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

March 9, 2024 updated by: Numphung Sukantarat, Ministry of Health, Thailand

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Thailand
      • Chiangmai, Thailand, 50160
        • Recruiting
        • Chomthong hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: Ketamine group
Participants will receive intraoperative ketamine during total knee arthroplasty
Placebo Comparator: Placebo group
Participant will receive intraoperative normal saline during total knee arthroplasty
Drug: Placebo group
Participants will receive intraoperative normal saline during total knee arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
post operative time at 0 ,2 ,4 ,8 ,12 ,18 ,24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First time to receive intravenous analgesic drug
Time Frame: 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
First time to receive intravenous analgesic drug ( From finished anesthetic time until First time to receive intravenous analgesic drug(minute)
Morphine consumption
Time Frame: post operative time at 0 ,2 ,4 ,8 ,12 ,18 ,24 hours
Post operative morphine consumption or morphine equivalent (milligram)
post operative time at 0 ,2 ,4 ,8 ,12 ,18 ,24 hours
Length of hospital stay
Time Frame: Time that patient was admited to hospital until patient was discharge from hospital.
Length of hospital stay : When participant admit to discharge
Time that patient was admited to hospital until patient was discharge from hospital.
side effect and complication from ketamine and opioid
Time Frame: 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
post operative time within 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ministry of Health, Thailand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

February 2, 2024

First Submitted That Met QC Criteria

February 12, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 9, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Chomthong hospital, Thailand

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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