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Pain, PostoperativePhase 4NCT06774274

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

A Phase 4 study testing Ketamine infusion and PCA Ketamine in people with Pain, Postoperative and Opioid Use, run by Universidad de Antioquia at 1 site in Colombia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Pain, Postoperative, Opioid Use, Major Surgery
What is being tested?
Ketamine infusion and PCA Ketamine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteColombia
Study dates
1 Mar 2025to 15 Jun 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.
Show all 9Show fewer
  • Pregnant patients
  • Patients undergoing continuous regional anesthetic techniques including peripheral nerve catheters or continuous epidural catheters
  • Patient refusal to participate in the study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Fabian D Casas, Professor contact

+57 (604) 300574882

fabian.casas@udea.edu.co

Mateo Aristizabal, Resident contact

+57 3104285832

mateo.aristizabalh@udea.edu.co

Colombia1 site, 1 recruiting

  • St. Vincent's Foundation University Hospital

    Medellín, Antioquia, 050010

    Recruiting

Other trials in Colombia

About this study

Official title: 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

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?
Read more

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.

Read the detailed description

Managing postoperative pain is a primary concern for patients undergoing major surgery, especially in major orthopedic surgery. Effective pain management is crucial, as uncontrolled postoperative pain can lead to prolonged hospital stays, decreased patient satisfaction, and various complications, including pulmonary and gastrointestinal issues.

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.

Being tested
Ketamine infusion, PCA Ketamine
Keywords
postoperative pain, ketamine, patient controlled analgesia, continuous infusion, major surgery, pain, abdominal surgery, thoracic surgery, spine surgery, opioid, major orthopedic surgery
Medical subject headings
Pain, Postoperative, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ketamine infusionDrug

    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 KetamineDrug

    Also called Ketamine PCA

    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.

Study groups in NCT06774274
Study groupRoleWhat they receive
Ketamine infusionActive comparatorIntravenous ketamine administered as a continuous infusion.
Receives: Drug: Ketamine infusion
PCA KetamineActive comparatorIntravenous ketamine administered along with opioid in a single saline bag using a Patient Controlled Analgesia pump
Receives: Drug: PCA Ketamine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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").

    Measured: 24 hours after surgery

  2. Postoperative opioid use

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

    Measured: 24 hours after surgery

Secondary outcomes (14)

  1. Dynamic and rest postoperative pain

    Visual Analog Scale (VAS) for dynamic and rest postoperative 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")

    Measured: 12, 24, 48, and 72 hours after surgery

  2. Postoperative opioid use

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

    Measured: 48 and 72 hours after surgery

  3. Time to ambulation

    Time measured in days for the patient to begin ambulation after surgery.

    Measured: 72 hours after surgery

  4. Hospital stay

    Days of hospital stay

    Measured: 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

  5. Postoperative nausea and vomiting

    Proportion of patients with at least one episode of nausea or vomiting after surgery

    Measured: 24 hours after surgery

  6. Respiratory depression

    Proportion of patients with any episode of respiratory rate <8 breaths per minute accompanied by supplemental oxygen requirement higher than a simple nasal cannula; or the requirement of facial mask ventilation or tracheal intubation; or requirement of naloxone reversal

    Measured: 72 hours after surgery

  7. Oversedation

    Proportion of patients with any episode of sedation measured as a level 4 or higher using Ramsay's sedation scale

    Measured: 2, 12, 24, 48, and 72 hours after surgery

  8. Psychomimetic symptoms

    Proportion of patients with at least one of the following symptoms:

    • Hallucinations: Defined as any tactile, visual, auditory, or sensory experience in the absence of an appropriate stimulus, referred by the patient as real
    • Nightmares: Defined as any vivid dream with a negative or dysphoric emotional content

    Measured: 72 hours after surgery

  9. Delirium

    Proportion of patients diagnosed with delirium using the Confusion Assessment Method scale

    Measured: 72 hours after surgery

  10. Hemodynamic measurements - Arterial pressure

    Systolic, diastolic, and mean arterial pressure in mmHg.

    Measured: 2, 12, 24, 48, and 72 hours after surgery

  11. Hemodynamic measurements - Heart rate

    Heart rate in beats per minute.

    Measured: 2, 12, 24, 48, and 72 hours after surgery

  12. Urinary retention

    Proportion of patients with any event of impossibility for spontaneous micturition reported by the patient requiring physical measures or urinary catheter insertion for resolution

    Measured: 72 hours after surgery

  13. Pruritus

    Proportion of patients reporting any episode of itching in any body region

    Measured: 72 hours after surgery

  14. Time to first bowel movement

    Measured in time to initiation of the first passing of stool or flatus

    Measured: 72 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2025
  2. Study start1 Mar 2025
  3. Primary completion30 Mar 2026 (estimated)
  4. Study completion15 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06774274
Sponsor's protocol ID
36-2024
Status last verified
Apr 2025
First submitted
7 Jan 2025
Last updated
11 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: It was not approved by our Institutional Research Board.

