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Intraoperative Methadone for Postoperative Pain Control

Primary Purpose

Bariatric Surgery Candidate

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Methadone
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bariatric Surgery Candidate focused on measuring methadone, bariatric surgery, pain management

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: • All patients undergoing initial gastric sleeve resection Exclusion Criteria: Age <18 years or >60 years Patients with BMI >60 AHI > 30 (AHI = Apnea-Hypopnea Index), indicative of severe Obstructive Sleep Apnea (OSA) ASA IV or V (American Society of Anesthesiology physical status classification system) Patients taking opioids for chronic conditions in the last 10 days preceding the surgery Patients currently being treated for chronic opioid addiction Patients with severe psychiatric diagnoses Allergies to medications used in protocol

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Methadone group

    Control group

    Arm Description

    Patients in this group will receive intraoperative methadone.

    Patients in this group will receive saline (placebo), instead of methadone

    Outcomes

    Primary Outcome Measures

    Postoperative opioid use
    Postoperative opioid use will be determined by the amount of morphine consumed (milligram morphine equivalents, MME) at 24 hours postoperatively

    Secondary Outcome Measures

    Total Postoperative opioid use
    Total postoperative opioid use will be determined by the total amount of morphine consumed (milligram morphine equivalents, MME) at 48 hours postoperatively and during follow up visit
    Respiratory interventions
    The number of respiratory interventions required postoperatively per patient in the PACU (Post-anesthesia care unit) will be determined
    Duration of hospital stay
    The average duration of hospitalization will be determined per patient
    Patients Perception of Pain Management
    Patients perceptions of pain management will be measured by administration of the International Pain Outcomes (IPO) questionnaire on Post-Operative Day 1 (POD 1). IPO will be used to assess key patient level outcomes of postoperative pain management and consists of 13 questions evaluating four outcome domains: 1) intensity of pain rated on Numeric Rating Scale (NRS) score (0 = no pain, 10 = worst possible pain); 2) interference of pain with activities and emotional well-being as determined by a score analogous to the NRS 0-10 scale above; 3) side effects of pain treatment, including nausea, drowsiness, itching, and dizziness, as determined by the NRS score >0; and 4) perception of care, treatment satisfaction and involvement in pain treatment decision-making on a scale from 0-10. Scores are aggregated per patient with higher overall scores indicative of a worsening perception of pain management.
    Patients Perception of Pain Management
    Patients perceptions of pain management will be measured by administration of the International Pain Outcomes (IPO) questionnaire on POD 1 (Post-Operative Day 1). IPO will be used to assess key patient level outcomes of postoperative pain management and consists of 13 questions evaluating four outcome domains: 1) intensity of pain rated on numeric rating score (0 = no pain, 10 = worst possible pain); 2) interference of pain with activities and emotional well-being as determined by a score analogous to the 0-10 scale above; 3) side effects of pain treatment, including nausea, drowsiness, itching, and dizziness, as determined by the NRS score >0; and 4) perception of care, treatment satisfaction and involvement in pain treatment decision-making on a scale from 0-10. Scores are aggregated per patient with higher overall scores indicative of a worsening perception of pain management.
    Sedation Score (POSS)
    Sedation score will be determined using the Pasero Opioid-induced Sedation Scale (POSS) in the Post-anesthesia Care Unit (PACU) and on the floor. Average scores will be tabulated per patient using a four point numeric rating scale. Scoring is as follows: 1 = Awake and alert; 2 = Slightly drowsy, easily aroused; 3 = Frequently drowsy, arousable, drifts off to sleep during conversation; 4 = Somnolent, minimal or no response to verbal and physical stimulation
    Agitation and Sedation Severity (RASS)
    Agitation and Sedation severity will determined using the Richmond Agitation-Sedation Scale (RASS) in the PACU and on the floor. Average scores will be determined per patient using a numeric rating scale ranging from +4 to -5 where +4 = combative, +3 = very agitated, +2 = agitated, +1 = restless, 0 = alert and calm, -1: = drowsy, -2 = light sedation, -3 = moderate sedation, -4 = deep sedation, and -5 = unarousable. Ideal RASS scores range from -1 to 1.
    Opioid-related side effects
    Opioid related side effects including nausea, vomiting, pruritis, urinary retention, and necessity of supplemental oxygen will be recorded
    Early Mobilization
    The average duration of time to first ambulation after surgery will be recorded per patient
    GI recovery time
    The average duration of time to return of bowel function will be determined per patient
    Adverse events due to procedure or anesthesia
    Procedure related adverse events or adverse events related to anesthesia will be recorded
    Pain Scores
    Pain scores will be assessed by a research assistant blinded to the study group at regular intervals. Numerical pain scores (0=no pain, 10=most pain) will be assigned on an 11 point scale ranging from 0 (no pain) to 10 (most pain). Since most patients who get bariatric surgery are discharged at POD 1, the research assistant will call the patient the morning of POD 2 to assess the pain score if not on the inpatient floor. If the patients are not yet discharged, the pain score will be assessed the morning of POD 2, otherwise pain scores will be collected as detailed in the time frame below.

