Clinical Effectiveness of Pre-operative Methadone in Single Level Lateral Transpsoas Interbody Fusions

NCT04112550 | Unknown Phase 1 FDA Drug

• 1 other identifier: Pro00022567
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Degenerative Disc Disease; Spondylolisthesis, Lumbar Region

Keywords

lateral lumbar interbody fusion; minimally invasive spinal surgery

Outcome Measures

Primary Outcomes (2)

• Post-operative in-hospital patient's narcotic requirement

  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)

  Change in ODI (scale from 0 to 100) from pre-op to post-op (14 days post-op)

  14 days

Study Arms (2)

Methadone

ACTIVE COMPARATOR

This cohort will receive oral methadone 15mg po tablet pre-operatively

Drug: Methadone Hydrochloride

Oxycodone

ACTIVE COMPARATOR

This cohort will receive oxycodone/acetaminophen 10/325 po tablet pre-operatively

Drug: Oxycodone-Acetaminophen

Interventions

Methadone Hydrochloride DRUG

FDA approved medication to treat pain

Methadone

Oxycodone-Acetaminophen DRUG

FDA approved medication to treat pain

Oxycodone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 - 70
• Will undergo one level minimally invasive lumbar fusion surgery
• Primary symptoms are back and/or leg pain

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spondylolisthesis

Interventions

Methadone; oxycodone-acetaminophen

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals

Study Officials

• Sean M Barber, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saeed S Sadrameli, MD, MS

CONTACT

2817431385; ssadrameli@houstonmethodist.org

Marcus S Wong, MD

CONTACT

8324574452; mswong@houstonmethodist.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurosurgery Faculty

Study Record Dates

• First Submitted: September 27, 2019
• First Posted: October 2, 2019
• Study Start: February 11, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 29, 2020

Record last verified: 2020-01