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Post-op Ketamine Study

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ClinicalTrials.gov Identifier: NCT03865550
Recruitment Status : Active, not recruiting
First Posted : March 7, 2019
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Tracking Information
First Submitted Date  ICMJE March 5, 2019
First Posted Date  ICMJE March 7, 2019
Last Update Posted Date March 7, 2019
Actual Study Start Date  ICMJE March 28, 2016
Actual Primary Completion Date April 27, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2019)
Pain as reported on Visual Analog Scale [ Time Frame: Up to 6 weeks post-operatively ]
VAS pain reported 0-100mm
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Post-op Ketamine Study
Official Title  ICMJE Evaluation of Post Operative Pain Following Primary Total Knee Arthroplasty (TKA) With Intraoperative Subanesthetic Ketamine Administration and Spinal Anesthesia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteo Arthritis Knee
Intervention  ICMJE
  • Drug: Isotonic saline
    Placebo
  • Drug: Ketamine Injectable Solution
    Active comparator
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Isotonic saline
  • Active Comparator: Ketamine
    Intervention: Drug: Ketamine Injectable Solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: March 5, 2019)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 27, 2019
Actual Primary Completion Date April 27, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE Not Provided
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03865550
Other Study ID Numbers  ICMJE 2016Levicoff
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rothman Institute Orthopaedics
Study Sponsor  ICMJE Rothman Institute Orthopaedics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rothman Institute Orthopaedics
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP