Knee OsteoarthritisPhase 4NCT06267638
Comparison of Postoperative Pain Score Between Perioperative Intravenous Ketamine and Placebo in Patients Undergoing Unilateral Total Knee Arthroplasty Under General Anesthesia
A Phase 4 study testing Ketamine group in people with Knee Osteoarthritis, run by Ministry of Health, Thailand at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Ketamine group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- 22 Jan 2024to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Chomthong hospital
Chiang Mai, 50160
Numphung Sukantarat, master, 66855426519, phuang_007@yahoo.com
About this study
Official title: 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Ketamine group, Placebo group
- Keywords
- ketamine, total knee arthroplasty, general anesthesia, Total Knee Arthropathy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine groupDrug
Participants will receive intraoperative ketamine during total knee arthroplasty
Placebo groupDrug
Participants will receive intraoperative normal saline during total knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Ketamine group |
| Placebo group | Placebo comparator | Participant will receive intraoperative normal saline during total knee arthroplasty Receives: Drug: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain score at rest and movement
pain score at rest and movement by numeric rating scale 0-10
Measured: 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 after operation was finished
Measured: First time to receive intravenous analgesic drug ( From finished anesthetic time until First time to receive intravenous analgesic drug(minute)
Morphine consumption
Post operative morphine consumption or morphine equivalent (milligram)
Measured: post operative time at 0 ,2 ,4 ,8 ,12 ,18 ,24 hours
Length of hospital stay
Length of hospital stay : When participant admit to discharge
Measured: Time that patient was admited to hospital until patient was discharge from hospital.
side effect and complication from ketamine and opioid
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
- =minimal nausea and vomiting don't need medication
- = 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
- minimal sedation : response to verbal conversation
- moderated sedation : sleeping but easy to response to verbal conversation
- deep sedation : difficult to response to
Measured: post operative time within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start22 Jan 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Thailand
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Numphung Sukantarat, Ministry of Health, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267638
- Sponsor's protocol ID
- Chomthong hospital, Thailand
- Status last verified
- Mar 2024
- First submitted
- 2 Feb 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06267638
- Acronym / sponsor ID
- Chomthong hospital, Thailand
- Conditions
- Knee Osteoarthritis
- Keywords
- ketamine, total knee arthroplasty, general anesthesia, Total Knee Arthropathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ministry of Health, ThailandOther government
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ketamine group | Experimental | Drug: Ketamine groupParticipant 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 comparator | Drug: Placebo groupParticipant will receive intraoperative normal saline during total knee arthroplasty |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine groupParticipants will receive intraoperative ketamine during total knee arthroplasty | Drug | ketamine group |
| Placebo groupParticipants will receive intraoperative normal saline during total knee arthroplasty | Drug | Placebo group |
Primary outcome
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
4 secondary outcomes
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)
Morphine consumption
Time frame: 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.
side effect and complication from ketamine and opioid
Time frame: post operative time within 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine group in people with Knee Osteoarthritis, run by Ministry of Health, Thailand at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kanokwan Uthaiwan (66836999444, manarw1@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain score at rest and movement (time frame: post operative time at 0 ,2 ,4 ,8 ,12 ,18 ,24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.