<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/NCT04414995</url>
  </required_header>
  <id_info>
    <org_study_id>Pct-Ibf-FKUI</org_study_id>
    <nct_id>NCT04414995</nct_id>
  </id_info>
  <brief_title>Effect of Paracetamol and Ibuprofen Reducing Morphine Requirements After Total Knee Arthroplasty</brief_title>
  <acronym>PctIbfFKUI</acronym>
  <official_title>Effect of Paracetamol and Ibuprofen When Intravenously Given Combination or Alone in Reducing Morphine Requirements After Total Knee Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indonesia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indonesia 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>
      Adequate pain management has an important role in supporting early ambulation after the Total&#xD;
      Knee Arthroplasty (TKA). Multimodal analgesia is one of the modalities of overcoming&#xD;
      postoperative pain. The use of combination Paracetamol and Ibuprofen injection is expected to&#xD;
      reduce total morphine consumption after TKA.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The research will compare the effect of paracetamol injection and ibuprofen injection when&#xD;
      given alone or in combination to reduce morphine requirement in a patient after total knee&#xD;
      arthroplasty&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 5, 2020</start_date>
  <completion_date type="Actual">December 15, 2020</completion_date>
  <primary_completion_date type="Actual">November 30, 2020</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>Factorial Assignment</intervention_model>
    <intervention_model_description>Patients in Group 1 received a combination of 1000 mg IV paracetamol and 800 mg IV ibuprofen at the end of operation followed by 1000 mg IV paracetamol and 800 mg IV ibuprofen every 6 hours up to 72 hours.&#xD;
Patients in Group 2 received 1000 mg IV paracetamol and 100 ml IV normal salines at the end of operation followed by 1000 mg IV paracetamol and 100 ml IV normal salines every 6 hours up to 72 hours.&#xD;
Patients in Group 3 received 800 mg IV ibuprofen and 100 ml IV normal salines at the end of operation followed by 800 mg IV ibuprofen and 100 ml IV normal salines every 6 hours up to 72 hours.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>The study medication will be masked by the pharmacy. Participants, those administrating the intervention, other caregivers, outcome assessors, data managers, statisticians, and investigators drawing conclusions will be blinded to the intervention.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Total morphine requirement</measure>
    <time_frame>24 hours</time_frame>
    <description>morphine requirement in patient after total knee arthroplasty procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Numerical rating scale of pain in resting phase, walking phase, knee full flexion phase</measure>
    <time_frame>24 hours, 48 hours, 72 hours</time_frame>
    <description>amount of pain measure by numerical rating scale. Patients rate their pain from 0 to 10, Zero represents &quot;no pain,&quot; whereas 10 represents the opposite end of the pain continuum (e.g., &quot;the most intense pain imaginable,&quot; &quot;pain as intense as it could be,&quot; &quot;maximum pain&quot;)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>range of motion knee in flexion and extension</measure>
    <time_frame>24 hours, 48 hours, 72 hours</time_frame>
    <description>range of motion knee in flexion and extension</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>2MWT after total knee arthroplasty procedure</measure>
    <time_frame>24 hours, 48 hours, 72 hours</time_frame>
    <description>amount of walking length in 2 minutes</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Analgesia</condition>
  <arm_group>
    <arm_group_label>Paracetamol+Ibuprofen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in Group 1 will receive a combination of 1000 mg IV paracetamol and 800 mg IV ibuprofen at the end of operation following by 1000 mg IV paracetamol and 800 mg IV ibuprofen every 6 hours up to 72 hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Paracetamol+normal saline</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in Group 2 will receive 1000 mg IV paracetamol and 100 ml IV normal salines at the end of operation following by 1000 mg IV paracetamol and 100 ml IV normal salines every 6 hours up to 72 hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ibuprofen+normal saline</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in Group 3 will receive 800 mg IV ibuprofen and 100 ml IV normal salines at the end of operation following by 800 mg IV ibuprofen and 100 ml IV normal salines every 6 hours up to 72 hours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paracetamol injection and Ibuprofen injection</intervention_name>
