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

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06267638
• Other study ID #: Chomthong hospital, Thailand
• Status: Recruiting
• Phase: Phase 4
• Start date: January 22, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Ministry of Health, Thailand
• Contact: Kanokwan Uthaiwan
• Phone: 66836999444
• Email: manarw1[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Pain, Postoperative

Intervention

Drug:
• Ketamine group
Participants will receive intraoperative ketamine during total knee arthroplasty
• Placebo group
Participants will receive intraoperative normal saline during total knee arthroplasty

Locations

Country	Name	City	State
Thailand	Chomthong hospital	Chiangmai

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Health, Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain score at rest and movement	pain score at rest and movement by numeric rating scale 0-10	post operative time at 0 ,2 ,4 ,8 ,12 ,18 ,24 hours
Secondary	First time to receive intravenous analgesic drug	First time to receive intravenous analgesic drug after operation was finished	First time to receive intravenous analgesic drug ( From finished anesthetic time until First time to receive intravenous analgesic drug(minute)
Secondary	Morphine consumption	Post operative morphine consumption or morphine equivalent (milligram)	post operative time at 0 ,2 ,4 ,8 ,12 ,18 ,24 hours
Secondary	Length of hospital stay	Length of hospital stay : When participant admit to discharge	Time that patient was admited to hospital until patient was discharge from hospital.
Secondary	side effect and complication from ketamine and opioid	Number of Participants with side effect form Ketamine and opioid: Hallucination, Nightmare, Arrythmia , Nausea vomiting respiratory distress ,Pruritus within 24 hours after operation. Do you have hallucination or nightmare? : yes no; Nausea vomiting : - Severity of nausea 4 scale : 0 = No; =minimal nausea and vomiting don't need medication; = nausea and vomiting participant was improved when received medication 3= nausea and vomiting participant wasn't improved when received medication Pruritus score 0= no; 1= minimal 2= severe and need medication respiratory distress : sedation scale 0 = awake; minimal sedation : response to verbal conversation; moderated sedation : sleeping but easy to response to verbal conversation; deep sedation : difficult to response to	post operative time within 24 hours