Ketamine Administration for Postoperative Pain Management in Patients Undergoing Knee Arthroplasty
NCT ID: NCT07059429
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2025-07-01
2026-01-31
Brief Summary
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Detailed Description
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Participants will be randomly assigned to either the study group or the control group. Both groups will receive standardized pain management with ketoprofen and paracetamol in keeping with current guidelines. The study group will receive an additional continuous infusion of ketamine using PCA at a rate of 0.15 mg/kg/h, with 1 mg boluses available in 5-minute lockout intervals and a maximum daily dose of 500 mg. In both groups, opioid analgesics (morphine 10 mg intramuscularly as needed) will be administered if pain control is inadequate. Regional nerve blocks may be repeated under ultrasound guidance if necessary; patients requiring repeated femoral nerve block will be analyzed separately.
Pain intensity will be assessed using the NRS at 0, 2, 4, 6, 10, 14, 18, and 24 hours postoperatively. Data will be collected on the total dose of opioids used, additional analgesic requirements, the number and severity of neuropsychiatric adverse events (graded according to CTCAE), the frequency of postoperative nausea and vomiting, and the total dose and number of ketamine boluses administered.
The primary outcome is the total dose of opioid analgesics (morphine equivalents, mg) administered the first 24 hours after surgery. Secondary outcomes include pain scores at each time point, incidence and severity of neuropsychiatric side effects, frequency of postoperative nausea and vomiting, and total ketamine dose received.
The study is designed to compare the efficacy and safety of ketamine infusion in reducing opioid consumption and improving pain control after knee arthroplasty, while closely monitoring adverse events. The results aim to provide evidence for optimizing multimodal analgesia in orthopedic surgery.This clinical trial was preceded by a pilot study involving patients undergoing knee arthroplasty. The pilot phase aimed to evaluate the variability of key parameters such as pain intensity, opioid requirements, and the incidence of neuropsychiatric side effects. Based on the analysis of the investigators' published data, modifications were made in the main study protocol, including adjustments to the ketamine bolus dose within the PCA regimen to optimize efficacy and safety.
The changes were introduced to enhance pain control and minimize adverse effects in the main study population. The current trial involves these protocol refinements, and the investigators anticipate that the optimized ketamine dosing schedule will lead to improved outcomes compared to the initial regimen.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
the intervention group (standardized postoperative analgesia plus ketamine infusion via patient-controlled analgesia),
or the control group (standardized postoperative analgesia without ketamine). Randomization will be performed using permuted blocks of six patients. There will be no crossover or switching between groups; all interventions and assessments will be conducted independently and concurrently for both groups.
The study is single-center and prospective.
TREATMENT
NONE
Study Groups
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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.
Ketamine
Ketamine administered intravenously at 0.15 mg/kg/h via PCA with 1 mg boluses, 5-minute lockout, maximum 500 mg per 24 hours after knee arthroplasty.
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.
Standard Analgesia
Standard analgesia includes ketoprofen 100 mg twice daily and paracetamol 1000 mg every 8 hours for 24 hours after knee arthroplasty; morphine 10 mg IM as needed for rescue therapy.
Interventions
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Ketamine
Ketamine administered intravenously at 0.15 mg/kg/h via PCA with 1 mg boluses, 5-minute lockout, maximum 500 mg per 24 hours after knee arthroplasty.
Standard Analgesia
Standard analgesia includes ketoprofen 100 mg twice daily and paracetamol 1000 mg every 8 hours for 24 hours after knee arthroplasty; morphine 10 mg IM as needed for rescue therapy.
Eligibility Criteria
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Inclusion Criteria
* Patients who have undergone knee arthroplasty.
* The patient has read the information sheet and signed the informed consent form.
Exclusion Criteria
* 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.
18 Years
90 Years
ALL
No
Sponsors
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State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
OTHER
Responsible Party
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Principal Investigators
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Boris Teplykh, MD
Role: STUDY_DIRECTOR
Pirogov National Medical and Surgical Center
Ivan Shcheparev, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Pirogov National Medical and Surgical Center
Locations
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Pirogov National Medical and Surgical Center
Moscow, , Russia
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Subramaniam K, Subramaniam B, Steinbrook RA. Ketamine as adjuvant analgesic to opioids: a quantitative and qualitative systematic review. Anesth Analg. 2004 Aug;99(2):482-95, table of contents. doi: 10.1213/01.ANE.0000118109.12855.07.
Guillou N, Tanguy M, Seguin P, Branger B, Campion JP, Malledant Y. The effects of small-dose ketamine on morphine consumption in surgical intensive care unit patients after major abdominal surgery. Anesth Analg. 2003 Sep;97(3):843-847. doi: 10.1213/01.ANE.0000075837.67275.36.
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.
American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.
Fischer HB, Simanski CJ, Sharp C, Bonnet F, Camu F, Neugebauer EA, Rawal N, Joshi GP, Schug SA, Kehlet H; PROSPECT Working Group. A procedure-specific systematic review and consensus recommendations for postoperative analgesia following total knee arthroplasty. Anaesthesia. 2008 Oct;63(10):1105-23. doi: 10.1111/j.1365-2044.2008.05565.x. Epub 2008 Jul 10.
Brinck EC, Tiippana E, Heesen M, Bell RF, Straube S, Moore RA, Kontinen V. Perioperative intravenous ketamine for acute postoperative pain in adults. Cochrane Database Syst Rev. 2018 Dec 20;12(12):CD012033. doi: 10.1002/14651858.CD012033.pub4.
Bell RF, Dahl JB, Moore RA, Kalso EA. WITHDRAWN: Perioperative ketamine for acute postoperative pain. Cochrane Database Syst Rev. 2015 Jul 2;2015(7):CD004603. doi: 10.1002/14651858.CD004603.pub3.
Porter SB, McClain RL, Howe BL, Ardon AE, Mazer LS, Knestrick BM, Clendenen AM. Perioperative ketamine for acute postoperative analgesia: the Mayo Clinic-Florida experience. J Perianesth Nurs. 2015 Jun;30(3):189-95. doi: 10.1016/j.jopan.2015.01.010.
Pouldar TM, Maher DP, Betz AW, Wiegers JJ, Friedman JA, Zaidi SS, Rejali A, Tran HP, Yumul R, Louy C. Adverse Effects Associated with Patient-Controlled Analgesia with Ketamine Combined with Opioids and Ketamine Infusion with PCA Bolus in Postoperative Spine Patients: A Retrospective Review. J Pain Res. 2022 Oct 10;15:3127-3135. doi: 10.2147/JPR.S358770. eCollection 2022.
Seman MT, Malan SH, Buras MR, Butterfield RJ, Harold KL, Madura JA, Rosenfeld DM, Gorlin AW. Low-Dose Ketamine Infusion for Perioperative Pain Management in Patients Undergoing Laparoscopic Gastric Bypass: A Prospective Randomized Controlled Trial. Anesthesiol Res Pract. 2021 Jul 21;2021:5520517. doi: 10.1155/2021/5520517. eCollection 2021.
Puzio TJ, Klugh J, Wandling MW, Green C, Balogh J, Prater SJ, Stephens CT, Sergot PB, Wade CE, Kao LS, Harvin JA. Ketamine for acute pain after trauma: the KAPT randomized controlled trial. Trials. 2022 Jul 27;23(1):599. doi: 10.1186/s13063-022-06511-6.
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.
Related Links
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Official website of the Pirogov National Medical and Surgical Center
Other Identifiers
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NMSC-01-25
Identifier Type: -
Identifier Source: org_study_id
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