<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/NCT03758560</url>
  </required_header>
  <id_info>
    <org_study_id>IRC/1441/018</org_study_id>
    <nct_id>NCT03758560</nct_id>
  </id_info>
  <brief_title>Preoperative Pain Catastrophizing and Its Association With Postoperative Pain After Lower Limb Trauma Surgery</brief_title>
  <official_title>Association of Preoperative Pain Catastrophizing With Postoperative Pain After Lower Limb Trauma Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>B.P. Koirala Institute of Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>B.P. Koirala Institute of Health Sciences</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>
      The Pain Catastrophizing Scale (PCS) is a psychometric tool to identify PC. A positive&#xD;
      correlation between PCS scores and various pain outcomes has been reported in acute and&#xD;
      chronic pain settings. Preoperative catastrophizing is associated with an increased intensity&#xD;
      of postoperative pain and more analgesic consumption. Likewise, a recent meta-analysis&#xD;
      revealed that PC is a strong predictor of persistent postsurgical pain. The Nepali version of&#xD;
      PCS has been validated recently in patients with chronic pain. However, it has not been used&#xD;
      in patients with acute pain. Therefore, our aim is to assess the relationship between&#xD;
      preoperative Nepali PCS (N-PCS) scores and postoperative pain intensity and total opioid&#xD;
      consumption in patients with musculoskeletal trauma planned for surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After approval from Institute Review Committee, we will assess eligibility of patients&#xD;
      admitted in-patient-unit of orthopaedic ward planned for lower limb trauma surgery under&#xD;
      spinal anesthesia. Recruited patients will be counseled and informed about the study and&#xD;
      information sheet and consent form provided. Will obtain consent from the participant.&#xD;
      patients will be asked to complete N- PCS questionnaire preoperatively a night before surgery&#xD;
      in patient unit. On arrival to the operating room, standard monitoring will be applied. All&#xD;
      the patients will receive spinal anaesthesia with 2.6 ml of hyperbaric bupivacaine (0.5%) and&#xD;
      fentanyl 20 µg. NRS scale will be used to assess the intensity of their pain postoperatively&#xD;
      on arrival to Post-anesthesia care unit, at 2, 4, 6, 12 h and 24 h after the end of surgery.&#xD;
      One gram paracetamol IV and Ketorolac 30 mg IV will be given at the end of surgery and&#xD;
      continued at 6 and 8 h intervals postoperatively. If the Numeric rating scale (NRS) for pain&#xD;
      is &gt; 3 at rest, tramadol 50 mg IV bolus administered, and repeated at 10 min intervals until&#xD;
      NRS was ≤ 3 for the first 24 h. Patients will be asked to rate their worst or maximum pain&#xD;
      intensity during the first 24 hours after surgery, on an 11-point numerical rating scale.&#xD;
      Socio-demographic variables (age, BMI, ethnicity, gender, socio-economic status, occupation&#xD;
      and education), preoperative anxiety of the participant will be recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 16, 2018</start_date>
  <completion_date type="Actual">September 3, 2019</completion_date>
  <primary_completion_date type="Actual">August 16, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation of preoperative pain catastrophizing scale (PCS) scores with maximum pain severity at 24 hrs post-operatively.</measure>
    <time_frame>24 hours postoperatively</time_frame>
    <description>Correlation of preoperative pain catastrophizing scale scores with maximum pain severity at 24 hrs post-operatively. PCS consists of 13 items rated on a 5-point Likert scales from 0 (never) to 4 (all the time) points. The total score for the PCS is 52, with points more than 24 indicating a high level of catastrophizing. Worst or maximum pain intensity during the first 24 hours after surgery is assessed on an 11-point numerical rating scale (NRS). Pain is rated on a 0 to 11 NRS, with 0=&quot;no pain&quot; or and 10=pain &quot;as bad as you can imagine.&quot;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between preoperative pain catastrophizing scale (PCS) scores with total tramadol consumption postoperatively at 24 hrs</measure>
    <time_frame>24 hrs postoperatively</time_frame>
    <description>Correlation between preoperative pain catastrophizing scale scores with total tramadol consumption postoperatively upto 24 hrs. PCS consists of 13 items rated on a 5-point Likert scales from 0 (never) to 4 (all the time) points. The total score for the PCS is 52, with points more than 24 indicating a high level of catastrophizing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of preoperative pain catastrophizing scale (PCS) scores with risk factors for severe pain postoperatively</measure>
    <time_frame>24 hrs postoperatively</time_frame>
    <description>risk factors include: Age, gender, BMI, socio-economic condition, preoperative anxiety</description>
  </secondary_outcome>
  <enrollment type="Actual">135</enrollment>
  <condition>Pain, Postoperative</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pre-operative Nepali version of pain catastrophizing scale (PCS) questionnaire</intervention_name>
    <description>Patients will be asked to complete the scores based Nepali version of pain catastrophizing scale (PCS) questionnaire preoperatively</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with lower limb musculo-skeletal trauma admitted in the orthopaedic unit of&#xD;
        BPKIHS and planned for elective surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients with traumatic lower-limb injury scheduled for lower-extremity surgery under&#xD;
        spinal anaesthesia.&#xD;
&#xD;
        American Society of Anaesthesiologists physical status I or II, Age between 18 and 65 years&#xD;
        of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non- responders, Those unable to read and write; or Patients with known psychiatric&#xD;
             disorder, Prior intake of pain medication, and Chronic pain.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>BP Koirala Institute of Health Sciences (BPKIHS)</name>
      <address>
        <city>Dharān Bāzār</city>
        <state>Koshi</state>
        <zip>56700</zip>
        <country>Nepal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Nepal</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>November 25, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>September 6, 2019</last_update_submitted>
  <last_update_submitted_qc>September 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>B.P. Koirala Institute of Health Sciences</investigator_affiliation>
    <investigator_full_name>Dr Asish Subedi</investigator_full_name>
    <investigator_title>Principal Investigator</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>
  <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/NCT03758560
org study id: IRC/1441/018
nct id: NCT03758560
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Pain Catastrophizing Scale (PCS) is a psychometric tool to identify PC. A positive
      correlation between PCS scores and various pain outcomes has been reported in acute and
      chronic pain settings. Preoperative catastrophizing is associated with an increased intensity
      of postoperative pain and more analgesic consumption. Likewise, a recent meta-analysis
      revealed that PC is a strong predictor of persistent postsurgical pain. The Nepali version of
      PCS has been validated recently in patients with chronic pain. However, it has not been used
      in patients with acute pain. Therefore, our aim is to assess the relationship between
      preoperative Nepali PCS (N-PCS) scores and postoperative pain intensity and total opioid
      consumption in patients with musculoskeletal trauma planned for surgery.
After approval from Institute Review Committee, we will assess eligibility of patients
      admitted in-patient-unit of orthopaedic ward planned for lower limb trauma surgery under
      spinal anesthesia. Recruited patients will be counseled and informed about the study and
      information sheet and consent form provided. Will obtain consent from the participant.
      patients will be asked to complete N- PCS questionnaire preoperatively a night before surgery
      in patient unit. On arrival to the operating room, standard monitoring will be applied. All
      the patients will receive spinal anaesthesia with 2.6 ml of hyperbaric bupivacaine (0.5%) and
      fentanyl 20 µg. NRS scale will be used to assess the intensity of their pain postoperatively
      on arrival to Post-anesthesia care unit, at 2, 4, 6, 12 h and 24 h after the end of surgery.
      One gram paracetamol IV and Ketorolac 30 mg IV will be given at the end of surgery and
      continued at 6 and 8 h intervals postoperatively. If the Numeric rating scale (NRS) for pain
      is > 3 at rest, tramadol 50 mg IV bolus administered, and repeated at 10 min intervals until
      NRS was ≤ 3 for the first 24 h. Patients will be asked to rate their worst or maximum pain
      intensity during the first 24 hours after surgery, on an 11-point numerical rating scale.
      Socio-demographic variables (age, BMI, ethnicity, gender, socio-economic status, occupation
      and education), preoperative anxiety of the participant will be recorded.
observational model: Cohort
time perspective: Prospective
measure: Correlation of preoperative pain catastrophizing scale (PCS) scores with maximum pain severity at 24 hrs post-operatively.
time frame: 24 hours postoperatively
description: Correlation of preoperative pain catastrophizing scale scores with maximum pain severity at 24 hrs post-operatively. PCS consists of 13 items rated on a 5-point Likert scales from 0 (never) to 4 (all the time) points. The total score for the PCS is 52, with points more than 24 indicating a high level of catastrophizing. Worst or maximum pain intensity during the first 24 hours after surgery is assessed on an 11-point numerical rating scale (NRS). Pain is rated on a 0 to 11 NRS, with 0="no pain" or and 10=pain "as bad as you can imagine."
measure: Correlation between preoperative pain catastrophizing scale (PCS) scores with total tramadol consumption postoperatively at 24 hrs
time frame: 24 hrs postoperatively
description: Correlation between preoperative pain catastrophizing scale scores with total tramadol consumption postoperatively upto 24 hrs. PCS consists of 13 items rated on a 5-point Likert scales from 0 (never) to 4 (all the time) points. The total score for the PCS is 52, with points more than 24 indicating a high level of catastrophizing.
measure: Correlation of preoperative pain catastrophizing scale (PCS) scores with risk factors for severe pain postoperatively
time frame: 24 hrs postoperatively
description: risk factors include: Age, gender, BMI, socio-economic condition, preoperative anxiety
intervention type: Other
intervention name: Pre-operative Nepali version of pain catastrophizing scale (PCS) questionnaire
description: Patients will be asked to complete the scores based Nepali version of pain catastrophizing scale (PCS) questionnaire preoperatively
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Nepal
responsible party type: Principal Investigator
investigator affiliation: B.P. Koirala Institute of Health Sciences
investigator full name: Dr Asish Subedi
investigator title: Principal Investigator
mesh term: Pain, Postoperative
sharing ipd: Undecided