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

M

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

  • 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

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

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

Trial contacts and locations

1

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Central trial contact

Kanokwan Uthaiwan

Data sourced from clinicaltrials.gov

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