Randomized Controlled Study of Ketamine Administration for Postoperative Pain Management in Patients Undergoing Knee Arthroplasty,
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Russian Federation
Pirogov National Medical and Surgical Center
RECRUITING
Moscow
Contact Information
Primary
Ivan Shcheparev, MD, PhD
is22@list.ru
+7 901 908 90 88
Backup
Boris Teplykh, MD
batru@mail.ru
+7 916 616-60-38
Time Frame
Start Date:2025-07-01
Estimated Completion Date:2026-01-31
Participants
Target number of participants:100
Treatments
Experimental: Ketamine Plus Standard Analgesia
Participants in this group will receive standardized postoperative pain management (ketoprofen 100 mg twice daily and paracetamol 1000 mg every 8 hours for 24 hours after knee arthroplasty) plus a continuous intravenous infusion of ketamine using PCA at 0.15 mg/kg/h, with 1 mg boluses available every 5 minutes (maximum daily dose 500 mg), for 24 hours after knee arthroplasty. Morphine 10 mg intramuscularly (IM) may be administered as needed for rescue therapy.
Active_comparator: Standard Analgesia Alone
Participants in this group will receive standardized postoperative pain management (ketoprofen 100 mg twice daily and paracetamol 1000 mg every 8 hours for 24 hours after knee arthroplasty) without ketamine infusion. Morphine 10 mg IM may be administered as needed for rescue therapy.