Actively Recruiting

Phase 4
Age: 18Years +
All Genders
Healthy Volunteers
NCT06774274

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

Led by Universidad de Antioquia · Updated on 2025-04-11

120

Participants Needed

1

Research Sites

119 weeks

Total Duration

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Sponsors

U

Universidad de Antioquia

Lead Sponsor

H

Hospital San Vicente Fundación

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients over 18 years of age
  • Elective major orthopedic surgery
  • ASA classification 1, 2, or 3
Not Eligible

You will not qualify if you...

  • Diagnosis of perioperative kidney injury or hepatic failure
  • Active cardiac conditions
  • Cognitive impairment preventing PCA pump use or postoperative interview
  • Scheduled ICU admission with invasive ventilatory support
  • Known hypersensitivity to opioid medications
  • History of severe adverse reactions to opioids or ketamine
  • Pregnancy
  • Use of continuous regional anesthetic techniques (peripheral nerve or epidural catheters)
  • Refusal to participate in the study

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Trial Site Locations

Total: 1 location

1

St. Vincent's Foundation University Hospital

Medellín, Antioquia, Colombia, 050010

Actively Recruiting

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Research Team

F

Fabian D Casas, Professor

CONTACT

M

Mateo Aristizabal, Resident

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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