TERMINATED

Dosing of Methadone for Spine Surgery

Conditions

Pain, Postoperative Post-operative pain Spine surgery Methadone Opioid

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study compares two methods of dosing methadone for complex spine cases

Official Title

Dosing of Methadone for Spine Surgery

Quick Facts

Study Start:2019-03-19

Study Completion:2025-05-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT03605901

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Patients must consent to participate and sign the IRB-approved informed consent prior to beginning any study specific procedures. 2. At or between the ages 18 to 75 years. 3. Undergoing multilevel thoracic, thoracolumbar and/or lumbar spine surgery with instrumentation and fusion.	1. Methadone or buprenorphine use. 2. Morbid obesity with BMI\>40 Kg/m2. 3. Chronic renal failure with creatinine\>2.0 mg/dL. 4. Liver failure as determined by cirrhosis or history of fulminant hepatic failure. 5. Current or historical alcohol abuse. 6. Current or historical drug abuse. 7. Patients with history of prolonged QTc, as defined as a QTc value \>450 ms in males and \>460 ms in females. 8. Patients with ASA status IV or V. 9. Surgical diagnosis including spine tumor, infection, or trauma. 10. In the Principal Investigator's opinion is not a candidate for the study. 11. Unwilling to sign the informed consent form.

Inclusion Criteria

Exclusion Criteria

1. Patients must consent to participate and sign the IRB-approved informed consent prior to beginning any study specific procedures.
2. At or between the ages 18 to 75 years.
3. Undergoing multilevel thoracic, thoracolumbar and/or lumbar spine surgery with instrumentation and fusion.

1. Methadone or buprenorphine use.
2. Morbid obesity with BMI\>40 Kg/m2.
3. Chronic renal failure with creatinine\>2.0 mg/dL.
4. Liver failure as determined by cirrhosis or history of fulminant hepatic failure.
5. Current or historical alcohol abuse.
6. Current or historical drug abuse.
7. Patients with history of prolonged QTc, as defined as a QTc value \>450 ms in males and \>460 ms in females.
8. Patients with ASA status IV or V.
9. Surgical diagnosis including spine tumor, infection, or trauma.
10. In the Principal Investigator's opinion is not a candidate for the study.
11. Unwilling to sign the informed consent form.

Contacts and Locations

Principal Investigator

Christoph Seubert, MD

PRINCIPAL_INVESTIGATOR

University of Florida

Study Locations (Sites)

UF Health

Gainesville, Florida, 32610-3003

United States

Collaborators and Investigators

Sponsor: University of Florida

Christoph Seubert, MD, PRINCIPAL_INVESTIGATOR, University of Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-03-19

Study Completion Date2025-05-09

Study Record Updates

Study Start Date2019-03-19

Study Completion Date2025-05-09

Terms related to this study

Keywords Provided by Researchers

Post-operative pain
Spine surgery
Methadone
Opioid

Additional Relevant MeSH Terms

Pain, Postoperative