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Post-op Ketamine Study

Evaluation of Post Operative Pain Following Primary Total Knee Arthroplasty (TKA) With Intraoperative Subanesthetic Ketamine Administration and Spinal Anesthesia

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03865550
Enrollment
75
Registered
2019-03-07
Start date
2016-03-28
Completion date
2019-04-27
Last updated
2019-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteo Arthritis Knee

Brief 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. 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.

Interventions

DRUGIsotonic saline

Placebo

Active comparator

Sponsors

Rothman Institute Orthopaedics
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

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

Design outcomes

Primary

MeasureTime frameDescription
Pain as reported on Visual Analog ScaleUp to 6 weeks post-operativelyVAS pain reported 0-100mm

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026