    <description>Use of combination acetaminophen and ibuprofen to reduce morphine requirement inpatient after Total knee arthroplasty</description>
    <arm_group_label>Paracetamol+Ibuprofen</arm_group_label>
    <other_name>Paracetamol and Ibuprofen</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paracetamol injection and normal saline</intervention_name>
    <description>Use of paracetamol and normal saline to reduce morphine requirement inpatient after Total knee arthroplasty</description>
    <arm_group_label>Paracetamol+normal saline</arm_group_label>
    <other_name>Paracetamol injection</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ibuprofen Injection and normal saline</intervention_name>
    <description>Use of ibuprofen and normal saline to reduce morphine requirement inpatient after Total knee arthroplasty</description>
    <arm_group_label>Ibuprofen+normal saline</arm_group_label>
    <other_name>Ibuprofen injection</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patient with 20 &lt; BMI &lt; 30 kg/m2&#xD;
&#xD;
          -  Adult patient with knee varus alignment 10-20°&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Impaired cardiac, liver, and/or renal function.&#xD;
&#xD;
          -  History of substance abuse or chronic pain.&#xD;
&#xD;
          -  Patients are known to be hypersensitive to any of the components of IV ibuprofen or IV&#xD;
             paracetamol.&#xD;
&#xD;
          -  Patients currently on anticoagulation medications.&#xD;
&#xD;
          -  Inability to understand the requirements of the study or be unwilling to provide&#xD;
             written informed consent (as evidenced by signature on an informed consent document&#xD;
             approved by an Institutional Review Board) and agree to abide by the study&#xD;
             restrictions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andri MT Lubis, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fakultas Kedokteran Universitas Indonesia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Aida R Tantri, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fakultas Kedokteran Universitas Indonesia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ludwig AP Pontoh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fakultas Kedokteran Universitas Indonesia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cipto Mangunkusumo National General Hospital</name>
      <address>
        <city>Jakarta Pusat</city>
        <state>DKI Jakarta</state>
        <zip>10430</zip>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fatmawati General Hospital</name>
      <address>
        <city>Jakarta</city>
        <state>DKI Jakarta</state>
        <zip>12430</zip>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Indonesia</country>
  </location_countries>
  <reference>
    <citation>American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.</citation>
    <PMID>22227789</PMID>
  </reference>
  <reference>
    <citation>Affas F, Nygards EB, Stiller CO, Wretenberg P, Olofsson C. Pain control after total knee arthroplasty: a randomized trial comparing local infiltration anesthesia and continuous femoral block. Acta Orthop. 2011 Aug;82(4):441-7. doi: 10.3109/17453674.2011.581264. Epub 2011 May 11.</citation>
    <PMID>21561303</PMID>
  </reference>
  <reference>
    <citation>Barrington JW, Lovald ST, Ong KL, Watson HN, Emerson RH Jr. Postoperative Pain After Primary Total Knee Arthroplasty: Comparison of Local Injection Analgesic Cocktails and the Role of Demographic and Surgical Factors. J Arthroplasty. 2016 Sep;31(9 Suppl):288-92. doi: 10.1016/j.arth.2016.05.002. Epub 2016 May 12.</citation>
    <PMID>27318410</PMID>
  </reference>
  <reference>
    <citation>Oderda GM, Gan TJ, Johnson BH, Robinson SB. Effect of opioid-related adverse events on outcomes in selected surgical patients. J Pain Palliat Care Pharmacother. 2013 Mar;27(1):62-70. doi: 10.3109/15360288.2012.751956. Epub 2013 Jan 9.</citation>
    <PMID>23302094</PMID>
  </reference>
  <reference>
    <citation>Sharma V, Morgan PM, Cheng EY. Factors influencing early rehabilitation after THA: a systematic review. Clin Orthop Relat Res. 2009 Jun;467(6):1400-11. doi: 10.1007/s11999-009-0750-9. Epub 2009 Mar 10.</citation>
    <PMID>19277807</PMID>
  </reference>
  <reference>
    <citation>Woolf CJ, Salter MW. Neuronal plasticity: increasing the gain in pain. Science. 2000 Jun 9;288(5472):1765-9. doi: 10.1126/science.288.5472.1765.</citation>
    <PMID>10846153</PMID>
  </reference>
  <reference>
    <citation>Horlocker TT, Kopp SL, Pagnano MW, Hebl JR. Analgesia for total hip and knee arthroplasty: a multimodal pathway featuring peripheral nerve block. J Am Acad Orthop Surg. 2006 Mar;14(3):126-35. doi: 10.5435/00124635-200603000-00003.</citation>
