Post-op Ketamine Study

NCT ID: NCT03865550

Last Updated: 2019-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-28

Study Completion Date

2019-04-27

Brief Summary

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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

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Conditions

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Osteo Arthritis Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Isotonic saline

Intervention Type DRUG

Placebo

Ketamine

Group Type ACTIVE_COMPARATOR

Ketamine Injectable Solution

Intervention Type DRUG

Active comparator

Interventions

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Isotonic saline

Placebo

Intervention Type DRUG

Ketamine Injectable Solution

Active comparator

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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Rothman Institute Orthopaedics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rothman Institute

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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2016Levicoff

Identifier Type: -

Identifier Source: org_study_id

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