<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/NCT03249766</url>
  </required_header>
  <id_info>
    <org_study_id>1900</org_study_id>
    <nct_id>NCT03249766</nct_id>
  </id_info>
  <brief_title>Study of Prevalence of Ipsilateral Shoulder Pain in Patients After Thoracic Surgeries</brief_title>
  <official_title>Prospective Observational Study of Prevalence of Ipsilateral Shoulder Pain in Patients After Thoracic Surgeries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tata Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tata Memorial Hospital</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>
      Thoracic surgeries are associated with significant operative trauma1. While thoracic epidural&#xD;
      analgesia may help control the incisional component of the pain, an excruciating&#xD;
      postthoracotomy. Ipsilateral Shoulder Pain (ISP) could under mine pain management in the post&#xD;
      thoracotomy patient2. The incidence of ISP ranges from 21% to 97%3. ISP impairs respiration,&#xD;
      mobility, and physical therapy in the early postoperative period4. The etiology of ISP is&#xD;
      unclear. Several hypotheses have been proposed as possible causes of ISP, including&#xD;
      transection of a major bronchus, ligament distraction by surgical retraction, shoulder joint&#xD;
      strain as a result of intraoperative positioning, pleural irritation due to the thoracostomy&#xD;
      tube, and referred pain from irritation of the pericardium or mediastinal and diaphragmatic&#xD;
      surfaces2, 5, 6. ISP is defined as the pain occurring on the operated side of thoracic&#xD;
      surgeries in the immediate postoperative period as early as one hour after surgery6,of dull&#xD;
      aching, stabbing, burning, electric or throbbing nature of moderate to severe intensity and&#xD;
      resistant to treatment, most commonly located in the region of the deltoid muscle or on the&#xD;
      posterior or superior surface of the arm or above ⅓ of the lateral part of the clavicle on&#xD;
      the anterior surface of the chest, lasting 3-4 days2, 7-11.The primary objective of this&#xD;
      study is to find out the prevalence of ISP and the risk factors associated with it.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a prospective observational study, which will be done over a period of one year&#xD;
      (Upto 250 patients) after approval from ethics committee. The data of the first three months&#xD;
      will be analysed (Upto 60 patients) and will presented as a thesis for MD (Anaesthesia). It&#xD;
      will be carried out at Tata Memorial Centre, Mumbai. After Institutional Ethics Committee&#xD;
      approval, Written informed consent in the language the patient understands the best will be&#xD;
      obtained undergoing thoracic surgeries where the pleura is opened including Thoracotomy,&#xD;
      Video Assisted Thoracic Surgeries (VATS). Data over a three months period will be collected.&#xD;
      Pain at the incisional site and Ipsilateral shoulder pain (ISP) will be assessed separately&#xD;
      using the numeric rating scale (NRS) during the patients' stay in the postanesthesia care&#xD;
      unit (PACU) by an independent assessor, at 1 hour, 6 hours and 12 hours after coming to the&#xD;
      PACU. The characteristics, intensity and pain at shoulder at rest and movement will also be&#xD;
      assessed. Data including age, sex, BMI, American Society of Anesthesiologists (ASA) physical&#xD;
      status, diagnosis, side and type of operation, surgical approach, positioning during surgery,&#xD;
      duration of surgery, type of regional anesthesia, and, in patients with epidural anesthesia,&#xD;
      level of catheter placement will also be recorded.&#xD;
&#xD;
      All male &amp; female patients (aged 18-75 years) who undergo thoracic surgeries where the pleura&#xD;
      is opened including Video Assisted Thoracic Surgeries (VATS)&#xD;
&#xD;
      EXCLUSION CRITERIA:&#xD;
&#xD;
        1. presence of preoperative shoulder pain,&#xD;
&#xD;
        2. preoperative shoulder pathology,&#xD;
&#xD;
        3. use of analgesics for more than 1 week preoperatively,&#xD;
&#xD;
        4. inability to understand the numeric rating scale(NRS)scoring system for pain assessment&#xD;
&#xD;
        5. failure to extubate at the end of surgery.&#xD;
&#xD;
        6. Patients who haven't given consent&#xD;
&#xD;
        7. Age &lt; 18yrs and &gt; 75 yrs.&#xD;
&#xD;
      STATISTICAL ANALYSIS:&#xD;
&#xD;
      Since the study will be done over a period of twelve months, there is no sample size.&#xD;
&#xD;
      Continuous variables will be analyzed using independent t-test or Mann Whitney U test as per&#xD;
      the distribution of the data for continuous variables. Categorical variables will be analyzed&#xD;
      using Chi-square test or Fisher's exact test. P-value &lt; 0.05 will be considered statistical&#xD;
      significant. Risk factors of ISP will be analyzed using univariate and multivariate binary&#xD;
      regression with robust estimates to calculate odds ratio (OR) and their 95% confidence&#xD;
      interval. A manual stepwise forward logistic regression will be used to extract univariate&#xD;
      independent variables. A p value ≤ 0.2 by univariate analysis will be used as the criterion&#xD;
      for choosing variables to be included in the model for multivariate analysis. A p value &lt;0.05&#xD;
      is considered statistically significant. Cut-off points of the independent variables,&#xD;
      including age group and duration of surgery, are estimated by the method of maximum&#xD;
      likelihood to achieve best discrimination between patients with and without ISP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 22, 2017</start_date>
  <completion_date type="Actual">August 21, 2018</completion_date>
