description: bupivacaine 100 mg ketorolac 30 mg epinephrine 400 mcg add Normal saline solution(NSS) to 80 ml divided to two syringes for bilateral periarticular infiltration
arm group label: bupivacaine 200 mg
arm group type: Active Comparator
description: bupivacaine 200 mg ketorolac 30 mg epinephrine 400 mcg add NSS to 80 ml divided to two syringes for bilateral periarticular infiltration
intervention type: Procedure
intervention name: bupivacaine 200 mg
description: bupivacaine 200 mg ketorolac 30 mg epinephrine 400 mcg add NSS to 80 ml divided to two syringes for bilateral periarticular infiltration
arm group label: bupivacaine 200 mg
intervention type: Drug
intervention name: bupivacaine 100 mg
description: bupivacaine 100 mg ketorolac 30 mg epinephrine 400 mcg add NSS to 80 ml divided to two syringes for bilateral periarticular infiltration
arm group label: bupivacaine 100 mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: sukanya dej-arkom, MD
role: Principal Investigator
affiliation: Mahidol University
facility: 
country: Thailand
citation: Dimitris CN, Taylor BC, Mowbray JG, Steensen RN, Gaines ST. Perioperative morbidity and mortality of 2-team simultaneous bilateral total knee arthroplasty. Orthopedics. 2011 Dec 6;34(12):e841-6. doi: 10.3928/01477447-20111021-02.
PMID: 22146199
citation: Mullaji A, Kanna R, Shetty GM, Chavda V, Singh DP. Efficacy of periarticular injection of bupivacaine, fentanyl, and methylprednisolone in total knee arthroplasty:a prospective, randomized trial. J Arthroplasty. 2010 Sep;25(6):851-7. doi: 10.1016/j.arth.2009.09.007. Epub 2009 Dec 21.
PMID: 20022457
citation: Rosenberg PH, Veering BT, Urmey WF. Maximum recommended doses of local anesthetics: a multifactorial concept. Reg Anesth Pain Med. 2004 Nov-Dec;29(6):564-75; discussion 524. doi: 10.1016/j.rapm.2004.08.003.
PMID: 15635516
citation: Lapmahapaisan S, Chinachoti T, Maisat W, Kleebchan N, Chatsiricharoenkul S, Charoencholvanich K, Rungwattanakij P, Sakulpacharoen N, Sri-In J. Plasma concentrations of bupivacaine after spinal anesthesia with single shot femoral nerve block and periarticular injection in total knee arthroplasty. J Med Assoc Thai. 2014 Jul;97(7):724-9.
PMID: 25265771
citation: Andersen LO, Husted H, Otte KS, Kristensen BB, Kehlet H. High-volume infiltration analgesia in total knee arthroplasty: a randomized, double-blind, placebo-controlled trial. Acta Anaesthesiol Scand. 2008 Nov;52(10):1331-5. doi: 10.1111/j.1399-6576.2008.01777.x.
PMID: 19025523
citation: Koh IJ, Kang YG, Chang CB, Kwon SK, Seo ES, Seong SC, Kim TK. Additional pain relieving effect of intraoperative periarticular injections after simultaneous bilateral TKA: a randomized, controlled study. Knee Surg Sports Traumatol Arthrosc. 2010 Jul;18(7):916-22. doi: 10.1007/s00167-010-1051-2. Epub 2010 Jan 30.
PMID: 20119672
citation: Wulf H, Gleim M, Schele HA. Plasma concentrations of bupivacaine after lumbar sympathetic block. Anesth Analg. 1994 Nov;79(5):918-20. doi: 10.1213/00000539-199411000-00017. Erratum In: Anesth Analg 1995 Jul;81(1):213.
PMID: 7978410
citation: Lapmahapaisan S, Chinachoti T, Kongpatanakul S, Chatsiricharoenkul S, Tovnich B, Duangkaew W, Pongnarin P, Sakulpacharoen N, Somcharoen W. Plasma concentrations of bupivacaine after spinal anesthesia with single shot femoral nerve block in total knee arthroplasty. J Med Assoc Thai. 2013 Mar;96(3):312-7.
PMID: 23539934
responsible party type: Sponsor
mesh term: Bupivacaine
sharing ipd: Undecided