Intraoperative Methadone for Postoperative Pain Control
- Registration Number
- NCT05845359
- Lead Sponsor
- Montefiore Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
• All patients undergoing initial gastric sleeve resection
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Methadone group Methadone Patients in this group will receive intraoperative methadone.
- Primary Outcome Measures
Name Time Method Postoperative opioid use 24 hours postoperatively Postoperative opioid use will be determined by the amount of morphine consumed (milligram morphine equivalents, MME) at 24 hours postoperatively
- Secondary Outcome Measures
Name Time Method Total Postoperative opioid use 48 hours postoperatively and approximately at 2 weeks (follow up visit upon discharge) 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
Opioid-related side effects Up to 2 days postoperatively Opioid related side effects including nausea, vomiting, pruritis, urinary retention, and necessity of supplemental oxygen will be recorded
Pain Scores 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 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.
Duration of hospital stay Approximately 5 days postoperatively The average duration of hospitalization will be determined per patient
Sedation Score (POSS) 2 days postoperatively 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) 2 days postoperatively 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.
Early Mobilization Up to 2 days postoperatively The average duration of time to first ambulation after surgery will be recorded per patient
Adverse events due to procedure or anesthesia Up to 2 days postoperatively Procedure related adverse events or adverse events related to anesthesia will be recorded
Respiratory interventions Up to 4 hours postoperatively The number of respiratory interventions required postoperatively per patient in the PACU (Post-anesthesia care unit) will be determined
Patients Perception of Pain Management 2 days postoperatively 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.
GI recovery time Up to 2 days postoperatively The average duration of time to return of bowel function will be determined per patient