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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The Methodist Hospital Research Institute; The Methodist Hospital System
• Treatments: Acetaminophen; Acetaminophen, hydrocodone drug combination; Methadone; Oxycodone

Criteria

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