Analgesic Efficacy of Intravenous Ketamine as a Continuous Infusion vs PCA in the Management of Acute Postoperative Pain in Major Orthopedic Surgery.
NCT ID: NCT06774274
Last Updated: 2025-04-11
Study Results
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Basic Information
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RECRUITING
PHASE4
120 participants
INTERVENTIONAL
2025-03-01
2027-06-15
Brief Summary
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* 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.
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Detailed Description
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Current pain management strategies emphasize multimodal analgesia, which involves using multiple medications with different mechanisms of action to minimize side effects. Ketamine has been investigated in this context and has been found effective for treating postoperative pain following major surgeries while reducing the need for opioids. However, there is still some uncertainty regarding the optimal method for administering ketamine after surgery. The aim of this trial is to compare the effectiveness of intravenous ketamine in terms of pain control, measured by numerical pain scores, and opioid consumption within the first 24 hours postoperatively using two different strategies: continuous infusion versus patient-controlled analgesia (PCA) in adults undergoing non-cardiac surgery.
For this research, two hypotheses are proposed, as the objective involves two types of outcomes related to the analgesic effectiveness of intravenous ketamine: pain measured by a numerical pain scale and opioid consumption equivalent to oral morphine.
Based on data from previous studies, it is highly likely that continuous ketamine infusion will provide similar pain control efficacy at 24 hours compared to PCA ketamine. However, the data suggests that continuous infusion may result in lower opioid consumption than PCA. Therefore, the hypotheses are as follows:
\*\*First Hypothesis\*\* Continuous ketamine infusion is not inferior to PCA ketamine for pain control, as measured by a numerical pain scale at 24 hours postoperatively in patients undergoing major orthopedic surgery with a high risk of severe acute pain.
\*\*Second Hypothesis\*\* Continuous ketamine infusion is superior to PCA ketamine in reducing opioid consumption at 24 hours postoperatively in patients undergoing major orthopedic surgery at high risk of severe acute pain.
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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
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.
Study Groups
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Ketamine infusion
Intravenous ketamine administered as a continuous infusion.
Ketamine infusion
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.
PCA Ketamine
Intravenous ketamine administered along with opioid in a single saline bag using a Patient Controlled Analgesia pump
PCA Ketamine
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.
Interventions
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Ketamine infusion
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.
PCA Ketamine
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Elective major orthopedic surgery.
* ASA (American Association of Anesthesiology) classification 1, 2 or 3.
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Hospital San Vicente Fundación
OTHER
Universidad de Antioquia
OTHER
Responsible Party
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Principal Investigators
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Fabian D Casas, Professor
Role: STUDY_CHAIR
Universidad de Antioquia
Locations
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St. Vincent's Foundation University Hospital
Medellín, Antioquia, Colombia
Countries
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Central Contacts
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References
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Other Identifiers
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36-2024
Identifier Type: -
Identifier Source: org_study_id
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