    Full Information

    First Posted
    October 26, 2022
    Last Updated
    October 16, 2023
    Sponsor
    Montefiore Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05845359
    Brief Title
    Intraoperative Methadone for Postoperative Pain Control
    Official Title
    Randomized Control Study on the Effectiveness of Intraoperative Methadone on Postoperative Pain Control
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    IRB approval never received
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    February 2024 (Anticipated)
    Study Completion Date
    February 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Montefiore Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes

    5. Study Description

    Brief Summary
    To compare patient pain perception and satisfaction as well as opioid-related side effects during inpatient and outpatient care when undergoing bariatric enhanced recovery after surgery protocols with and without methadone.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bariatric Surgery Candidate
    Keywords
    methadone, bariatric surgery, pain management

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Methadone group
    Arm Type
    Experimental
    Arm Description
    Patients in this group will receive intraoperative methadone.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Patients in this group will receive saline (placebo), instead of methadone
    Intervention Type
    Drug
    Intervention Name(s)
    Methadone
    Intervention Description
    One group will receive 10mg of methadone upon induction, while the other will receive a saline solution as placebo. We will see the effectiveness of methadone on postoperative pain management, while monitoring for opioid-related side effects.
    Primary Outcome Measure Information:
    Title
    Postoperative opioid use
    Description
    Postoperative opioid use will be determined by the amount of morphine consumed (milligram morphine equivalents, MME) at 24 hours postoperatively
    Time Frame
    24 hours postoperatively
    Secondary Outcome Measure Information:
    Title
    Total Postoperative opioid use
    Description
    Total postoperative opioid use will be determined by the total amount of morphine consumed (milligram morphine equivalents, MME) at 48 hours postoperatively and during follow up visit
    Time Frame
    48 hours postoperatively and approximately at 2 weeks (follow up visit upon discharge)
    Title
    Respiratory interventions
    Description
    The number of respiratory interventions required postoperatively per patient in the PACU (Post-anesthesia care unit) will be determined
    Time Frame
    Up to 4 hours postoperatively
    Title
    Duration of hospital stay
    Description
    The average duration of hospitalization will be determined per patient
    Time Frame
    Approximately 5 days postoperatively
    Title
    Patients Perception of Pain Management
    Description
    Patients perceptions of pain management will be measured by administration of the International Pain Outcomes (IPO) questionnaire on Post-Operative Day 1 (POD 1). IPO will be used to assess key patient level outcomes of postoperative pain management and consists of 13 questions evaluating four outcome domains: 1) intensity of pain rated on Numeric Rating Scale (NRS) score (0 = no pain, 10 = worst possible pain); 2) interference of pain with activities and emotional well-being as determined by a score analogous to the NRS 0-10 scale above; 3) side effects of pain treatment, including nausea, drowsiness, itching, and dizziness, as determined by the NRS score >0; and 4) perception of care, treatment satisfaction and involvement in pain treatment decision-making on a scale from 0-10. Scores are aggregated per patient with higher overall scores indicative of a worsening perception of pain management.
    Time Frame
    24 hours postoperatively
    Title
    Patients Perception of Pain Management
    Description
