Post-op Ketamine Study

Rothman Institute Orthopaedics

Status: Unknown

Conditions: Osteo Arthritis Knee

Treatments: Drug: Ketamine Injectable Solution; Drug: Isotonic saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03865550

2016Levicoff

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Isotonic saline

Ketamine

Active Comparator group

Treatment:

Drug: Ketamine Injectable Solution