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

Recruiting now · Phase 4

Conditions studied: Pain, Postoperative, Opioid Use, Major Surgery

In brief

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.

Key facts

Study ID: NCT06774274
Run by: Universidad de Antioquia
People needed: 120
Starts: 2025-03-01
Expected to finish: 2027-06-15
Last updated by the study team: 2025-04-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Patients over 18 years of age
Elective major orthopedic surgery.
ASA (American Association of Anesthesiology) classification 1, 2 or 3.

You may not qualify if…

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 it is running

St. Vincent's Foundation University Hospital — Medellín, Antioquia, Colombia (enrolling)

Full record on ClinicalTrials.gov

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