Dosing of Methadone for Spine Surgery

Launched by UNIVERSITY OF FLORIDA · Jul 26, 2018

Keywords

ClinConnect Summary

This clinical trial is studying different ways to give methadone, a medication often used for pain relief, to patients undergoing complex spine surgeries. The goal is to see which method works best for managing pain after surgery. The trial is currently looking for participants between the ages of 18 and 75 who are scheduled for certain types of spine surgeries that involve multiple levels of the spine.

To be eligible for this study, patients must be able to give their consent and sign a form agreeing to participate. However, there are some important factors that could exclude someone from joining, such as a history of certain substance use, severe obesity, or specific medical conditions affecting the kidneys or liver. Participants will have the opportunity to help researchers understand pain management better and may receive valuable care during their recovery. If you're interested or think you might qualify, discussing this trial with your healthcare provider could be a great next step.

Gender

ALL

Eligibility criteria

• Inclusion 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.
• Exclusion Criteria:
• • 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.