Analgesic Efficacy of Intravenous Ketamine as a Continuous Infusion vs PCA in the Management of Acute Postoperative Pain in Major 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
Universidad de Antioquia
120 participants
Mar 1, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- Patients over 18 years of age
- Elective major orthopedic surgery.
- ASA (American Association of Anesthesiology) classification 1, 2 or 3.
Exclusion Criteria9
- 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
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Interventions
A 10% ketamine solution will be prepared in a 250 cc bag of 0.9% saline (1 mg/cc) using 5 cc from a vial of ketamine that has a concentration of 50 mg/cc. The infusion will be initiated at the time of surgical site closure and will proceed as follows: a bolus of 0.35 cc/kg (equivalent to 0.35 mg/kg) will be administered, followed by a continuous infusion of 0.1 cc/kg/h (equivalent to 0.1 mg/kg/h) for up to 48 hours postoperatively. Patients in this group will have access to a PCA pump with morphine for analgesic rescue and to monitor daily opioid consumption.
A mixture of 5% ketamine and 5% morphine will be prepared in a 100 cc bag of 0.9% saline. This will be achieved by using 1 cc of a ketamine vial (50 mg/cc) and 5 cc of a morphine ampule (10 mg/cc). This results in a final concentration of 0.5 mg of ketamine and 0.5 mg of morphine per cc in the 100 cc saline bag. The pump settings will be configured as follows: * PCA (Patient-Controlled Analgesia) dose: 2 cc (which delivers 1 mg of ketamine and 1 mg of morphine) * Lockout interval: 6 minutes * Maximum dose limit: 15 doses over a 4-hour period The pump will be available for patient use for up to 48 hours postoperatively.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06774274