Pain Control and Quality of Recovery After Intravenous Methadone Versus Intravenous Remifentanil in Craniotomy Surgery

Launched by UNIVERSITY OF VIRGINIA · Jan 30, 2025

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ClinConnect Summary

This clinical trial is studying the effectiveness of intravenous (IV) methadone compared to IV remifentanil for managing pain after craniotomy surgery, which is a type of brain surgery. Both medications are used to help control pain, but the researchers believe that methadone, given as a single dose, may provide better pain relief and improve recovery without the need for multiple doses of other pain medications. The goal is to see if methadone can help patients experience less pain and complications in the first 72 hours after surgery.

To participate in this trial, you would need to be an adult between 18 and 65 years old, undergoing specific types of brain surgery, and in generally good health. You should also be able to read and understand English. If eligible, participants can expect to receive either methadone or remifentanil during their surgery and will be monitored for pain levels and recovery after the procedure. It's important to note that certain health conditions and prior use of specific medications may exclude potential participants from the trial.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Adult Patients between ages 18 and 65 years old.
• • 2. Undergoing supratentorial intracranial surgery
• • 3. American Society of Anesthesiologists (ASA) physiological status I-III
• • 4. Body Mass Index (BMI) between 18.5 and 45
• • 5. Ability to understand and read English
• Exclusion Criteria:
• • 1. Being unable or unwilling to sign a consent
• • 2. Anticipated discharge within 24 hours after surgery
• • 3. Patients requiring Emergent Surgery
• • 4. Preoperative usage of Methadone, or allergy to it.
• • 5. Patients with chronic pain, requiring daily opioid use at the time of surgery, MME \>60 as FDA defines opioid tolerant as 60 MME, long-acting forms of opioids such as fentanyl patch, oxycontin
• • 6. Active or Prior Substance Use Disorder, undergoing active treatment with Medication of Opioid Use Disorder including methadone (once daily dosing), Buprenorphine (any formulation) and Naltrexone
• • 7. Preoperative chronic renal insufficiency or failure (defined as a serum creatinine more than 2 mg/dl),
• • 8. Pregnancy
• • 9. Significant liver disease (cirrhosis or hepatic failure)
• • 10. QTc \>450 on preoperative electrocardiogram
• • 11. Pulmonary disease necessitating home oxygen therapy
• • 12. Inability to speak or read the English language