Actively Recruiting

Phase 4
Age: 18Years +
All Genders
Healthy Volunteers
ID06774274

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

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

120

Participants Needed

1

Research Sites

63 weeks

Total Duration

On this page

Sponsors

U

Universidad de Antioquia

Lead Sponsor

H

Hospital San Vicente Fundación

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating how to best manage pain after major orthopedic surgery in adults. This clinical trial compares two ways of giving ketamine, a pain-relieving medicine: a continuous intravenous infusion versus a patient-controlled analgesia (PCA) pump. The study aims to see if continuous infusion is as effective as PCA for pain control and if it reduces the need for opioid pain medicines within the first 24 hours after surgery. Participants will be randomly assigned to one of two groups. One group receives ketamine through a continuous infusion starting at surgical closure, with specific dosing for 48 hours. The other group uses a PCA pump delivering a mix of ketamine and morphine, allowing patients to control their doses with limits set by the pump for up to 48 hours. Both groups have access to rescue morphine via PCA if needed. The trial is designed to be triple-blind, ensuring unbiased results. During the first three days after surgery, researchers will visit participants in the hospital to assess pain levels and monitor side effects. Various outcomes will be measured, including pain at rest and with movement, opioid use, time to walking, length of hospital stay, nausea, sedation, delirium, and vital signs. Participants may be followed for up to 36 months to assess long-term outcomes such as hospital stay duration and recovery. The total treatment and observation period is focused on the initial 72 hours after surgery.

CONDITIONS

Brief 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
  • Pregnant patients
  • Use of continuous regional anesthetic techniques including peripheral nerve or epidural catheters
  • Refusal to participate in the study

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 48 hours postoperatively

Participants receive intravenous ketamine by either continuous infusion or patient-controlled analgesia (PCA) for pain management after major orthopedic surgery.

Continuous monitoring during hospital stay for up to 48 hours

Follow-up

Duration - Up to 72 hours after surgery

Participants are monitored for pain control, opioid use, and potential side effects up to 72 hours after surgery.

Assessments at 12, 24, 48, and 72 hours after surgery

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

M

Mateo Aristizabal, Resident

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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Published Research Related To This Trial

Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide.

Tammy C Hoffmann, Paul P Glasziou, Isabelle Boutron...

https://pubmed.ncbi.nlm.nih.gov/24609605

The use of intravenous infusion or single dose of low-dose ketamine for postoperative analgesia: a review of the current literature.

Julie Jouguelet-Lacoste, Luca La Colla, Dennis Schilling...

https://pubmed.ncbi.nlm.nih.gov/25530168

Pain management after complex spine surgery: A systematic review and procedure-specific postoperative pain management recommendations.

Piet Waelkens, Emissia Alsabbagh, Axel Sauter...

https://pubmed.ncbi.nlm.nih.gov/34397527

Consensus Guidelines on the Use of Intravenous Ketamine Infusions for Acute Pain Management From the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, and the American Society of Anesthesiologists.

Eric S Schwenk, Eugene R Viscusi, Asokumar Buvanendran...

https://pubmed.ncbi.nlm.nih.gov/29870457

Perioperative ketamine for postoperative pain management in patients with preoperative opioid intake: A systematic review and meta-analysis.

Christine H Meyer-Frießem, Erik Lipke, Stephanie Weibel...

https://pubmed.ncbi.nlm.nih.gov/35065394

Effects of anesthetic adjunctive agents on postoperative cognitive dysfunction in elderly patients undergoing noncardiac surgery: A Bayesian network meta-analysis.

Lichi Xu, Shuxiang Xu, Yuelun Zhang...

https://pubmed.ncbi.nlm.nih.gov/37431799