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RecruitingPhase 4

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

NCT06774274 · Universidad de Antioquia

Recruiting
Status
Accepting participants
Phase 4
Phase
120
Target enrolment
1
Study sites
Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Postoperative pain

    Measured over 24 hours after surgery

  • Postoperative opioid use

    Measured over 24 hours after surgery

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion Criteria: * Patients over 18 years of age * Elective major orthopedic surgery. * ASA (American Association of Anesthesiology) classification 1, 2 or 3. Exclusion Criteria: * 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

1 study site

FacilityCityRegionCountry
St. Vincent's Foundation University HospitalMedellínAntioquiaColombia

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT06774274 on ClinicalTrials.gov →

Last updated in the registry 2025-04-11. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits