<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/NCT03266445</url>
  </required_header>
  <id_info>
    <org_study_id>2017P001425</org_study_id>
    <nct_id>NCT03266445</nct_id>
  </id_info>
  <brief_title>Effect of Buprenorphine/Naloxone Continuation on Pain Control and Opioid Use</brief_title>
  <official_title>A Prospective, Randomized Trial of the Effect of Standard of Care Reduced Dose Versus Full Dose Buprenorphine/Naloxone in the Perioperative Period on Pain Control and Post Operative Opioid Use Disorder Symptoms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to determine the effect of continuation of buprenorphine/naloxone in&#xD;
      patients with history of Opioid Use Disorder (OUD) scheduled for surgery compared to reduced&#xD;
      dose buprenorphine/naloxone prior to surgery on pain scores, opioid consumption, depressive&#xD;
      symptoms and severity of substance use dependence- including record of problematic use of any&#xD;
      non-prescribed opioids, alcohol and illicit narcotics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Opioid use disorder (OUD) is characterized by non-remitting cycles of remission and opioid&#xD;
      abuse relapse. It is associated with a high rate of psychiatric and physical co-morbidity&#xD;
      when left untreated. Buprenorphine and buprenorphine/naloxone are effective opioid&#xD;
      maintenance therapy (OMT) for OUD, however, treatment of acute post-surgical pain in patients&#xD;
      taking buprenorphine is perceived to be challenging. Although not substantiated in clinical&#xD;
      studies, the combination of high receptor binding affinity, long half-life, and partial mu&#xD;
      opioid receptor agonism with buprenorphine/naloxone are thought to inhibit the analgesic&#xD;
      actions of full mu opioid receptor agonists, potentially making standard postoperative pain&#xD;
      control strategies less effective. There is no evidence based standard of care for optimal&#xD;
      acute pain management strategies for patients taking buprenorphine and most recommendations&#xD;
      are based upon provider opinion- occasionally conflicting along specialty lines. Some&#xD;
      providers, mainly consisting of surgeons and anesthesiologists, recommend that buprenorphine&#xD;
      should be discontinued at least 72 hours prior to elective surgery and replaced with low dose&#xD;
      opioid agonists, in the interim. Other providers, mainly comprising of psychiatrists, contend&#xD;
      that these patients should be maintained on buprenorphine throughout the peri-operative&#xD;
      period at either a full or reduced dose to prevent an indeterminate risk of substance abuse&#xD;
      relapse that can occur as consequence to the abrupt termination buprenorphine in the highly&#xD;
      stressful surgical period. This study aims to inform this important unresolved question in&#xD;
      the clinical care of this growing population. The investigators seek to determine the&#xD;
      effectiveness of managing postoperative pain in patients with OUD where&#xD;
      buprenorphine/naloxone is continued perioperatively compared to patients where&#xD;
      buprenorphine/naloxone is reduced to a lower dose. Longitudinally, the investigators also&#xD;
      intend to determine if there is a difference in substance abuse relapse in patients where&#xD;
      buprenorphine/naloxone is continued vs. held by using self assessments and communication with&#xD;
      the participant's buprenorphine provider.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 5, 2018</start_date>
  <completion_date type="Anticipated">February 26, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <phase>Phase 4</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>
    <intervention_model_description>Participants will be randomly assigned to be maintained on their daily dose of buprenorphine/naloxone or to have their buprenorphine/naloxone reduced to 8mg prior to surgery. Each group will have identical perioperative treatment plans. Primary outcome measured is pain scores following surgery.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post-operative pain scores</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>Level of pain on a Visual Analog Scale of 0-100 (0=no pain; 100=worst pain imaginable) This scale will be used to quantify the varying degrees of pain or discomfort experienced by the participant.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative opioid consumption</measure>
    <time_frame>24 hours, 48 hours and 72 hours after surgery</time_frame>
