NCT06774274 Analgesic Efficacy of Intravenous Ketamine as a Continuous Infusion vs PCA in the Management of Acute Postoperative Pain in Major Orthopedic Surgery.
| NCT ID | NCT06774274 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Universidad de Antioquia |
| Condition | Pain, Postoperative |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2026-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 120 participants in total. It began in 2025-03-01 with a primary completion date of 2026-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to determine whether treating pain after surgery with ketamine is more effective when administered intravenously as a continuous infusion or through a patient-controlled analgesia (PCA) pump. This study focuses on adult volunteers following major orthopedic surgery. We have two main questions to address: * Is a continuous intravenous infusion of ketamine as effective as ketamine administered through a PCA pump for managing pain after major orthopedic surgery. * Does a continuous intravenous infusion of ketamine result in lower opioid requirements compared to ketamine delivered through a PCA pump for pain management after major orthopedic surgery? Participants will be divided into two groups. One group will receive ketamine via continuous infusion, while the other will receive it through a PCA pump. Both groups will also receive a placebo (a substance that looks like the drug but contains no active ingredients), ensuring that neither group knows whether they are receiving ketamine through the PCA pump (which always contains a painkiller) or as a continuous infusion. Participants will be assigned to one of the two groups and will receive their assigned treatment for 48 hours while hospitalized. Researchers will visit participants during their first three days in the hospital to assess their pain levels and monitor for any side effects.
Eligibility 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
Contact & Investigator
Fabian D Casas, Professor
STUDY CHAIR
Universidad de Antioquia
Frequently Asked Questions
Who can join the NCT06774274 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pain, Postoperative. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06774274 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06774274 currently recruiting?
Yes, NCT06774274 is actively recruiting participants. Contact the research team at fabian.casas@udea.edu.co for enrollment information.
Where is the NCT06774274 trial being conducted?
This trial is being conducted at Medellín, Colombia.
Who is sponsoring the NCT06774274 clinical trial?
NCT06774274 is sponsored by Universidad de Antioquia. The principal investigator is Fabian D Casas, Professor at Universidad de Antioquia. The trial plans to enroll 120 participants.