Post-op Ketamine Study

Osteo Arthritis Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03865550
• Other study ID #: 2016Levicoff
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 28, 2016
• Est. completion date: April 27, 2019

Study information

• Verified date: March 2019
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: April 27, 2019
• Est. primary completion date: April 27, 2018
• Gender: All
• Age group: N/A and older

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

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Isotonic saline
Placebo
• Ketamine Injectable Solution
Active comparator

Locations

Country	Name	City	State
United States	Rothman Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain as reported on Visual Analog Scale	VAS pain reported 0-100mm	Up to 6 weeks post-operatively