Brief Summary

Total knee replacement is associated with severe post-operative pain. The purpose of this study is to compare two methods of treatment for pain control following Total Knee Replacement with an accelerated physical therapy protocol to aid the achievement of rehab milestones.

Trial Health

On Track

Trial Health Score

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

Enrollment

111

participants targeted

Target at P50-P75 for phase_4

Timeline

Completed

Started Nov 2014

Geographic Reach

1 country

1 active site

Status

completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

1.8 years study duration

Study Start

First participant enrolled

November 1, 2014

Completed

9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2014

Completed

7 days until next milestone

First Posted

Study publicly available on registry

November 17, 2014

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed

2.4 years until next milestone

Results Posted

Study results publicly available

January 11, 2019

Completed

Last Updated

January 11, 2019

Status Verified

January 1, 2019

Enrollment Period

1.8 years

First QC Date

November 10, 2014

Results QC Date

August 1, 2018

Last Update Submit

January 10, 2019

Conditions

Osteoarthritis

Keywords

Nerve BlockRehabilitationKnee Replacement, Total

Outcome Measures

Primary Outcomes (1)

Time to Meet Physical Therapy Discharge Criteria
Time to reach physical therapy (PT) goals
First 3 days post-operatively

Secondary Outcomes (10)

Numerical Rating Scale (NRS) Pain Scores With Ambulation Postoperative Day 1
24 hours after operating room discharge
NRS Pain Score With Movement POD2
48 hours after surgery
Opioid Consumption Postoperative Day (POD) 1
0-24 hours postoperatively
Opioid Consumption POD2
24-48 hours postoperative
Hospital Length of Stay
Average of 3 days
+5 more secondary outcomes

Study Arms (2)

Peri-Articular Injections only

ACTIVE COMPARATOR

Intra-Operatively * Spinal anesthetic with 0.5% bupivacaine (10 or 12.5) * Surgeon will perform the periarticular injections: * First deep injection prior to cementation Bupivacaine 0.5% with epinephrine, 30cc Morphine, 8 mg/ml, 1 cc Methylprednisolone, 40 mg/ml, 1 ml Cefazolin, 500 mg in 10 ml Normal saline, 22cc * Second superficial injection prior to closure. 1.20 ml 0.25% bupivacaine * Intravenous sedation with midazolam and propofol.

Drug: BupivacaineDrug: MorphineDrug: MethylprednisoloneDrug: CefazolinDrug: Normal salineDrug: MidazolamDrug: PropofolDrug: Dexamethasone

Peri-Articular Injections and Adductor Canal Block

EXPERIMENTAL

Intra-Operatively * Spinal anesthetic with 0.5% bupivacaine (10 or 12.5) * Adductor canal block technique: * Supine position, after IV sedation * Ultrasound guided with linear transducer 8 MHz. Chiba needle, 22 G / 4 inches * Femoral artery will be identified in the adductor canal deep to the Sartorius muscle * 15 cc of Bupivacaine 0.25% with 2 mg of Preservative free Dexamethasone * Local anesthetic will be delivered periarterial between 12 and 6 o'clock * Intravenous sedation with midazolam and propofol. * First deep injection prior to cementation Bupivacaine 0.5% with epinephrine, 30cc Morphine, 8 mg/ml, 1 cc Methylprednisolone, 40 mg/ml, 1 ml Cefazolin, 500 mg in 10 ml Normal saline, 22cc * Second superficial injection prior to closure. 20 ml 0.25% bupivacaine

Drug: BupivacaineDrug: MorphineDrug: MethylprednisoloneDrug: CefazolinDrug: Normal salineDrug: MidazolamDrug: PropofolDrug: DexamethasoneDevice: 8 MHz. Chiba needle, 22 G / 4 inches