    <description>Amount of opioids needed for pain control postoperatively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative pain scores</measure>
    <time_frame>48 hours, 72 hours after surgery</time_frame>
    <description>Level of pain on Visual Analog Scale 0-100 (0= no pain 100= worst pain imaginable) We will compare the results of the 48 and 72 hour time-points with the 24 hour time-point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence, severity of substance abuse</measure>
    <time_frame>1 month after surgery</time_frame>
    <description>Participants will complete questionnaires to identify the presence and severity of substance abuse.These values will be compared with baseline values obtained preoperatively.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">76</enrollment>
  <condition>Opioid-use Disorder</condition>
  <condition>Pain, Acute</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>FULL-BUPRENORPHINE</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will be randomly assigned to be maintained on their daily dose of buprenorphine/naloxone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LOW-BUPRENORPHINE (control)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will be randomly assigned to have their daily dose of buprenorphine/naloxone reduced to 8mg on the day of surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>buprenorphine/naloxone</intervention_name>
    <description>The intervention will be to either continue taking buprenorphine/naloxone or to have the medication reduced perioperatively.</description>
    <arm_group_label>FULL-BUPRENORPHINE</arm_group_label>
    <other_name>Reduction vs Continuation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  currently taking buprenorphine or buprenorphine/naloxone daily for treatment of opioid&#xD;
             use disorder by DSM-V criteria&#xD;
&#xD;
          -  on buprenorphine or buprenorphine/naloxone dose of greater than 8mg for at least 30&#xD;
             days&#xD;
&#xD;
          -  ASA health class I-III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to consent to the study&#xD;
&#xD;
          -  Significant pulmonary or cardiac disease&#xD;
&#xD;
          -  Renal insufficiency with a glomerular filtration rate less than 30ml/min&#xD;
&#xD;
          -  Liver cirrhosis with a Model for End-Stage Liver Disease (MELD) score of greater than&#xD;
             25&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aurora Quaye, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Aurora Quaye, MD</last_name>
    <phone>617-726-2000</phone>
    <email>aquaye@partners.org</email>
  </overall_contact>
  <link>
    <url>https://www.samhsa.gov/data/sites/default/files/NSDUH-FRR1-2014/NSDUH-FRR1-2014.pdf</url>
    <description>Center for Behavioral Health Statistics and Quality. Behavioral health trends in the United States: Results from the 2014 National Survey on Drug Use and Health. 2015. HHS Publication No. SMA 15-4927, NSDUH Series H-50.</description>
  </link>
  <reference>
    <citation>McLellan AT, Lewis DC, O'Brien CP, Kleber HD. Drug dependence, a chronic medical illness: implications for treatment, insurance, and outcomes evaluation. JAMA. 2000 Oct 4;284(13):1689-95. doi: 10.1001/jama.284.13.1689.</citation>
    <PMID>11015800</PMID>
  </reference>
  <reference>
    <citation>Scott CK, Dennis ML, Laudet A, Funk RR, Simeone RS. Surviving drug addiction: the effect of treatment and abstinence on mortality. Am J Public Health. 2011 Apr;101(4):737-44. doi: 10.2105/AJPH.2010.197038. Epub 2011 Feb 17.</citation>
    <PMID>21330586</PMID>
  </reference>
  <reference>
    <citation>Degenhardt L, Bucello C, Mathers B, Briegleb C, Ali H, Hickman M, McLaren J. Mortality among regular or dependent users of heroin and other opioids: a systematic review and meta-analysis of cohort studies. Addiction. 2011 Jan;106(1):32-51. doi: 10.1111/j.1360-0443.2010.03140.x. Epub 2010 Nov 4.</citation>
    <PMID>21054613</PMID>
  </reference>
  <reference>
    <citation>Schuckit MA. Treatment of Opioid-Use Disorders. N Engl J Med. 2016 Jul 28;375(4):357-68. doi: 10.1056/NEJMra1604339. No abstract available.</citation>
    <PMID>27464203</PMID>
  </reference>
  <reference>
    <citation>Gordon AJ, Lo-Ciganic WH, Cochran G, Gellad WF, Cathers T, Kelley D, Donohue JM. Patterns and Quality of Buprenorphine Opioid Agonist Treatment in a Large Medicaid Program. J Addict Med. 2015 Nov-Dec;9(6):470-7. doi: 10.1097/ADM.0000000000000164.</citation>
    <PMID>26517324</PMID>
  </reference>
  <reference>
