Understanding how kidney function affects methadone use for pain management after surgery
Postoperative Pharmacokinetics of Methadone in Patients With Chronic Kidney Disease
This study is testing how chronic kidney disease affects the way methadone works for pain relief after surgery in patients using an IV pump.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pontificia Universidad Catolica de Chile Academic / other |
| Locations | 1 site (Santiago) |
| Trial ID | NCT06056245 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate how chronic kidney disease influences the pharmacokinetics of methadone administered through an intravenous patient-controlled analgesia (IV-PCA) pump for managing acute postoperative pain. Participants will be recruited prior to surgery and will receive methadone while their blood samples are collected to measure drug levels. The study will be conducted at the Pontifical Catholic University of Chile Hospital, with careful monitoring and data management throughout the process. The primary focus is to determine if methadone's effectiveness is impaired in patients with reduced kidney function.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with chronic kidney disease who are scheduled for surgery requiring general anesthesia and IV-PCA.
Not a fit: Patients with severe liver disease, those requiring dialysis, or individuals with chronic opioid use may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients with chronic kidney disease undergoing surgery.
How similar studies have performed: While similar studies on methadone pharmacokinetics exist, this specific focus on chronic kidney disease is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with chronic kidney disease (CrCl 15-60 ml/min) * Patients over 18 years old undergoing surgery requiring general anesthesia with subsequent use of intravenous methadone patient-controlled analgesia * Hospital stay ≥ 48 hours * Body mass index 18-35 kg/m2 Exclusion Criteria: * History of liver disease * Need for dialysis (hemo or peritoneal dialysis) * Use of home oxygen therapy * American Society of Anesthesiologists (ASA) physical status IV-V * Pregnancy * Chronic opioid use * Methadone allergy * Prolonged QT interval * Use of antiarrhythmics that prolong the QT interval * Inability to understand the proper use of PCA
Where this trial is running
Santiago
- Pontificia Universidad Católica de Chile — Santiago, Chile (Recruiting)
Study contacts
- Study coordinator: Eduardo Vega, MD
- Email: eavega@uc.cl
- Phone: 223543270
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.