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

NCT06774274 | Recruiting Phase 4 DMC

• 1 other identifier: 36-2024
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain, Postoperative; Opioid Use; Major Surgery

Keywords

postoperative pain; ketamine; patient controlled analgesia; continuous infusion; major surgery; pain; abdominal surgery; thoracic surgery; spine surgery; opioid; major orthopedic surgery

Outcome Measures

Primary Outcomes (2)

• Postoperative pain

  Visual Analog Scale (VAS) for dynamic (during movement) pain. The VAS for pain is a unidimensional measure of pain intensity in adults.The pain VAS is a continuous visual scale from 0 to 100 mm, with 0 mm representing "no pain" and 100 mm representing maximum pain (e.g. "worst pain imaginable").

  24 hours after surgery

• Postoperative opioid use

  Daily opioid use expressed in morphine equivalents (morphine equivalent daily dose MEDD)

  24 hours after surgery

Secondary Outcomes (14)

• Dynamic and rest postoperative pain

  12, 24, 48, and 72 hours after surgery

• Postoperative opioid use

  48 and 72 hours after surgery

• Time to ambulation

  72 hours after surgery

• Hospital stay

  From date of randomization until the date day of discharge or date of death from any cause, whichever came first, assessed up to 36 months

• Postoperative nausea and vomiting

  24 hours after surgery

Study Arms (2)

Ketamine infusion

ACTIVE COMPARATOR

Intravenous ketamine administered as a continuous infusion.

Drug: Ketamine infusion

PCA Ketamine

ACTIVE COMPARATOR

Intravenous ketamine administered along with opioid in a single saline bag using a Patient Controlled Analgesia pump

Drug: PCA Ketamine

Interventions

Ketamine infusion DRUG

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.

Ketamine infusion

PCA Ketamine DRUG

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.

Also known as: Ketamine PCA

PCA Ketamine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years of age
• Elective major orthopedic surgery.
• ASA (American Association of Anesthesiology) classification 1, 2 or 3.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Antioquia: lead
• Hospital San Vicente Fundación: collaborator

Study Sites (1)

St. Vincent's Foundation University Hospital

Medellín, Antioquia, 050010, Colombia

RECRUITING

Related Publications (29)

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MeSH Terms

Conditions

Pain, Postoperative; Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Fabian D Casas, Professor

  Universidad de Antioquia

  STUDY CHAIR

Central Study Contacts

Fabian D Casas, Professor

CONTACT

+57 (604) 300574882; fabian.casas@udea.edu.co

Mateo Aristizabal, Resident

CONTACT

+57 3104285832; mateo.aristizabalh@udea.edu.co

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Treating Anesthesiologist: The anesthesiologist responsible for the case and intraoperative management will be blinded to the assigned intervention. The assignment will be carried out by another anesthesiologist who is not involved in the case. This external anesthesiologist will be present in the operating room, and after opening the envelope, will inform the nursing staff regarding which drug mixtures to prepare. Data Collection and Analysis Staff: Data will be collected during the hospital stay, up to three days, by two researchers. The researchers will be blinded to the assignment and will not have access to information about the prepared drug mixtures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This trial will be a triple-blind, parallel-group, pragmatic, non-inferiority controlled clinical trial focused on pain management and superiority regarding opioid use, along with other secondary outcomes.

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 14, 2025
• Study Start: March 1, 2025
• Primary Completion: March 30, 2026
• Study Completion (Estimated): June 15, 2027
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)