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

PHASE4RecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

March 1, 2025

Primary Completion Date

March 30, 2026

Study Completion Date

June 15, 2027

Conditions
Pain, PostoperativeOpioid UseMajor Surgery
Interventions
DRUG

Ketamine infusion

"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."

DRUG

PCA Ketamine

"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."

Trial Locations (1)

050010

RECRUITING

St. Vincent's Foundation University Hospital, Medellín

All Listed Sponsors
collaborator

Hospital San Vicente Fundación

OTHER

lead

Universidad de Antioquia

OTHER