    <PMID>16520363</PMID>
  </reference>
  <reference>
    <citation>Halawi MJ, Grant SA, Bolognesi MP. Multimodal Analgesia for Total Joint Arthroplasty. Orthopedics. 2015 Jul 1;38(7):e616-25. doi: 10.3928/01477447-20150701-61.</citation>
    <PMID>26186325</PMID>
  </reference>
  <reference>
    <citation>Oderda G. Challenges in the management of acute postsurgical pain. Pharmacotherapy. 2012 Sep;32(9 Suppl):6S-11S. doi: 10.1002/j.1875-9114.2012.01177.x.</citation>
    <PMID>22956493</PMID>
  </reference>
  <reference>
    <citation>Barletta JF. Clinical and economic burden of opioid use for postsurgical pain: focus on ventilatory impairment and ileus. Pharmacotherapy. 2012 Sep;32(9 Suppl):12S-8S. doi: 10.1002/j.1875-9114.2012.01178.x.</citation>
    <PMID>22956490</PMID>
  </reference>
  <reference>
    <citation>Buvanendran A. Multimodal Analgesia for Perioperative Pain Management: ASA Refresh Courses Anesthesiol. 2012;40(1):1-6.</citation>
  </reference>
  <reference>
    <citation>Rosero EB, Joshi GP. Preemptive, preventive, multimodal analgesia: what do they really mean? Plast Reconstr Surg. 2014 Oct;134(4 Suppl 2):85S-93S. doi: 10.1097/PRS.0000000000000671.</citation>
    <PMID>25255012</PMID>
  </reference>
  <reference>
    <citation>Derry CJ, Derry S, Moore RA. Single dose oral ibuprofen plus paracetamol (acetaminophen) for acute postoperative pain. Cochrane Database Syst Rev. 2013 Jun 24;2013(6):CD010210. doi: 10.1002/14651858.CD010210.pub2.</citation>
    <PMID>23794268</PMID>
  </reference>
  <reference>
    <citation>Dahl JB, Nielsen RV, Wetterslev J, Nikolajsen L, Hamunen K, Kontinen VK, Hansen MS, Kjer JJ, Mathiesen O; Scandinavian Postoperative Pain Alliance (ScaPAlli). Post-operative analgesic effects of paracetamol, NSAIDs, glucocorticoids, gabapentinoids and their combinations: a topical review. Acta Anaesthesiol Scand. 2014 Nov;58(10):1165-81. doi: 10.1111/aas.12382. Epub 2014 Aug 14.</citation>
    <PMID>25124340</PMID>
  </reference>
  <reference>
    <citation>Ong CK, Seymour RA, Lirk P, Merry AF. Combining paracetamol (acetaminophen) with nonsteroidal antiinflammatory drugs: a qualitative systematic review of analgesic efficacy for acute postoperative pain. Anesth Analg. 2010 Apr 1;110(4):1170-9. doi: 10.1213/ANE.0b013e3181cf9281. Epub 2010 Feb 8.</citation>
    <PMID>20142348</PMID>
  </reference>
  <reference>
    <citation>Thybo KH, Hagi-Pedersen D, Wetterslev J, Dahl JB, Schroder HM, Bulow HH, Bjorck JG, Mathiesen O. PANSAID - PAracetamol and NSAID in combination: study protocol for a randomised trial. Trials. 2017 Jan 10;18(1):11. doi: 10.1186/s13063-016-1749-7.</citation>
    <PMID>28069072</PMID>
  </reference>
  <results_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>
  </results_reference>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>May 31, 2020</study_first_submitted>
  <study_first_submitted_qc>May 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>December 20, 2020</last_update_submitted>
  <last_update_submitted_qc>December 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indonesia University</investigator_affiliation>
    <investigator_full_name>Andri Maruli Tua Lubis</investigator_full_name>
    <investigator_title>Head of Research Division RSCM</investigator_title>
  </responsible_party>
  <keyword>multi modal analgesia</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
    <mesh_term>Ibuprofen</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Study Protocol, Statistical Analysis Plan (SAP)</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>data will become available after study completion.</ipd_time_frame>
    <ipd_access_criteria>others researches contact</ipd_access_criteria>
  </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/NCT04414995
org study id: Pct-Ibf-FKUI
nct id: NCT04414995
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Adequate pain management has an important role in supporting early ambulation after the Total
      Knee Arthroplasty (TKA). Multimodal analgesia is one of the modalities of overcoming
      postoperative pain. The use of combination Paracetamol and Ibuprofen injection is expected to
      reduce total morphine consumption after TKA.
The research will compare the effect of paracetamol injection and ibuprofen injection when
      given alone or in combination to reduce morphine requirement in a patient after total knee
      arthroplasty
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: Patients in Group 1 received a combination of 1000 mg IV paracetamol and 800 mg IV ibuprofen at the end of operation followed by 1000 mg IV paracetamol and 800 mg IV ibuprofen every 6 hours up to 72 hours.
