Degenerative Disc DiseasePhase 1NCT04112550
Clinical Effectiveness of Pre-operative Methadone in Single Level Lateral Transpsoas Interbody Fusions
A Phase 1 study testing Methadone Hydrochloride and Oxycodone-Acetaminophen in people with Degenerative Disc Disease and Spondylolisthesis, Lumbar Region, run by The Methodist Hospital Research Institute.
Trial summary
Spinal operations including lumbar fusions for degenerative disorders are becoming more prevalent as the population ages. Inadequate or excessive postoperative analgesia can result in medical comorbidities and prolonged hospital length of stay and patient dissatisfaction. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Degenerative Disc Disease, Spondylolisthesis, Lumbar Region
- What is being tested?
- Methadone Hydrochloride and Oxycodone-Acetaminophen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 11 Feb 2020to 31 Dec 2021
- Phase
- Phase 1
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18 - 70
- Will undergo one level minimally invasive lumbar fusion surgery
- Primary symptoms are back and/or leg pain
Who cannot join
- Preoperative chronic renal insufficiency or failure (defined as a serum creatinine more than 2 mg/dl)
- Significant liver disease (cirrhosis or hepatic failure)
- American Society of Anesthesiologists (ASA) physical status IV or V
- Pulmonary disease necessitating home oxygen therapy
- Patients with acute bronchial asthma or hypercarbia
- Patient who has or is suspected of having a paralytic ileus
Show all 16Show fewer
- Preoperative use of methadone or hydromorphone
- Known hypersensitivity to methadone
- Known hypersensitivity to oxycodone
- Recent history of opioid or alcohol abuse
- Inability to use a PCA device
- Inability to speak English
- Any patient judged by the anesthesia care team to potentially require prolonged postoperative intubation
- Participation in another clinical trial
- Inability of patient to provide study informed consent (including patients who are cognitively impaired)
- Presence of drug interaction between methadone/oxycodone and patient's regular or PRN medications
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Effectiveness of Pre-operative Methadone in Single Level Lateral Transpsoas Interbody Fusions: A Randomized, Double-blinded, Controlled Trial
Spinal operations including lumbar fusions for degenerative disorders are becoming more prevalent as the population ages. Inadequate or excessive postoperative analgesia can result in medical comorbidities and prolonged hospital length of stay and patient dissatisfaction.
Existing literature has highlighted the preoperative administration of methadone as a promising adjuvant for post operative pain control. Methadone has the benefit of being long-acting and has more stable serum concentration and a single preoperative dose may have significant benefits post operatively.
Here the investigators propose a prospective parallel-group, randomized, double-blinded study to assess post operative analgesic requirements after preoperative administration of either methadone 15 mg or Oxycodone 10/325. Primary outcome will be total IV and PO narcotic consumption in the post operative course. Secondary outcomes examined will include time to mobility, need for specialist pain management consultation, early readmission (within 2 weeks) for inadequate pain control, and complications associated with administration.
Read the detailed description
Lumbar spinal fusions are becoming increasingly popular and prevalent in the treatment of a variety of spinal pathologies, but predominantly for degenerative disease which is most prevalent in the obese and or older population. These operations can result in relatively high post operative surgical pain and necessitate significant post operative opioid consumption which can precipitate co-morbid medical conditions such as respiratory depression and failure, pneumonia, gastrointestinal ileus, deep venous thrombosis, and pulmonary embolism. Additionally, these medical comorbidities also represent an increased burden on healthcare expenditure with increased length of hospital stay, inpatient testing and treatment, and need for additional follow up.
The investigators objective is to study the effect of a long term opioid analgesic, methadone, in a uniform population undergoing a single level minimally invasive lumbar fusion. The preoperative single dose administration of methadone has already been shown to be effective in improving post operative pain control in open multi-level spinal fusion patient populations and has become the standard of care in most surgical centers across the country. The long half-life of methadone results in improved steady state pharmacokinetics relative to other traditional opioids and is thought to improve pain control while decreasing consumption. In addition to Mu opioid receptor agonism, Methadone is thought to also have adjunctive analgesic and anti-tolerance effects due to CNS excitatory glutamatergic NMDA receptor antagonism. There are also reports of synergistic effects from serotonin and norepinephrine reuptake inhibition.
The investigators predict that a single preoperative oral methadone administration can result in improved postoperative analgesia with requirement of less IV and PO traditional narcotics within the first 2 weeks post operatively and also will not increase co-morbid risks relative to traditional shorter acting opioid analgesics that are presently given preoperatively.
- Being tested
- Methadone Hydrochloride, Oxycodone-Acetaminophen
- Keywords
- lateral lumbar interbody fusion, minimally invasive spinal surgery
- Medical subject headings
- Intervertebral Disc Degeneration, Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methadone HydrochlorideDrug
FDA approved medication to treat pain
Oxycodone-AcetaminophenDrug
FDA approved medication to treat pain
| Study group | Role | What they receive |
|---|---|---|
| Methadone | Active comparator | This cohort will receive oral methadone 15mg po tablet pre-operatively Receives: Drug: Methadone Hydrochloride |
| Oxycodone | Active comparator | This cohort will receive oxycodone/acetaminophen 10/325 po tablet pre-operatively Receives: Drug: Oxycodone-Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative in-hospital patient's narcotic requirement
The total Morphine Milligram Equivalent (MME) for each post-operative day
Measured: Post-operative day 0 to 4
Improvement in low back pain between the two cohorts as assessed by Oswestry Disbility Index (ODI)
Change in ODI (scale from 0 to 100) from pre-op to post-op (14 days post-op)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start11 Feb 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SBarber, The Methodist Hospital Research Institute
- Investigators
- Sean M Barber, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112550
- Sponsor's protocol ID
- Pro00022567
- Status last verified
- Jan 2020
- First submitted
- 27 Sep 2019
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No plans to share IPD at the moment
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of Pre-operative Methadone in Single Level Lateral Transpsoas Interbody Fusions: A Randomized, Double-blinded, Controlled Trial
- ClinicalTrials.gov ID
- NCT04112550
- Acronym / sponsor ID
- Pro00022567
- Keywords
- lateral lumbar interbody fusion, minimally invasive spinal surgery
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 11 Feb 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 2 Oct 2019 (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.
