N/A
N=100
Ketamine Administration for Postoperative Pain Management in Patients Undergoing Knee Arthroplasty
Knee Arthroplasty · Postoperative Pain · Pain Management · Analgesia · Opioid Use
Bottom Line
View on ClinicalTrials.gov: NCT07059429 ↗Enrolled (actual)
100
Serious AEs
2.0%
Results posted
Mar 2026
Primary outcome: Primary: Total Opioid Consumption in Morphine Equivalents Within 24 Hours After Surgery — 0; 10 mg morphine equivalents (MME)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ketamine (Drug); Standard Analgesia (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
- Primary completion
- Dec 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Opioid Consumption in Morphine Equivalents Within 24 Hours After Surgery |
0; 10 | — |
| SECONDARY Pain Intensity Assessed by Numeric Rating Scale (NRS) |
1.91; 2.83; 1.74; 2.44 | — |
| SECONDARY Incidence of Postoperative Nausea and Vomiting |
11; 4 | — |
| SECONDARY Number of Participants With Neuropsychiatric Adverse Events |
14; 3; 2; 0 | 0.005 sig |
| SECONDARY Severity of Neuropsychiatric Adverse Events |
14; 3; 1; 0; 1; 0 | — |
| SECONDARY Cumulative Ketamine Dose Administered |
304; 0 | — |
Summary
This study is conducted to evaluate the effectiveness and safety of ketamine infusion for pain relief after knee replacement surgery. Adult patients who have undergone knee arthroplasty will be randomly assigned to one of two groups. The study group will receive standard pain management plus a continuous infusion of ketamine using patient-controlled analgesia (PCA), while the control group will only receive standard pain management. All patients will be monitored for pain intensity using the Numeric Rating Scale (NRS) at several time points the first 24 hours after surgery. The study will compare the total amount of opioid pain medication required, the level of pain experienced, and the frequency and severity of side effects such as nausea, vomiting, and neuropsychiatric reactions. The goal is to determine whether adding ketamine to standard pain management reduces opioid use and improves pain control without increasing side effects. The results improve pain management strategies after knee replacement surgery.
Eligibility Criteria
Inclusion Criteria
- Age greater than 18 years and less than 90 years.
- Patients who have undergone knee arthroplasty.
- The patient has read the information sheet and signed the informed consent form.
Exclusion Criteria
- Spinal anesthesia performed intraoperatively.
- Epidural analgesia administered postoperatively.
- Perioperative blockade of the sciatic nerve, genicular nerve, or lumbar plexus.
- Allergy to ketamine or non-steroidal anti-inflammatory drugs.
- Contraindications to ketamine as specified in the product instructions.
- Time from the end of surgery to study enrollment exceeds 24 hours.
- Ineffectiveness of analgesia as provided by the study protocol.
Data sourced from ClinicalTrials.gov (NCT07059429). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.