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Clinical Trials/NCT06267638
NCT06267638RecruitingPhase 4

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

Ministry of Health, Thailand1 site in 1 country100 target enrollmentStarted: January 22, 2024Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Recruiting
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Postoperative pain score at rest and movement
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

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

Intervention: Ketamine group (Drug)

Placebo group

Placebo Comparator

Participant will receive intraoperative normal saline during total knee arthroplasty

Intervention: Placebo group (Drug)

Outcomes

Primary Outcomes

Postoperative pain score at rest and movement

Time Frame: 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 Outcomes

  • 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)

Investigators

Sponsor
Ministry of Health, Thailand
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Numphung Sukantarat

Anesthsiologist of Chomthong hospital, Chiangmai

Ministry of Health, Thailand

Study Sites (1)

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