Clinical Trial

Analgesic Efficacy of Intravenous Ketamine as a Continuous Infusion vs PCA in the Management of Acute Postoperative Pain in Major Orthopedic Surgery.

Recruiting Phase 4
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Record status
This record was last updated April 11, 2025 (before its estimated March 30, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-01-13.
Status change: Not Yet Recruiting → Recruiting 2025-04-08
Trial Details
NCT Number NCT06774274
Lead Sponsor Universidad de Antioquia
Collaborators: Hospital San Vicente Fundación
Conditions Pain, Postoperative, Opioid Use, Major Surgery
Enrollment 120 participants
Start Date 2025-03-01
Primary Completion 2026-03-30 (estimated)
Study Completion 2027-06-15 (estimated)
Updated on ClinicalTrials.gov 2025-04-11