Comparison of Postoperative Pain Score Between Perioperative Intravenous Ketamine and Placebo in Patients Undergoing Unilateral Total Knee Arthroplasty Under General Anesthesia

Ministry of Health, Thailand

Status and phase: Enrolling; Phase 4

Conditions: Knee Osteoarthritis

Treatments: Drug: Ketamine group; Drug: Placebo group

Study type: Interventional

Funder types: Other

Identifiers

NCT06267638

Chomthong hospital, Thailand

Details and patient eligibility

About

The goal of this clinical trial is to compare postoperative pain score between perioperative intravenous ketamine and placebo in patients undergoing unilateral total knee arthroplasty under general anesthesia. The main question[s] it aims to answer are:

• Can perioperative intravenous ketamine reduce postoperative pain score during rest and movement at 0, 2, 4, 8, 12, 18, 24 hours better than no administration of Ketamine in patients undergoing Unilateral total knee arthroplasty under general anesthesia?
• Can perioperative intravenous ketamine reduce morphine consumption in postoperative 24 hours, length of hospital stay, first time to receive opioid and side effect or complication from ketamine and opioid better than no administration of Ketamine in patients undergoing Unilateral total knee arthroplasty under general anesthesia? Participants will receive intravenous ketamine intraoperative TKA and comparison group will receive placebo that is normal saline. Researchers will compare perioperative intravenous ketamine and placebo to see postoperative pain score, morphine consumption in postoperative 24 hours, length of hospital stay, first time to receive opioid and side effect or complication from ketamine and opioid.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. A patient undergo unilateral total knee arthroplasty under General anesthesia at Chomthong Hospital Chiang Mai During 2024 to December 2025
2. Age is more than 18 years old
3. ASA (American society of anesthesiologist) status are I,I,III
4. A patient can cooperate in research

Exclusion criteria

• Patients allergic to local anesthetic agent
• Patient who has contraindication to use ketamine
• Patients has coagulopathy.
• Injection site is infected.
• Patients with chronic pain received painkillers for more than 3 months.
• The patient has a history of opioid use.
• The patient has a history of alcohol dependence.
• Patients allergic to fentanyl or morphine.
• Patient who has unstable cardiovascular disease
• Patient who has increase intracranial pressure and high ocular pressure
• Pregnancy
• The patient who has communication problems cannot describe the level of pain
• The patient refused to participate in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

ketamine group

Experimental group

Description:

Participant will receive intraoperative ketamine during total knee arthroplasty by Ketamine 0.5mg /kg loading then 0.25 mg/kg/hours until end of surgery

Treatment:

Drug: Ketamine group

Placebo group

Placebo Comparator group

Description:

Participant will receive intraoperative normal saline during total knee arthroplasty

Treatment:

Drug: Placebo group