A Phase 4 interventional study of Methadone in Bariatric Surgery Candidate, sponsored by Montefiore Medical Center. Withdrawn. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-10-18.
Sponsored by Montefiore Medical Center · Phase 4, Interventional, and Treatment
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
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Of its 81 completed or terminated interventional studies of FDA-regulated products, 73 (90%) have results posted.
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Exclusion Criteria:
Patients in this group will receive intraoperative methadone.
Drug: Methadone
Patients in this group will receive saline (placebo), instead of methadone
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.
Postoperative opioid use
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
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
Time frame: 48 hours postoperatively and approximately at 2 weeks (follow up visit upon discharge)
Respiratory interventions
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
Duration of hospital stay
The average duration of hospitalization will be determined per patient
Time frame: Approximately 5 days postoperatively
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.
Time frame: 24 hours postoperatively
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.
Time frame: 2 days postoperatively
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
Time frame: 2 days postoperatively
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.
Time frame: 2 days postoperatively
Opioid-related side effects
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
Early Mobilization
The average duration of time to first ambulation after surgery will be recorded per patient
Time frame: Up to 2 days postoperatively
GI recovery time
The average duration of time to return of bowel function will be determined per patient
Time frame: Up to 2 days postoperatively
Adverse events due to procedure or anesthesia
Procedure related adverse events or adverse events related to anesthesia will be recorded
Time frame: Up to 2 days postoperatively
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.
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
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