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.
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.
- Conditions
- Bariatric Surgery Candidate
- 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 group | Role | What they receive |
|---|---|---|
| Methadone group | Experimental | Patients in this group will receive intraoperative methadone. Receives: Drug: Methadone |
| Control group | No intervention | Patients 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.
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)
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)
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
Duration of hospital stay
The average duration of hospitalization will be determined per patient
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: Up to 2 days postoperatively
Early Mobilization
The average duration of time to first ambulation after surgery will be recorded per patient
Measured: Up to 2 days postoperatively
GI recovery time
The average duration of time to return of bowel function will be determined per patient
Measured: 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
Measured: 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.
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.
- First posted6 May 2023
- Study startSep 2023 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (estimated)
Why it stopped: IRB approval never received
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Choi, MD, Principal investigator, Montefiore Medical Center
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Study on the Effectiveness of Intraoperative Methadone on Postoperative Pain Control
- ClinicalTrials.gov ID
- NCT05845359
- Acronym / sponsor ID
- 2022-14040
- Conditions
- Bariatric Surgery Candidate
- Keywords
- methadone, bariatric surgery, pain management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: IRB approval never received
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methadone group | Experimental | Drug: MethadonePatients in this group will receive intraoperative methadone. |
| Control group | No intervention | –Patients in this group will receive saline (placebo), instead of methadone |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All patients undergoing initial gastric sleeve resection
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethadoneOne 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. | Drug | Methadone group |
Primary outcome
Postoperative opioid use
Time frame: 24 hours postoperatively
Postoperative opioid use will be determined by the amount of morphine consumed (milligram morphine equivalents, MME) at 24 hours postoperatively
12 secondary outcomes
Total Postoperative opioid use
Time frame: 48 hours postoperatively and approximately at 2 weeks (follow up visit upon discharge)
Respiratory interventions
Time frame: Up to 4 hours postoperatively
Duration of hospital stay
Time frame: Approximately 5 days postoperatively
Patients Perception of Pain Management
Time frame: 24 hours postoperatively
Patients Perception of Pain Management
Time frame: 2 days postoperatively
Sedation Score (POSS)
Time frame: 2 days postoperatively
Agitation and Sedation Severity (RASS)
Time frame: 2 days postoperatively
Opioid-related side effects
Time frame: Up to 2 days postoperatively
Early Mobilization
Time frame: Up to 2 days postoperatively
GI recovery time
Time frame: Up to 2 days postoperatively
Adverse events due to procedure or anesthesia
Time frame: Up to 2 days postoperatively
Pain Scores
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Choi, MD principal investigator
Montefiore Medical Center
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.