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

Phase 4

Recruiting

• Conditions: Knee Osteoarthritis
• Interventions: Drug: Ketamine group; Drug: Placebo group

• Registration Number: NCT06267638
• Lead Sponsor: Ministry of Health, Thailand

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-22
• Study First Submitted: 2024-02-02
• Study First Submitted QC: 2024-02-12
• Study First Posted: 2024-02-20
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-09
• Last Update Posted: 2024-03-12
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ketamine group	Ketamine group	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
Placebo group	Placebo group	Participant will receive intraoperative normal saline during total knee arthroplasty

Primary Outcome Measures

Name	Time	Method
Postoperative pain score at rest and movement	post operative time at 0 ,2 ,4 ,8 ,12 ,18 ,24 hours	pain score at rest and movement by numeric rating scale 0-10

Secondary Outcome Measures

Name	Time	Method
First time to receive intravenous analgesic drug	First time to receive intravenous analgesic drug ( From finished anesthetic time until First time to receive intravenous analgesic drug(minute)	First time to receive intravenous analgesic drug after operation was finished
Morphine consumption	post operative time at 0 ,2 ,4 ,8 ,12 ,18 ,24 hours	Post operative morphine consumption or morphine equivalent (milligram)
Length of hospital stay	Time that patient was admited to hospital until patient was discharge from hospital.	Length of hospital stay : When participant admit to discharge
side effect and complication from ketamine and opioid	post operative time within 24 hours	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; 1. =minimal nausea and vomiting don't need medication; 2. = 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; 1. minimal sedation : response to verbal conversation; 2. moderated sedation : sleeping but easy to response to verbal conversation; 3. deep sedation : difficult to response to

Trial Locations

Locations (1)

Chomthong hospital; 🇹🇭 Chiangmai, Thailand