  <primary_completion_date type="Actual">August 21, 2018</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>Prevalence of Ipsilateral shoulder pain</measure>
    <time_frame>Upto 12 hours post surgery</time_frame>
    <description>Numeric rating scale within 12 hours post operative</description>
  </primary_outcome>
  <enrollment type="Actual">370</enrollment>
  <condition>Lung Cancer</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observational</intervention_name>
    <description>Observational study</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This will be a prospective observational study, which will be done over a period of one&#xD;
        year (Upto 250 patients) after approval from ethics committee. The data of the first three&#xD;
        months will be analysed (Upto 60 patients) and will presented as a thesis for MD&#xD;
        (Anaesthesia). It will be carried out at Tata Memorial Centre, Mumbai. Data over a three&#xD;
        months period will be collected. Pain at the incisional site and Ipsilateral shoulder pain&#xD;
        (ISP) will be assessed separately using the numeric rating scale (NRS) during the patients'&#xD;
        stay in the postanesthesia care unit (PACU) by an independent assessor, at 1 hour, 6 hours&#xD;
        and 12 hours after coming to the PACU. The characteristics, intensity and pain at shoulder&#xD;
        at rest and movement will also be assessed.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All male &amp; female patients (aged 18-75 years) who undergo thoracic surgeries where the&#xD;
             pleura is opened including Video Assisted Thoracic Surgeries (VATS)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  presence of preoperative shoulder pain,&#xD;
&#xD;
          -  preoperative shoulder pathology,&#xD;
&#xD;
          -  use of analgesics for more than 1 week preoperatively,&#xD;
&#xD;
          -  inability to understand the numeric rating scale(NRS)scoring system for pain&#xD;
             assessment&#xD;
&#xD;
          -  failure to extubate at the end of surgery.&#xD;
&#xD;
          -  Patients who haven't given consent&#xD;
&#xD;
          -  Age &lt; 18yrs and &gt; 75 yrs.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raghu S Thota, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tata Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tata Memorial Centre</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <zip>400025</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>September 24, 2018</last_update_submitted>
  <last_update_submitted_qc>September 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tata Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Raghu Thota</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Pain</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/NCT03249766
org study id: 1900
nct id: NCT03249766
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Thoracic surgeries are associated with significant operative trauma1. While thoracic epidural
      analgesia may help control the incisional component of the pain, an excruciating
      postthoracotomy. Ipsilateral Shoulder Pain (ISP) could under mine pain management in the post
      thoracotomy patient2. The incidence of ISP ranges from 21% to 97%3. ISP impairs respiration,
      mobility, and physical therapy in the early postoperative period4. The etiology of ISP is
      unclear. Several hypotheses have been proposed as possible causes of ISP, including
      transection of a major bronchus, ligament distraction by surgical retraction, shoulder joint
      strain as a result of intraoperative positioning, pleural irritation due to the thoracostomy
      tube, and referred pain from irritation of the pericardium or mediastinal and diaphragmatic
      surfaces2, 5, 6. ISP is defined as the pain occurring on the operated side of thoracic
      surgeries in the immediate postoperative period as early as one hour after surgery6,of dull
      aching, stabbing, burning, electric or throbbing nature of moderate to severe intensity and
      resistant to treatment, most commonly located in the region of the deltoid muscle or on the
      posterior or superior surface of the arm or above ⅓ of the lateral part of the clavicle on
      the anterior surface of the chest, lasting 3-4 days2, 7-11.The primary objective of this
      study is to find out the prevalence of ISP and the risk factors associated with it.
This will be a prospective observational study, which will be done over a period of one year
      (Upto 250 patients) after approval from ethics committee. The data of the first three months
      will be analysed (Upto 60 patients) and will presented as a thesis for MD (Anaesthesia). It
      will be carried out at Tata Memorial Centre, Mumbai. After Institutional Ethics Committee
      approval, Written informed consent in the language the patient understands the best will be
      obtained undergoing thoracic surgeries where the pleura is opened including Thoracotomy,
      Video Assisted Thoracic Surgeries (VATS). Data over a three months period will be collected.
      Pain at the incisional site and Ipsilateral shoulder pain (ISP) will be assessed separately
      using the numeric rating scale (NRS) during the patients' stay in the postanesthesia care
      unit (PACU) by an independent assessor, at 1 hour, 6 hours and 12 hours after coming to the
      PACU. The characteristics, intensity and pain at shoulder at rest and movement will also be
      assessed. Data including age, sex, BMI, American Society of Anesthesiologists (ASA) physical
      status, diagnosis, side and type of operation, surgical approach, positioning during surgery,
      duration of surgery, type of regional anesthesia, and, in patients with epidural anesthesia,
      level of catheter placement will also be recorded.

