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

NCT06267638 | Recruiting Phase 4

• 1 other identifier: Chomthong hospital, Thailand
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

ketamine; total knee arthroplasty; general anesthesia; Total Knee Arthropathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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)

• Morphine consumption

  post operative time at 0 ,2 ,4 ,8 ,12 ,18 ,24 hours

• Length of hospital stay

  Time that patient was admited to hospital until patient was discharge from hospital.

• side effect and complication from ketamine and opioid

  post operative time within 24 hours

Study Arms (2)

ketamine group

EXPERIMENTAL

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

Drug: Ketamine group

Placebo group

PLACEBO COMPARATOR

Participant will receive intraoperative normal saline during total knee arthroplasty

Drug: Placebo group

Interventions

Ketamine group DRUG

Participants will receive intraoperative ketamine during total knee arthroplasty

ketamine group

Placebo group DRUG

Participants will receive intraoperative normal saline during total knee arthroplasty

Placebo group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ministry of Health, Thailand: lead

Study Sites (1)

Chomthong hospital

Chiang Mai, 50160, Thailand

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Kanokwan Uthaiwan

CONTACT

66836999444; manarw1@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthsiologist of Chomthong hospital, Chiangmai

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 20, 2024
• Study Start: January 22, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

TH (1)