Publications

  • Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, Altman DG, Barbour V, Macdonald H, Johnston M, Lamb SE, Dixon-Woods M, McCulloch P, Wyatt JC, Chan AW, Michie S. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014 Mar 7;348:g1687. doi: 10.1136/bmj.g1687.

    PubMed 24609605

  • Jouguelet-Lacoste J, La Colla L, Schilling D, Chelly JE. The use of intravenous infusion or single dose of low-dose ketamine for postoperative analgesia: a review of the current literature. Pain Med. 2015 Feb;16(2):383-403. doi: 10.1111/pme.12619. Epub 2014 Dec 19.

    PubMed 25530168

  • Laskowski K, Stirling A, McKay WP, Lim HJ. A systematic review of intravenous ketamine for postoperative analgesia. Can J Anaesth. 2011 Oct;58(10):911-23. doi: 10.1007/s12630-011-9560-0. Epub 2011 Jul 20.

    PubMed 21773855

  • Waelkens P, Alsabbagh E, Sauter A, Joshi GP, Beloeil H; PROSPECT Working group * * of the European Society of Regional Anaesthesia and Pain therapy (ESRA). Pain management after complex spine surgery: A systematic review and procedure-specific postoperative pain management recommendations. Eur J Anaesthesiol. 2021 Sep 1;38(9):985-994. doi: 10.1097/EJA.0000000000001448.

    PubMed 34397527

  • Schwenk ES, Viscusi ER, Buvanendran A, Hurley RW, Wasan AD, Narouze S, Bhatia A, Davis FN, Hooten WM, Cohen SP. 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. Reg Anesth Pain Med. 2018 Jul;43(5):456-466. doi: 10.1097/AAP.0000000000000806.

    PubMed 29870457

  • Vadeghani AT, Grant M, Forget P. Perioperative pain management interventions in opioid user patients: an overview of reviews. BMC Anesthesiol. 2024 Sep 5;24(1):310. doi: 10.1186/s12871-024-02703-6.

    PubMed 39237892

  • Meyer-Friessem CH, Lipke E, Weibel S, Kranke P, Reichl S, Pogatzki-Zahn EM, Zahn PK, Schnabel A. Perioperative ketamine for postoperative pain management in patients with preoperative opioid intake: A systematic review and meta-analysis. J Clin Anesth. 2022 Jun;78:110652. doi: 10.1016/j.jclinane.2022.110652. Epub 2022 Jan 19.

    PubMed 35065394

  • Xu L, Xu S, Zhang Y, Huang Y. Effects of anesthetic adjunctive agents on postoperative cognitive dysfunction in elderly patients undergoing noncardiac surgery: A Bayesian network meta-analysis. Brain Behav. 2023 Aug;13(8):e3149. doi: 10.1002/brb3.3149. Epub 2023 Jul 11.

    PubMed 37431799

  • Sun W, Zhou Y, Wang J, Fu Y, Fan J, Cui Y, Wu Y, Wang L, Yu Y, Han R. Effects of Ketamine on Chronic Postsurgical Pain in Patients Undergoing Surgery: A Systematic Review and Meta-analysis. Pain Physician. 2023 May;26(3):E111-E122.

    PubMed 37192226

  • Aguirre-Cadavid LF, Ramírez-Luján CD, Casas-Arroyave FD, Calle-Cadavid E, Camelo-Rincón JE, Cadavid-Puentes AM. Psychomimetic Effects of Low-Dose Ketamine Infusions in Postoperative Pain: A Cohort Study.

  • Cadavid AM, Casas FD, Camelo JE, Tovar A, Ramirez CD, Calle E, Visbal K. Effect of Analgesic Low-Dose Ketamine Infusions on the Cardiovascular Response: A Retrospective Analysis. Pain Physician. 2023 Sep;26(5):495-502.

    PubMed 37774188

  • Cadavid-Puentes AM, Camelo Rincón JE, Casas Arroyave FD, Chávez Lasso EF, Leyton Ortega M, Tovar Gutiérrez A. Hemodynamic response to sub-anesthetic doses of ketamine for postoperative pain: systematic review. Colomb J Anesthesiol. Available since february 12, 2024 52(2).

  • Zhou JY, Hamilton P, Macres S, Pena M, Tang S. Update on Ketamine. Adv Anesth. 2020 Dec;38:97-113. doi: 10.1016/j.aan.2020.07.005. Epub 2020 Sep 14. No abstract available.

    PubMed 34106842

  • Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.

    PubMed 23392233

  • Hannon CP, Fillingham YA, Gililland JM, Sporer SM, Casambre FD, Verity TJ, Woznica A, Nelson N, Hamilton WG, Della Valle CJ. A Systematic Review of the Efficacy and Safety of Ketamine in Total Joint Arthroplasty. J Arthroplasty. 2023 Apr;38(4):763-768.e2. doi: 10.1016/j.arth.2022.10.037. Epub 2022 Oct 31.

    PubMed 36328104

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ketamine infusion and PCA Ketamine in people with Pain, Postoperative and Opioid Use, run by Universidad de Antioquia at 1 site in Colombia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Fabian D Casas, Professor (+57 (604) 300574882, fabian.casas@udea.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative pain (time frame: 24 hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06774274, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.

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