    <citation>Roberts DM, Meyer-Witting M. High-dose buprenorphine: perioperative precautions and management strategies. Anaesth Intensive Care. 2005 Feb;33(1):17-25. doi: 10.1177/0310057X0503300104.</citation>
    <PMID>15957687</PMID>
  </reference>
  <reference>
    <citation>Bryson EO. The perioperative management of patients maintained on medications used to manage opioid addiction. Curr Opin Anaesthesiol. 2014 Jun;27(3):359-64. doi: 10.1097/ACO.0000000000000052.</citation>
    <PMID>24500338</PMID>
  </reference>
  <reference>
    <citation>McCormick Z, Chu SK, Chang-Chien GC, Joseph P. Acute pain control challenges with buprenorphine/naloxone therapy in a patient with compartment syndrome secondary to McArdle's disease: a case report and review. Pain Med. 2013 Aug;14(8):1187-91. doi: 10.1111/pme.12135. Epub 2013 May 3.</citation>
    <PMID>23647815</PMID>
  </reference>
  <reference>
    <citation>Huang A, Katznelson R, de Perrot M, Clarke H. Perioperative management of a patient undergoing Clagett window closure stabilized on Suboxone(R) for chronic pain: a case report. Can J Anaesth. 2014 Sep;61(9):826-31. doi: 10.1007/s12630-014-0193-y. Epub 2014 Jul 2.</citation>
    <PMID>24985936</PMID>
  </reference>
  <reference>
    <citation>Kornfeld H, Manfredi L. Effectiveness of full agonist opioids in patients stabilized on buprenorphine undergoing major surgery: a case series. Am J Ther. 2010 Sep-Oct;17(5):523-8. doi: 10.1097/MJT.0b013e3181be0804.</citation>
    <PMID>19918165</PMID>
  </reference>
  <reference>
    <citation>Macintyre PE, Russell RA, Usher KA, Gaughwin M, Huxtable CA. Pain relief and opioid requirements in the first 24 hours after surgery in patients taking buprenorphine and methadone opioid substitution therapy. Anaesth Intensive Care. 2013 Mar;41(2):222-30. doi: 10.1177/0310057X1304100212.</citation>
    <PMID>23530789</PMID>
  </reference>
  <reference>
    <citation>Kelly AM. The minimum clinically significant difference in visual analogue scale pain score does not differ with severity of pain. Emerg Med J. 2001 May;18(3):205-7. doi: 10.1136/emj.18.3.205.</citation>
    <PMID>11354213</PMID>
  </reference>
  <reference>
    <citation>Wilkinson KM, Krige A, Brearley SG, Lane S, Scott M, Gordon AC, Carlson GL. Thoracic Epidural analgesia versus Rectus Sheath Catheters for open midline incisions in major abdominal surgery within an enhanced recovery programme (TERSC): study protocol for a randomised controlled trial. Trials. 2014 Oct 21;15:400. doi: 10.1186/1745-6215-15-400.</citation>
    <PMID>25336055</PMID>
  </reference>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>October 5, 2018</last_update_submitted>
  <last_update_submitted_qc>October 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Aurora Naa-Afoley Quaye</investigator_full_name>
    <investigator_title>Instructor M.D.</investigator_title>
  </responsible_party>
  <keyword>relapse</keyword>
  <keyword>buprenorphine/naloxone</keyword>
  <keyword>opioids</keyword>
  <keyword>narcotics</keyword>
  <keyword>post-surgical pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Pain</mesh_term>
    <mesh_term>Opioid-Related Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Buprenorphine</mesh_term>
    <mesh_term>Buprenorphine, Naloxone Drug Combination</mesh_term>
    <mesh_term>Naloxone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>IPD will only be available to researchers involved in the study. All data will be collected and stored securely using the Redcap system to preserve privacy and confidentiality. Information regarding substance abuse history, including illicit narcotic use, will remain confidential and personal identifiers will be removed during data storage. Only members of the research team will have access to the data that participants have consented to provide. Participants will be informed that they have the right to not answer any question that makes them feel uncomfortable.</ipd_description>
  </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/NCT03266445
org study id: 2017P001425
nct id: NCT03266445
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The aim of this study is to determine the effect of continuation of buprenorphine/naloxone in
      patients with history of Opioid Use Disorder (OUD) scheduled for surgery compared to reduced
      dose buprenorphine/naloxone prior to surgery on pain scores, opioid consumption, depressive
      symptoms and severity of substance use dependence- including record of problematic use of any
      non-prescribed opioids, alcohol and illicit narcotics.
