Clinical trial NCT06267638: Comparison of Postoperative Pain Score Between Perioperative Intravenous Ketamine and Placebo in Patients Undergoing Unilateral Total Knee Arthroplasty Under General Anesthesia
Official title: Comparison of Postoperative Pain Score Between Perioperative Intravenous Ketamine and Placebo in Patients Undergoing Unilateral Total Knee Arthroplasty Under General Anesthesia, A Prospective Randomized Controlled Trial Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Knee Osteoarthritis
Keywords: ketamine
total knee arthroplasty
general anesthesia
Total Knee Arthropathy
Lead sponsor: Ministry of Health, Thailand
Sponsor class: OTHER_GOV
First posted: 2024-02-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative pain score at rest and movement
timeFrame: post operative time at 0 ,2 ,4 ,8 ,12 ,18 ,24 hours
Secondary outcomes:
measure: First time to receive intravenous analgesic drug
timeFrame: First time to receive intravenous analgesic drug ( From finished anesthetic time until First time to receive intravenous analgesic drug(minute)
measure: Morphine consumption
timeFrame: post operative time at 0 ,2 ,4 ,8 ,12 ,18 ,24 hours
measure: Length of hospital stay
timeFrame: Time that patient was admited to hospital until patient was discharge from hospital.
measure: side effect and complication from ketamine and opioid
timeFrame: post operative time within 24 hours
Other outcomes:
Locations:
city: Chiangmai
country: Thailand
facility: Chomthong hospital
Study officials:
References: