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Post-op Ketamine Study

Primary Purpose

Osteo Arthritis Knee

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Isotonic saline
Ketamine Injectable Solution
Sponsored by
Rothman Institute Orthopaedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee

Eligibility Criteria

undefined - undefined (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

Sites / Locations

  • Rothman Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Ketamine

Arm Description

Outcomes

Primary Outcome Measures

Pain as reported on Visual Analog Scale
VAS pain reported 0-100mm

Secondary Outcome Measures

Full Information

First Posted
March 5, 2019
Last Updated
March 5, 2019
Sponsor
Rothman Institute Orthopaedics
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1. Study Identification

Unique Protocol Identification Number
NCT03865550
Brief Title
Post-op Ketamine Study
Official Title
Evaluation of Post Operative Pain Following Primary Total Knee Arthroplasty (TKA) With Intraoperative Subanesthetic Ketamine Administration and Spinal Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 28, 2016 (Actual)
Primary Completion Date
April 27, 2018 (Actual)
Study Completion Date
April 27, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Ketamine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Isotonic saline
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Ketamine Injectable Solution
Intervention Description
Active comparator
Primary Outcome Measure Information:
Title
Pain as reported on Visual Analog Scale
Description
VAS pain reported 0-100mm
Time Frame
Up to 6 weeks post-operatively

10. Eligibility

Eligibility Criteria
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
Facility Information:
Facility Name
Rothman Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

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Post-op Ketamine Study

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