      All male & female patients (aged 18-75 years) who undergo thoracic surgeries where the pleura
      is opened including Video Assisted Thoracic Surgeries (VATS)

      EXCLUSION CRITERIA:

        1. presence of preoperative shoulder pain,

        2. preoperative shoulder pathology,

        3. use of analgesics for more than 1 week preoperatively,

        4. inability to understand the numeric rating scale(NRS)scoring system for pain assessment

        5. failure to extubate at the end of surgery.

        6. Patients who haven't given consent

        7. Age < 18yrs and > 75 yrs.

      STATISTICAL ANALYSIS:

      Since the study will be done over a period of twelve months, there is no sample size.

      Continuous variables will be analyzed using independent t-test or Mann Whitney U test as per
      the distribution of the data for continuous variables. Categorical variables will be analyzed
      using Chi-square test or Fisher's exact test. P-value < 0.05 will be considered statistical
      significant. Risk factors of ISP will be analyzed using univariate and multivariate binary
      regression with robust estimates to calculate odds ratio (OR) and their 95% confidence
      interval. A manual stepwise forward logistic regression will be used to extract univariate
      independent variables. A p value ≤ 0.2 by univariate analysis will be used as the criterion
      for choosing variables to be included in the model for multivariate analysis. A p value <0.05
      is considered statistically significant. Cut-off points of the independent variables,
      including age group and duration of surgery, are estimated by the method of maximum
      likelihood to achieve best discrimination between patients with and without ISP.
observational model: Cohort
time perspective: Prospective
measure: Prevalence of Ipsilateral shoulder pain
time frame: Upto 12 hours post surgery
description: Numeric rating scale within 12 hours post operative
intervention type: Other
intervention name: Observational
description: Observational study
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Raghu S Thota, MD
role: Principal Investigator
affiliation: Tata Memorial Hospital
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Tata Memorial Hospital
investigator full name: Raghu Thota
investigator title: Associate Professor
mesh term: Shoulder Pain
sharing ipd: Undecided