Opioid use disorder (OUD) is characterized by non-remitting cycles of remission and opioid
      abuse relapse. It is associated with a high rate of psychiatric and physical co-morbidity
      when left untreated. Buprenorphine and buprenorphine/naloxone are effective opioid
      maintenance therapy (OMT) for OUD, however, treatment of acute post-surgical pain in patients
      taking buprenorphine is perceived to be challenging. Although not substantiated in clinical
      studies, the combination of high receptor binding affinity, long half-life, and partial mu
      opioid receptor agonism with buprenorphine/naloxone are thought to inhibit the analgesic
      actions of full mu opioid receptor agonists, potentially making standard postoperative pain
      control strategies less effective. There is no evidence based standard of care for optimal
      acute pain management strategies for patients taking buprenorphine and most recommendations
      are based upon provider opinion- occasionally conflicting along specialty lines. Some
      providers, mainly consisting of surgeons and anesthesiologists, recommend that buprenorphine
      should be discontinued at least 72 hours prior to elective surgery and replaced with low dose
      opioid agonists, in the interim. Other providers, mainly comprising of psychiatrists, contend
      that these patients should be maintained on buprenorphine throughout the peri-operative
      period at either a full or reduced dose to prevent an indeterminate risk of substance abuse
      relapse that can occur as consequence to the abrupt termination buprenorphine in the highly
      stressful surgical period. This study aims to inform this important unresolved question in
      the clinical care of this growing population. The investigators seek to determine the
      effectiveness of managing postoperative pain in patients with OUD where
      buprenorphine/naloxone is continued perioperatively compared to patients where
      buprenorphine/naloxone is reduced to a lower dose. Longitudinally, the investigators also
      intend to determine if there is a difference in substance abuse relapse in patients where
      buprenorphine/naloxone is continued vs. held by using self assessments and communication with
      the participant's buprenorphine provider.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomly assigned to be maintained on their daily dose of buprenorphine/naloxone or to have their buprenorphine/naloxone reduced to 8mg prior to surgery. Each group will have identical perioperative treatment plans. Primary outcome measured is pain scores following surgery.
primary purpose: Treatment
masking: None (Open Label)
measure: Post-operative pain scores
time frame: 24 hours after surgery
description: Level of pain on a Visual Analog Scale of 0-100 (0=no pain; 100=worst pain imaginable) This scale will be used to quantify the varying degrees of pain or discomfort experienced by the participant.
measure: Postoperative opioid consumption
time frame: 24 hours, 48 hours and 72 hours after surgery
description: Amount of opioids needed for pain control postoperatively
measure: Post-operative pain scores
time frame: 48 hours, 72 hours after surgery
description: Level of pain on Visual Analog Scale 0-100 (0= no pain 100= worst pain imaginable) We will compare the results of the 48 and 72 hour time-points with the 24 hour time-point.
measure: Presence, severity of substance abuse
time frame: 1 month after surgery
description: Participants will complete questionnaires to identify the presence and severity of substance abuse.These values will be compared with baseline values obtained preoperatively.
arm group label: FULL-BUPRENORPHINE
arm group type: Active Comparator
description: Participants will be randomly assigned to be maintained on their daily dose of buprenorphine/naloxone
arm group label: LOW-BUPRENORPHINE (control)
arm group type: No Intervention
description: Participants will be randomly assigned to have their daily dose of buprenorphine/naloxone reduced to 8mg on the day of surgery
intervention type: Drug
intervention name: buprenorphine/naloxone
description: The intervention will be to either continue taking buprenorphine/naloxone or to have the medication reduced perioperatively.
arm group label: FULL-BUPRENORPHINE
other name: Reduction vs Continuation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Aurora Quaye, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
last name: Aurora Quaye, MD
phone: 617-726-2000
email: aquaye@partners.org
url: https://www.samhsa.gov/data/sites/default/files/NSDUH-FRR1-2014/NSDUH-FRR1-2014.pdf
description: Center for Behavioral Health Statistics and Quality. Behavioral health trends in the United States: Results from the 2014 National Survey on Drug Use and Health. 2015. HHS Publication No. SMA 15-4927, NSDUH Series H-50.
citation: McLellan AT, Lewis DC, O'Brien CP, Kleber HD. Drug dependence, a chronic medical illness: implications for treatment, insurance, and outcomes evaluation. JAMA. 2000 Oct 4;284(13):1689-95. doi: 10.1001/jama.284.13.1689.
PMID: 11015800
citation: Scott CK, Dennis ML, Laudet A, Funk RR, Simeone RS. Surviving drug addiction: the effect of treatment and abstinence on mortality. Am J Public Health. 2011 Apr;101(4):737-44. doi: 10.2105/AJPH.2010.197038. Epub 2011 Feb 17.
