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Bariatric Surgery CandidatePhase 4NCT05845359

Intraoperative Methadone for Postoperative Pain Control

A Phase 4 study testing Methadone in people with Bariatric Surgery Candidate, run by Montefiore Medical Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Bariatric Surgery Candidate
What is being tested?
Methadone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Sep 2023to Feb 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • All patients undergoing initial gastric sleeve resection

Who cannot join

  • 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

About this study

Official title: Randomized Control Study on the Effectiveness of Intraoperative Methadone on Postoperative Pain Control

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.

Being tested
Methadone
Keywords
methadone, bariatric surgery, pain management
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MethadoneDrug

    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.

Study groups in NCT05845359
Study groupRoleWhat they receive
Methadone groupExperimentalPatients in this group will receive intraoperative methadone.
Receives: Drug: Methadone
Control groupNo interventionPatients in this group will receive saline (placebo), instead of methadone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative opioid use

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

    Measured: 24 hours postoperatively

Secondary outcomes (12)
  1. 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

    Measured: 48 hours postoperatively and approximately at 2 weeks (follow up visit upon discharge)

  2. Respiratory interventions

    The number of respiratory interventions required postoperatively per patient in the PACU (Post-anesthesia care unit) will be determined

    Measured: Up to 4 hours postoperatively

  3. Duration of hospital stay

    The average duration of hospitalization will be determined per patient

    Measured: Approximately 5 days postoperatively

  4. 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.

    Measured: 24 hours postoperatively

  5. 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.

    Measured: 2 days postoperatively

  6. 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

    Measured: 2 days postoperatively

  7. 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.

    Measured: 2 days postoperatively

  8. Opioid-related side effects

    Opioid related side effects including nausea, vomiting, pruritis, urinary retention, and necessity of supplemental oxygen will be recorded

    Measured: Up to 2 days postoperatively

  9. Early Mobilization

    The average duration of time to first ambulation after surgery will be recorded per patient

    Measured: Up to 2 days postoperatively

  10. GI recovery time

    The average duration of time to return of bowel function will be determined per patient

    Measured: Up to 2 days postoperatively

  11. Adverse events due to procedure or anesthesia

    Procedure related adverse events or adverse events related to anesthesia will be recorded

    Measured: Up to 2 days postoperatively

  12. 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.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2023
  2. Study startSep 2023 (estimated)
  3. Primary completionFeb 2024 (estimated)
  4. Study completionFeb 2024 (estimated)

Why it stopped: IRB approval never received

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05845359
Sponsor's protocol ID
2022-14040
Status last verified
Oct 2023
First submitted
26 Oct 2022
Last updated
18 Oct 2023
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Methadone in people with Bariatric Surgery Candidate, run by Montefiore Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative opioid use (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.

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