- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04112550
Clinical Effectiveness of Pre-operative Methadone in Single Level Lateral Transpsoas Interbody Fusions
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 1
Kontakter og lokationer
Studiekontakt
- Navn: Saeed S Sadrameli, MD, MS
- Telefonnummer: 2817431385
- E-mail: ssadrameli@houstonmethodist.org
Undersøgelse Kontakt Backup
- Navn: Marcus S Wong, MD
- Telefonnummer: 8324574452
- E-mail: mswong@houstonmethodist.org
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Age: 18 - 70
- Will undergo one level minimally invasive lumbar fusion surgery
- Primary symptoms are back and/or leg pain
Exclusion Criteria:
- 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
- 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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Methadone
This cohort will receive oral methadone 15mg po tablet pre-operatively
|
FDA approved medication to treat pain
|
Aktiv komparator: Oxycodone
This cohort will receive oxycodone/acetaminophen 10/325 po tablet pre-operatively
|
FDA approved medication to treat pain
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Post-operative in-hospital patient's narcotic requirement
Tidsramme: Post-operative day 0 to 4
|
The total Morphine Milligram Equivalent (MME) for each post-operative day
|
Post-operative day 0 to 4
|
Improvement in low back pain between the two cohorts as assessed by Oswestry Disbility Index (ODI)
Tidsramme: 14 days
|
Change in ODI (scale from 0 to 100) from pre-op to post-op (14 days post-op)
|
14 days
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Sean M Barber, MD, The Methodist Hospital Research Institute
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Muskuloskeletale sygdomme
- Rygmarvssygdomme
- Knoglesygdomme
- Spondylolyse
- Spondylose
- Intervertebral diskdegeneration
- Spondylolistese
- Lægemidlers fysiologiske virkninger
- Depressive midler til centralnervesystemet
- Agenter fra det perifere nervesystem
- Analgetika
- Sensoriske systemagenter
- Anti-inflammatoriske midler, ikke-steroide
- Analgetika, ikke-narkotisk
- Anti-inflammatoriske midler
- Antirheumatiske midler
- Antipyretika
- Analgetika, Opioid
- Narkotika
- Respiratoriske midler
- Hostestillende midler
- Acetaminophen
- Oxycodon
- Metadon
- Acetaminophen, hydrocodon-lægemiddelkombination
Andre undersøgelses-id-numre
- Pro00022567
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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