Post-op Ketamine Study

March 5, 2019 updated by: Rothman Institute Orthopaedics

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Rothman Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

N/A

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Isotonic saline
Placebo
ACTIVE_COMPARATOR: Ketamine
Drug: Ketamine Injectable Solution
Active comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain as reported on Visual Analog Scale
Time Frame: Up to 6 weeks post-operatively
VAS pain reported 0-100mm
Up to 6 weeks post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rothman Institute Orthopaedics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 28, 2016

Primary Completion (ACTUAL)

April 27, 2018

Study Completion (ANTICIPATED)

April 27, 2019

Study Registration Dates

First Submitted

March 5, 2019

First Submitted That Met QC Criteria

March 5, 2019

First Posted (ACTUAL)

March 7, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 7, 2019

Last Update Submitted That Met QC Criteria

March 5, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016Levicoff

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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