About this trial
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
Qualifiers
Patients over 18 years of age
Elective major orthopedic surgery.
ASA (American Association of Anesthesiology) classification 1, 2 or 3.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Ketamine infusion
- PCA Ketamine
Treatment groups
Sponsors and collaborators
Universidad de Antioquia
Lead sponsor
Hospital San Vicente Fundación
Collaborator