Clinical Effectiveness of Pre-operative Methadone in Single Level Lateral Transpsoas Interbody Fusions
Status:
Not yet recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
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.
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.
Phase:
Phase 1
Details
Lead Sponsor:
The Methodist Hospital Research Institute The Methodist Hospital System
Treatments:
Acetaminophen Acetaminophen, hydrocodone drug combination Methadone Oxycodone