NCT03865550

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 7, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2019

Completed
Last Updated

March 7, 2019

Status Verified

March 1, 2019

Enrollment Period

2.1 years

First QC Date

March 5, 2019

Last Update Submit

March 5, 2019

Conditions

Osteo Arthritis Knee

Outcome Measures

Primary Outcomes (1)

  • Pain as reported on Visual Analog Scale

    VAS pain reported 0-100mm

    Up to 6 weeks post-operatively

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Isotonic saline

Ketamine

ACTIVE COMPARATOR
Drug: Ketamine Injectable Solution

Interventions

Isotonic salineDRUG

Placebo

Placebo
Ketamine Injectable SolutionDRUG

Active comparator

Ketamine

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • ASA I - IV
  • Undergoing primary unilateral elective total knee arthroplasty with spinal anesthesia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2019

First Posted

March 7, 2019

Study Start

March 28, 2016

Primary Completion

April 27, 2018

Study Completion

April 27, 2019

Last Updated

March 7, 2019

Record last verified: 2019-03

Locations

US(1)