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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Patients over 18 years of age

• Elective major orthopedic surgery.

• ASA (American Association of Anesthesiology) classification 1, 2 or 3.

Locations
Other Locations
Colombia
St. Vincent's Foundation University Hospital
RECRUITING
Medellín
Contact Information
Primary
Fabian D Casas, Professor
fabian.casas@udea.edu.co
+57 (604) 300574882
Backup
Mateo Aristizabal, Resident
mateo.aristizabalh@udea.edu.co
+57 3104285832
Time Frame
Start Date: 2025-03-01
Estimated Completion Date: 2027-06-15
Participants
Target number of participants: 120
Treatments
Active_comparator: Ketamine infusion
Intravenous ketamine administered as a continuous infusion.
Active_comparator: PCA Ketamine
Intravenous ketamine administered along with opioid in a single saline bag using a Patient Controlled Analgesia pump
Related Therapeutic Areas
Sponsors
Collaborators: Hospital San Vicente Fundación
Leads: Universidad de Antioquia

This content was sourced from clinicaltrials.gov