Post-op Ketamine Study
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ClinicalTrials.gov Identifier: NCT03865550 |
Recruitment Status : Unknown
Verified March 2019 by Rothman Institute Orthopaedics.
Recruitment status was: Active, not recruiting
First Posted : March 7, 2019
Last Update Posted : March 7, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteo Arthritis Knee | Drug: Isotonic saline Drug: Ketamine Injectable Solution | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 75 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Evaluation of Post Operative Pain Following Primary Total Knee Arthroplasty (TKA) With Intraoperative Subanesthetic Ketamine Administration and Spinal Anesthesia |
Actual Study Start Date : | March 28, 2016 |
Actual Primary Completion Date : | April 27, 2018 |
Estimated Study Completion Date : | April 27, 2019 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo |
Drug: Isotonic saline
Placebo |
Active Comparator: Ketamine |
Drug: Ketamine Injectable Solution
Active comparator |
- Pain as reported on Visual Analog Scale [ Time Frame: Up to 6 weeks post-operatively ]VAS pain reported 0-100mm

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Ages Eligible for Study: | Child, Adult, Older Adult |
Inclusion Criteria:
- 18 - 85 years of age
- ASA I - IV
- Undergoing primary unilateral elective total knee arthroplasty with spinal anesthesia
Exclusion Criteria:
- 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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03865550
United States, Pennsylvania | |
Rothman Institute | |
Philadelphia, Pennsylvania, United States, 19107 |
Responsible Party: | Rothman Institute Orthopaedics |
ClinicalTrials.gov Identifier: | NCT03865550 |
Other Study ID Numbers: |
2016Levicoff |
First Posted: | March 7, 2019 Key Record Dates |
Last Update Posted: | March 7, 2019 |
Last Verified: | March 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Osteoarthritis Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Ketamine Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Anesthetics, Dissociative Anesthetics, Intravenous Anesthetics, General Anesthetics Central Nervous System Depressants Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |