Status:
UNKNOWN
Clinical Effectiveness of Pre-operative Methadone in Single Level Lateral Transpsoas Interbody Fusions
Lead Sponsor:
The Methodist Hospital Research Institute
Conditions:
Degenerative Disc Disease
Spondylolisthesis, Lumbar Region
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief 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 comorbid...
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 obe...
Eligibility Criteria
Inclusion
- Age: 18 - 70
- Will undergo one level minimally invasive lumbar fusion surgery
- Primary symptoms are back and/or leg pain
Exclusion
- 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
Key Trial Info
Start Date :
February 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04112550
Start Date
February 11 2020
End Date
December 31 2021
Last Update
January 29 2020
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