Osteo Arthritis KneeNCT03865550
Post-op Ketamine Study
A study testing Isotonic saline and Ketamine Injectable Solution in people with Osteo Arthritis Knee, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
The purpose of this study is to establish the effect of sub-anesthetic dosing of ketamine with spinal anesthesia during total knee arthroplasty on post-operative pain and narcotic consumption. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Isotonic saline and Ketamine Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2016to 27 Apr 2019
- Phase
- Interventional
- 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 Any age
- Child, Adult, Older adult
Who may be able to join
- 18 - 85 years of age
- ASA I - IV
- Undergoing primary unilateral elective total knee arthroplasty with spinal anesthesia
Who cannot join
- BMI over 40*
- Contraindication or allergy to opioid pain medication or ketamine*
- Daily opioid use for pain control before surgery in excess of systemic morphine equivalent to 10 mg*
- Ejection fraction (EF) less than 30%
- Creatinine clearance less than 30 mL/min*
- History of chronic liver failure
Show all 10Show fewer
- Desire for nerve block or general anesthesia
- Any neurologic or psychiatric disorder (including bipolar disorder, post traumatic stress disorder, schizophrenia)
- Prior surgery on ipsilateral knee within the last 6 months
- Alcohol abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Post Operative Pain Following Primary Total Knee Arthroplasty (TKA) With Intraoperative Subanesthetic Ketamine Administration and Spinal Anesthesia
The purpose of this study is to establish the effect of sub-anesthetic dosing of ketamine with spinal anesthesia during total knee arthroplasty on post-operative pain and narcotic consumption. We hypothesize that sub-anesthetic ketamine will decrease post-operative pain and narcotic consumption and may secondarily lead to shorter lengths of stay, faster rehabilitation, improved postoperative outcomes and patient satisfaction.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Isotonic saline, Ketamine Injectable Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isotonic salineDrug
Placebo
Ketamine Injectable SolutionDrug
Active comparator
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Isotonic saline |
| Ketamine | Active comparator | Not described Receives: Drug: Ketamine Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain as reported on Visual Analog Scale
VAS pain reported 0-100mm
Measured: Up to 6 weeks post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start28 Mar 2016
- Primary completion27 Apr 2018
- Study completion27 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865550
- Sponsor's protocol ID
- 2016Levicoff
- Status last verified
- Mar 2019
- First submitted
- 5 Mar 2019
- Last updated
- 7 Mar 2019
- 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 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post Operative Pain Following Primary Total Knee Arthroplasty (TKA) With Intraoperative Subanesthetic Ketamine Administration and Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT03865550
- Acronym / sponsor ID
- 2016Levicoff
- Conditions
- Osteo Arthritis Knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 28 Mar 2016 (actual)
- Primary completion
- 27 Apr 2018 (actual)
- Study completion
- 27 Apr 2019 (estimated)
- First posted
- 7 Mar 2019 (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 purpose of this study is to establish the effect of sub-anesthetic dosing of ketamine with spinal anesthesia during total knee arthroplasty on post-operative pain and narcotic consumption. We hypothesize that sub-anesthetic ketamine will decrease post-operative pain and narcotic consumption and may secondarily lead to shorter lengths of stay, faster rehabilitation, improved postoperative outcomes and patient satisfaction.
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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: Isotonic saline |
| Ketamine | Active comparator | Drug: Ketamine Injectable Solution |
Who may qualify
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 18 - 85 years of age
- ASA I - IV
- Undergoing primary unilateral elective total knee arthroplasty with spinal anesthesia
Key exclusion criteria (10 listed)
- BMI over 40*
- Contraindication or allergy to opioid pain medication or ketamine*
- Daily opioid use for pain control before surgery in excess of systemic morphine equivalent to 10 mg*
- Ejection fraction (EF) less than 30%
- Creatinine clearance less than 30 mL/min*
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 |
|---|---|---|
| Isotonic salinePlacebo | Drug | Placebo |
| Ketamine Injectable SolutionActive comparator | Drug | Ketamine |
Primary outcome
Pain as reported on Visual Analog Scale
Time frame: Up to 6 weeks post-operatively
VAS pain reported 0-100mm
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isotonic saline and Ketamine Injectable Solution in people with Osteo Arthritis Knee, run by Rothman Institute Orthopaedics at 1 site in United States.
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 3 inclusion and 10 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 7 Mar 2019. 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 United States. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain as reported on Visual Analog Scale (time frame: Up to 6 weeks post-operatively). 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 7 Mar 2019; AzTrials last refreshed its copy on 27 Oct 2026.