Patients in Group 2 received 1000 mg IV paracetamol and 100 ml IV normal salines at the end of operation followed by 1000 mg IV paracetamol and 100 ml IV normal salines every 6 hours up to 72 hours.
Patients in Group 3 received 800 mg IV ibuprofen and 100 ml IV normal salines at the end of operation followed by 800 mg IV ibuprofen and 100 ml IV normal salines every 6 hours up to 72 hours.
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: The study medication will be masked by the pharmacy. Participants, those administrating the intervention, other caregivers, outcome assessors, data managers, statisticians, and investigators drawing conclusions will be blinded to the intervention.
measure: Total morphine requirement
time frame: 24 hours
description: morphine requirement in patient after total knee arthroplasty procedure
measure: Numerical rating scale of pain in resting phase, walking phase, knee full flexion phase
time frame: 24 hours, 48 hours, 72 hours
description: amount of pain measure by numerical rating scale. Patients rate their pain from 0 to 10, Zero represents "no pain," whereas 10 represents the opposite end of the pain continuum (e.g., "the most intense pain imaginable," "pain as intense as it could be," "maximum pain")
measure: range of motion knee in flexion and extension
time frame: 24 hours, 48 hours, 72 hours
description: range of motion knee in flexion and extension
measure: 2MWT after total knee arthroplasty procedure
time frame: 24 hours, 48 hours, 72 hours
description: amount of walking length in 2 minutes
arm group label: Paracetamol+Ibuprofen
arm group type: Experimental
description: Patients in Group 1 will receive a combination of 1000 mg IV paracetamol and 800 mg IV ibuprofen at the end of operation following by 1000 mg IV paracetamol and 800 mg IV ibuprofen every 6 hours up to 72 hours.
arm group label: Paracetamol+normal saline
arm group type: Experimental
description: Patients in Group 2 will receive 1000 mg IV paracetamol and 100 ml IV normal salines at the end of operation following by 1000 mg IV paracetamol and 100 ml IV normal salines every 6 hours up to 72 hours.
arm group label: Ibuprofen+normal saline
arm group type: Experimental
description: Patients in Group 3 will receive 800 mg IV ibuprofen and 100 ml IV normal salines at the end of operation following by 800 mg IV ibuprofen and 100 ml IV normal salines every 6 hours up to 72 hours.
intervention type: Drug
intervention name: Paracetamol injection and Ibuprofen injection
description: Use of combination acetaminophen and ibuprofen to reduce morphine requirement inpatient after Total knee arthroplasty
arm group label: Paracetamol+Ibuprofen
other name: Paracetamol and Ibuprofen
intervention type: Drug
intervention name: Paracetamol injection and normal saline
description: Use of paracetamol and normal saline to reduce morphine requirement inpatient after Total knee arthroplasty
arm group label: Paracetamol+normal saline
other name: Paracetamol injection
intervention type: Drug
intervention name: Ibuprofen Injection and normal saline
description: Use of ibuprofen and normal saline to reduce morphine requirement inpatient after Total knee arthroplasty
arm group label: Ibuprofen+normal saline
other name: Ibuprofen injection
criteria: 
gender: All
minimum age: 50 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Andri MT Lubis, MD, PhD
role: Principal Investigator
affiliation: Fakultas Kedokteran Universitas Indonesia
last name: Aida R Tantri, MD
role: Principal Investigator
affiliation: Fakultas Kedokteran Universitas Indonesia
last name: Ludwig AP Pontoh, MD
role: Principal Investigator
affiliation: Fakultas Kedokteran Universitas Indonesia
facility: 
facility: 
country: Indonesia
citation: American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.
PMID: 22227789
citation: Affas F, Nygards EB, Stiller CO, Wretenberg P, Olofsson C. Pain control after total knee arthroplasty: a randomized trial comparing local infiltration anesthesia and continuous femoral block. Acta Orthop. 2011 Aug;82(4):441-7. doi: 10.3109/17453674.2011.581264. Epub 2011 May 11.
PMID: 21561303
citation: Barrington JW, Lovald ST, Ong KL, Watson HN, Emerson RH Jr. Postoperative Pain After Primary Total Knee Arthroplasty: Comparison of Local Injection Analgesic Cocktails and the Role of Demographic and Surgical Factors. J Arthroplasty. 2016 Sep;31(9 Suppl):288-92. doi: 10.1016/j.arth.2016.05.002. Epub 2016 May 12.
