Comparing ketamine delivery methods for postoperative pain management in orthopedic surgery
Analgesic Efficacy of Intravenous Ketamine as a Continuous Infusion vs PCA in the Management of Acute Postoperative Pain in Major Orthopedic Surgery: A Randomized Clinical Trial
This study is testing whether giving ketamine through an IV or a patient-controlled pump works better for managing pain after major orthopedic surgery in adults.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universidad de Antioquia Academic / other |
| Locations | 1 site (Medellín, Antioquia) |
| Trial ID | NCT06774274 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of intravenous ketamine administered as a continuous infusion versus a patient-controlled analgesia (PCA) pump for managing postoperative pain in adults undergoing major orthopedic surgery. Participants will be randomly assigned to receive either method, and their pain levels and opioid consumption will be monitored over the first 24 hours post-surgery. The study seeks to determine which method provides better pain control and reduces the need for opioids, addressing a critical aspect of postoperative care.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old scheduled for elective major orthopedic surgery.
Not a fit: Patients with active cardiac conditions, cognitive impairments, or those requiring continuous regional anesthetic techniques may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies that minimize opioid use after major orthopedic surgeries.
How similar studies have performed: Previous studies have shown promising results for ketamine in postoperative pain management, suggesting that this approach may be effective, though the specific comparison of delivery methods is less commonly tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients over 18 years of age * Elective major orthopedic surgery. * ASA (American Association of Anesthesiology) classification 1, 2 or 3. Exclusion Criteria: * Patients with a diagnosis of perioperative kidney injury or hepatic failure * Patients with active cardiac conditions * Patients with any cognitive impairment that disables the patient from operating the PCA pump or impedes the postoperative interview * Patients with scheduled ICU admission with invasive ventilatory support * Patients with known hypersensitivity to opioid medications * Patients with past medical history of severe adverse reactions to opioids or ketamine. * Pregnant patients * Patients undergoing continuous regional anesthetic techniques including peripheral nerve catheters or continuous epidural catheters * Patient refusal to participate in the study
Where this trial is running
Medellín, Antioquia
- St. Vincent's Foundation University Hospital — Medellín, Antioquia, Colombia (Recruiting)
Study contacts
- Study coordinator: Fabian D Casas, Professor
- Email: fabian.casas@udea.edu.co
- Phone: +57 (604) 300574882
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.