Ketamine Administration for Postoperative Pain Management in Patients Undergoing Knee Arthroplasty

NCT07059429 | Completed Results

• 1 other identifier: NMSC-01-25
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain Management; Analgesia; Opioid Use; Ketamine; Knee Arthroplasty; Postoperative Pain

Keywords

Ketamine; Knee Replacement; Total Knee Arthroplasty; Postoperative Analgesia; Patient-Controlled Analgesia; PCA; Opioid Sparing; Multimodal Pain Management; Morphine Consumption; Neuropsychiatric Side Effects; Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• Total Opioid Consumption in Morphine Equivalents Within 24 Hours After Surgery

  The total dose of opioid analgesics (calculated in milligrams of morphine equivalents) administered to each patient during the first 24 hours after knee arthroplasty.

  24 hours postoperatively

Secondary Outcomes (5)

• Pain Intensity Assessed by Numeric Rating Scale (NRS)

  2-10 hours and 10-24 hours postoperatively

• Incidence of Postoperative Nausea and Vomiting

  24 hours postoperatively

• Number of Participants With Neuropsychiatric Adverse Events

  0-10 hours and 10-24 hours postoperatively

• Severity of Neuropsychiatric Adverse Events

  24 hours postoperatively

• Cumulative Ketamine Dose Administered

  24 hours postoperatively

Study Arms (2)

Ketamine Plus Standard Analgesia

EXPERIMENTAL

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.

Drug: Ketamine

Standard Analgesia Alone

ACTIVE COMPARATOR

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.

Drug: Standard Analgesia

Interventions

Ketamine DRUG

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.

Ketamine Plus Standard Analgesia

Standard Analgesia DRUG

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.

Standard Analgesia Alone

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia: lead

Study Sites (1)

Pirogov National Medical and Surgical Center

Moscow, 105203, Russia

Location

Related Publications (13)

• 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.

  PMID: 21773855 BACKGROUND

• 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.

  PMID: 15271729 BACKGROUND

• 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.

  PMID: 12933413 BACKGROUND

• 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.

  PMID: 25530168 BACKGROUND

• 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.

  PMID: 22227789 BACKGROUND

• 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.

  PMID: 18627367 BACKGROUND

• 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.

  PMID: 30570761 BACKGROUND

• 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.

  PMID: 26133677 BACKGROUND

• 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.

  PMID: 26003764 BACKGROUND

• 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.

  PMID: 36247824 BACKGROUND

• 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.

  PMID: 34335740 BACKGROUND

• 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.

  PMID: 35897081 BACKGROUND

• 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.

  PMID: 29870457 BACKGROUND

Related Links

• Official website of the Pirogov National Medical and Surgical Center

MeSH Terms

Conditions

Pain, Postoperative; Agnosia; Nausea; Vomiting

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

Single-center study with small sample size (n=100). Short 24-hour follow-up period limits detection of late adverse events. No long-term outcomes assessed.

Results Point of Contact

• Title: Ivan Shcheparev, MD, PhD
• Organization: Pirogov National Medical and Surgical Center

is22@list.ru

+7 (901) 908-90-88

Study Officials

• Boris Teplykh, MD

  Pirogov National Medical and Surgical Center

  STUDY DIRECTOR

• Ivan Shcheparev, MD, PhD

  Pirogov National Medical and Surgical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups: 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.

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 10, 2025
• Study Start: July 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: January 7, 2026
• Last Updated: March 2, 2026
• Results First Posted: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 2 months after completion of the study
• Access Criteria: upon the request

Locations

RU (1)