PMID: 21330586
citation: Degenhardt L, Bucello C, Mathers B, Briegleb C, Ali H, Hickman M, McLaren J. Mortality among regular or dependent users of heroin and other opioids: a systematic review and meta-analysis of cohort studies. Addiction. 2011 Jan;106(1):32-51. doi: 10.1111/j.1360-0443.2010.03140.x. Epub 2010 Nov 4.
PMID: 21054613
citation: Schuckit MA. Treatment of Opioid-Use Disorders. N Engl J Med. 2016 Jul 28;375(4):357-68. doi: 10.1056/NEJMra1604339. No abstract available.
PMID: 27464203
citation: Gordon AJ, Lo-Ciganic WH, Cochran G, Gellad WF, Cathers T, Kelley D, Donohue JM. Patterns and Quality of Buprenorphine Opioid Agonist Treatment in a Large Medicaid Program. J Addict Med. 2015 Nov-Dec;9(6):470-7. doi: 10.1097/ADM.0000000000000164.
PMID: 26517324
citation: Roberts DM, Meyer-Witting M. High-dose buprenorphine: perioperative precautions and management strategies. Anaesth Intensive Care. 2005 Feb;33(1):17-25. doi: 10.1177/0310057X0503300104.
PMID: 15957687
citation: Bryson EO. The perioperative management of patients maintained on medications used to manage opioid addiction. Curr Opin Anaesthesiol. 2014 Jun;27(3):359-64. doi: 10.1097/ACO.0000000000000052.
PMID: 24500338
citation: McCormick Z, Chu SK, Chang-Chien GC, Joseph P. Acute pain control challenges with buprenorphine/naloxone therapy in a patient with compartment syndrome secondary to McArdle's disease: a case report and review. Pain Med. 2013 Aug;14(8):1187-91. doi: 10.1111/pme.12135. Epub 2013 May 3.
PMID: 23647815
citation: Huang A, Katznelson R, de Perrot M, Clarke H. Perioperative management of a patient undergoing Clagett window closure stabilized on Suboxone(R) for chronic pain: a case report. Can J Anaesth. 2014 Sep;61(9):826-31. doi: 10.1007/s12630-014-0193-y. Epub 2014 Jul 2.
PMID: 24985936
citation: Kornfeld H, Manfredi L. Effectiveness of full agonist opioids in patients stabilized on buprenorphine undergoing major surgery: a case series. Am J Ther. 2010 Sep-Oct;17(5):523-8. doi: 10.1097/MJT.0b013e3181be0804.
PMID: 19918165
citation: Macintyre PE, Russell RA, Usher KA, Gaughwin M, Huxtable CA. Pain relief and opioid requirements in the first 24 hours after surgery in patients taking buprenorphine and methadone opioid substitution therapy. Anaesth Intensive Care. 2013 Mar;41(2):222-30. doi: 10.1177/0310057X1304100212.
PMID: 23530789
citation: Kelly AM. The minimum clinically significant difference in visual analogue scale pain score does not differ with severity of pain. Emerg Med J. 2001 May;18(3):205-7. doi: 10.1136/emj.18.3.205.
PMID: 11354213
citation: Wilkinson KM, Krige A, Brearley SG, Lane S, Scott M, Gordon AC, Carlson GL. Thoracic Epidural analgesia versus Rectus Sheath Catheters for open midline incisions in major abdominal surgery within an enhanced recovery programme (TERSC): study protocol for a randomised controlled trial. Trials. 2014 Oct 21;15:400. doi: 10.1186/1745-6215-15-400.
PMID: 25336055
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Aurora Naa-Afoley Quaye
investigator title: Instructor M.D.
mesh term: Acute Pain
mesh term: Opioid-Related Disorders
mesh term: Buprenorphine
mesh term: Buprenorphine, Naloxone Drug Combination
mesh term: Naloxone
sharing ipd: No
ipd description: IPD will only be available to researchers involved in the study. All data will be collected and stored securely using the Redcap system to preserve privacy and confidentiality. Information regarding substance abuse history, including illicit narcotic use, will remain confidential and personal identifiers will be removed during data storage. Only members of the research team will have access to the data that participants have consented to provide. Participants will be informed that they have the right to not answer any question that makes them feel uncomfortable.