PMID: 27318410
citation: Oderda GM, Gan TJ, Johnson BH, Robinson SB. Effect of opioid-related adverse events on outcomes in selected surgical patients. J Pain Palliat Care Pharmacother. 2013 Mar;27(1):62-70. doi: 10.3109/15360288.2012.751956. Epub 2013 Jan 9.
PMID: 23302094
citation: Sharma V, Morgan PM, Cheng EY. Factors influencing early rehabilitation after THA: a systematic review. Clin Orthop Relat Res. 2009 Jun;467(6):1400-11. doi: 10.1007/s11999-009-0750-9. Epub 2009 Mar 10.
PMID: 19277807
citation: Woolf CJ, Salter MW. Neuronal plasticity: increasing the gain in pain. Science. 2000 Jun 9;288(5472):1765-9. doi: 10.1126/science.288.5472.1765.
PMID: 10846153
citation: Horlocker TT, Kopp SL, Pagnano MW, Hebl JR. Analgesia for total hip and knee arthroplasty: a multimodal pathway featuring peripheral nerve block. J Am Acad Orthop Surg. 2006 Mar;14(3):126-35. doi: 10.5435/00124635-200603000-00003.
PMID: 16520363
citation: Halawi MJ, Grant SA, Bolognesi MP. Multimodal Analgesia for Total Joint Arthroplasty. Orthopedics. 2015 Jul 1;38(7):e616-25. doi: 10.3928/01477447-20150701-61.
PMID: 26186325
citation: Oderda G. Challenges in the management of acute postsurgical pain. Pharmacotherapy. 2012 Sep;32(9 Suppl):6S-11S. doi: 10.1002/j.1875-9114.2012.01177.x.
PMID: 22956493
citation: Barletta JF. Clinical and economic burden of opioid use for postsurgical pain: focus on ventilatory impairment and ileus. Pharmacotherapy. 2012 Sep;32(9 Suppl):12S-8S. doi: 10.1002/j.1875-9114.2012.01178.x.
PMID: 22956490
citation: Buvanendran A. Multimodal Analgesia for Perioperative Pain Management: ASA Refresh Courses Anesthesiol. 2012;40(1):1-6.
citation: Rosero EB, Joshi GP. Preemptive, preventive, multimodal analgesia: what do they really mean? Plast Reconstr Surg. 2014 Oct;134(4 Suppl 2):85S-93S. doi: 10.1097/PRS.0000000000000671.
PMID: 25255012
citation: Derry CJ, Derry S, Moore RA. Single dose oral ibuprofen plus paracetamol (acetaminophen) for acute postoperative pain. Cochrane Database Syst Rev. 2013 Jun 24;2013(6):CD010210. doi: 10.1002/14651858.CD010210.pub2.
PMID: 23794268
citation: Dahl JB, Nielsen RV, Wetterslev J, Nikolajsen L, Hamunen K, Kontinen VK, Hansen MS, Kjer JJ, Mathiesen O; Scandinavian Postoperative Pain Alliance (ScaPAlli). Post-operative analgesic effects of paracetamol, NSAIDs, glucocorticoids, gabapentinoids and their combinations: a topical review. Acta Anaesthesiol Scand. 2014 Nov;58(10):1165-81. doi: 10.1111/aas.12382. Epub 2014 Aug 14.
PMID: 25124340
citation: Ong CK, Seymour RA, Lirk P, Merry AF. Combining paracetamol (acetaminophen) with nonsteroidal antiinflammatory drugs: a qualitative systematic review of analgesic efficacy for acute postoperative pain. Anesth Analg. 2010 Apr 1;110(4):1170-9. doi: 10.1213/ANE.0b013e3181cf9281. Epub 2010 Feb 8.
PMID: 20142348
citation: Thybo KH, Hagi-Pedersen D, Wetterslev J, Dahl JB, Schroder HM, Bulow HH, Bjorck JG, Mathiesen O. PANSAID - PAracetamol and NSAID in combination: study protocol for a randomised trial. Trials. 2017 Jan 10;18(1):11. doi: 10.1186/s13063-016-1749-7.
PMID: 28069072
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PMID: 24399578
responsible party type: Principal Investigator
investigator affiliation: Indonesia University
investigator full name: Andri Maruli Tua Lubis
investigator title: Head of Research Division RSCM
mesh term: Acetaminophen
mesh term: Ibuprofen
sharing ipd: Yes
ipd description: Study Protocol, Statistical Analysis Plan (SAP)
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: data will become available after study completion.
ipd access criteria: others researches contact