Spinal operations including lumbar fusions for degenerative disorders are becoming more prevalent as the population ages. Inadequate or excessive postoperative analgesia can result in medical comorbidities and prolonged hospital length of stay and patient dissatisfaction.
Existing literature has highlighted the preoperative administration of methadone as a promising adjuvant for post operative pain control. Methadone has the benefit of being long-acting and has more stable serum concentration and a single preoperative dose may have significant benefits post operatively.
Here the investigators propose a prospective parallel-group, randomized, double-blinded study to assess post operative analgesic requirements after preoperative administration of either methadone 15 mg or Oxycodone 10/325. Primary outcome will be total IV and PO narcotic consumption in the post operative course. Secondary outcomes examined will include time to mobility, need for specialist pain management consultation, early readmission (within 2 weeks) for inadequate pain control, and complications associated with administration.
Detailed description
Lumbar spinal fusions are becoming increasingly popular and prevalent in the treatment of a variety of spinal pathologies, but predominantly for degenerative disease which is most prevalent in the obese and or older population. These operations can result in relatively high post operative surgical pain and necessitate significant post operative opioid consumption which can precipitate co-morbid medical conditions such as respiratory depression and failure, pneumonia, gastrointestinal ileus, deep venous thrombosis, and pulmonary embolism. Additionally, these medical comorbidities also represent an increased burden on healthcare expenditure with increased length of hospital stay, inpatient testing and treatment, and need for additional follow up.
The investigators objective is to study the effect of a long term opioid analgesic, methadone, in a uniform population undergoing a single level minimally invasive lumbar fusion. The preoperative single dose administration of methadone has already been shown to be effective in improving post operative pain control in open multi-level spinal fusion patient populations and has become the standard of care in most surgical centers across the country. The long half-life of methadone results in improved steady state pharmacokinetics relative to other traditional opioids and is thought to improve pain control while decreasing consumption. In addition to Mu opioid receptor agonism, Methadone is thought to also have adjunctive analgesic and anti-tolerance effects due to CNS excitatory glutamatergic NMDA receptor antagonism. There are also reports of synergistic effects from serotonin and norepinephrine reuptake inhibition.
The investigators predict that a single preoperative oral methadone administration can result in improved postoperative analgesia with requirement of less IV and PO traditional narcotics within the first 2 weeks post operatively and also will not increase co-morbid risks relative to traditional shorter acting opioid analgesics that are presently given preoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methadone | Active comparator | Drug: Methadone HydrochlorideThis cohort will receive oral methadone 15mg po tablet pre-operatively |
| Oxycodone | Active comparator | Drug: Oxycodone-AcetaminophenThis cohort will receive oxycodone/acetaminophen 10/325 po tablet pre-operatively |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 18 - 70
- Will undergo one level minimally invasive lumbar fusion surgery
- Primary symptoms are back and/or leg pain
Key exclusion criteria (16 listed)
- Preoperative chronic renal insufficiency or failure (defined as a serum creatinine more than 2 mg/dl)
- Significant liver disease (cirrhosis or hepatic failure)
- American Society of Anesthesiologists (ASA) physical status IV or V
- Pulmonary disease necessitating home oxygen therapy
- Patients with acute bronchial asthma or hypercarbia
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 |
|---|---|---|
| Methadone HydrochlorideFDA approved medication to treat pain | Drug | Methadone |
| Oxycodone-AcetaminophenFDA approved medication to treat pain | Drug | Oxycodone |
Primary outcome
Post-operative in-hospital patient's narcotic requirement
Time frame: Post-operative day 0 to 4
The total Morphine Milligram Equivalent (MME) for each post-operative day
Improvement in low back pain between the two cohorts as assessed by Oswestry Disbility Index (ODI)
Time frame: 14 days
Change in ODI (scale from 0 to 100) from pre-op to post-op (14 days post-op)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- Individual participant dataSharing planned: Undecided. No plans to share IPD at the moment
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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.
Sean M Barber, MD principal investigator
The Methodist Hospital Research Institute
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Methadone Hydrochloride and Oxycodone-Acetaminophen in people with Degenerative Disc Disease and Spondylolisthesis, Lumbar Region, run by The Methodist Hospital Research Institute.
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 3 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 29 Jan 2020. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Saeed S Sadrameli, MD, MS (2817431385, ssadrameli@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative in-hospital patient's narcotic requirement (time frame: Post-operative day 0 to 4). The study lists 2 primary outcomes in all. 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 29 Jan 2020; AzTrials last refreshed its copy on 7 Nov 2026.