Bariatric Surgery Candidate
Conditions
Keywords
methadone, bariatric surgery, pain management
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.
Interventions
DRUGMethadone
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.
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Duration of hospital stay | Approximately 5 days postoperatively | The average duration of hospitalization will be determined per patient |
| Patients Perception of Pain Management | 24 hours postoperatively | 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. |
| 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. |
| 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 |
| Early Mobilization | Up to 2 days postoperatively | The average duration of time to first ambulation after surgery will be recorded per patient |
| GI recovery time | Up to 2 days postoperatively | The average duration of time to return of bowel function will be determined 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 |
| 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. |
| 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 |
Outcome results
None listed