NCT02253784

Brief Summary

The addition of dexamethasone (DxaM) to local anesthetic may significantly prolong the duration of a block in total knee arthroplasty. The aim of this study is to determine whether this is a systemic or local effect.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2017

Completed
Last Updated

October 31, 2017

Status Verified

October 1, 2014

Enrollment Period

2 years

First QC Date

September 29, 2014

Last Update Submit

October 30, 2017

Conditions

AnalgesiaPain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Efficacy Perineural DxaM

    Duration of motor and sensory block

    One day

Secondary Outcomes (1)

  • Efficacy of Systemic DxaM

    One day

Study Arms (3)

Group I (ISB-P)

ACTIVE COMPARATOR

Four nerve blocks with perineural injection of dexamethasone 0.1 mg/kg and bupivacaine 0.5% - 45 ml

Drug: DexamethasoneDrug: Bupivacaine

Group II (ISB-S)

ACTIVE COMPARATOR

Four nerve blocks with systemic injection of dexamethasone 0.1 mg/kg and bupivacaine 0.5% - 45 ml

Drug: DexamethasoneDrug: Bupivacaine

Group III (ISB-C)

ACTIVE COMPARATOR

Four nerve blocks without dexamethasone

Drug: Bupivacaine

Interventions

DexamethasoneDRUG
Group I (ISB-P)Group II (ISB-S)
BupivacaineDRUG
Group I (ISB-P)Group II (ISB-S)Group III (ISB-C)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pre-surgical total knee arthroplasty patients

You may not qualify if:

  • Skin infection near block site
  • Allergy to local anesthetics
  • Peripheral neuropathy
  • Proven opioid dependency
  • Coagulopathy
  • Dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

AgnosiaPain, Postoperative

Interventions

DexamethasoneBupivacaine

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPain

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Anatoly Stav, MD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2014

First Posted

October 1, 2014

Study Start

October 1, 2014

Primary Completion

October 1, 2016

Study Completion

October 30, 2017

Last Updated

October 31, 2017

Record last verified: 2014-10

Locations

IL(1)