    Patients perceptions of pain management will be measured by administration of the International Pain Outcomes (IPO) questionnaire on POD 1 (Post-Operative Day 1). IPO will be used to assess key patient level outcomes of postoperative pain management and consists of 13 questions evaluating four outcome domains: 1) intensity of pain rated on numeric rating score (0 = no pain, 10 = worst possible pain); 2) interference of pain with activities and emotional well-being as determined by a score analogous to the 0-10 scale above; 3) side effects of pain treatment, including nausea, drowsiness, itching, and dizziness, as determined by the NRS score >0; and 4) perception of care, treatment satisfaction and involvement in pain treatment decision-making on a scale from 0-10. Scores are aggregated per patient with higher overall scores indicative of a worsening perception of pain management.
    Time Frame
    2 days postoperatively
    Title
    Sedation Score (POSS)
    Description
    Sedation score will be determined using the Pasero Opioid-induced Sedation Scale (POSS) in the Post-anesthesia Care Unit (PACU) and on the floor. Average scores will be tabulated per patient using a four point numeric rating scale. Scoring is as follows: 1 = Awake and alert; 2 = Slightly drowsy, easily aroused; 3 = Frequently drowsy, arousable, drifts off to sleep during conversation; 4 = Somnolent, minimal or no response to verbal and physical stimulation
    Time Frame
    2 days postoperatively
    Title
    Agitation and Sedation Severity (RASS)
    Description
    Agitation and Sedation severity will determined using the Richmond Agitation-Sedation Scale (RASS) in the PACU and on the floor. Average scores will be determined per patient using a numeric rating scale ranging from +4 to -5 where +4 = combative, +3 = very agitated, +2 = agitated, +1 = restless, 0 = alert and calm, -1: = drowsy, -2 = light sedation, -3 = moderate sedation, -4 = deep sedation, and -5 = unarousable. Ideal RASS scores range from -1 to 1.
    Time Frame
    2 days postoperatively
    Title
    Opioid-related side effects
    Description
    Opioid related side effects including nausea, vomiting, pruritis, urinary retention, and necessity of supplemental oxygen will be recorded
    Time Frame
    Up to 2 days postoperatively
    Title
    Early Mobilization
    Description
    The average duration of time to first ambulation after surgery will be recorded per patient
    Time Frame
    Up to 2 days postoperatively
    Title
    GI recovery time
    Description
    The average duration of time to return of bowel function will be determined per patient
    Time Frame
    Up to 2 days postoperatively
    Title
    Adverse events due to procedure or anesthesia
    Description
    Procedure related adverse events or adverse events related to anesthesia will be recorded
    Time Frame
    Up to 2 days postoperatively
    Title
    Pain Scores
    Description
    Pain scores will be assessed by a research assistant blinded to the study group at regular intervals. Numerical pain scores (0=no pain, 10=most pain) will be assigned on an 11 point scale ranging from 0 (no pain) to 10 (most pain). Since most patients who get bariatric surgery are discharged at POD 1, the research assistant will call the patient the morning of POD 2 to assess the pain score if not on the inpatient floor. If the patients are not yet discharged, the pain score will be assessed the morning of POD 2, otherwise pain scores will be collected as detailed in the time frame below.
    Time Frame
    After 30 minutes in the PACU; upon discharge from PACU (variable timepoint); at 6, 12, 18, and 24 hours after being on the in-patient floor; and at hospital discharge

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: • All patients undergoing initial gastric sleeve resection Exclusion Criteria: Age <18 years or >60 years Patients with BMI >60 AHI > 30 (AHI = Apnea-Hypopnea Index), indicative of severe Obstructive Sleep Apnea (OSA) ASA IV or V (American Society of Anesthesiology physical status classification system) Patients taking opioids for chronic conditions in the last 10 days preceding the surgery Patients currently being treated for chronic opioid addiction Patients with severe psychiatric diagnoses Allergies to medications used in protocol
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jennifer Choi, MD
    Organizational Affiliation
    Montefiore Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Intraoperative Methadone for Postoperative Pain Control

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