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Comparison Between Perineural and Systemic Effect of Dexamethasone as an Adjuvant for Prolongation of Four Nerve Blocks With Bupivacaine in Total Knee Arthroplasty

Primary Purpose

Analgesia, Pain, Postoperative

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Dexamethasone

Bupivacaine

About this trial

This is an interventional treatment trial for Analgesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Pre-surgical total knee arthroplasty patients

Exclusion Criteria:

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

Sites / Locations

Hillel Yaffe Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Group I (ISB-P)

Group II (ISB-S)

Group III (ISB-C)

Arm Description

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

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

Four nerve blocks without dexamethasone

Outcomes

Primary Outcome Measures

Efficacy Perineural DxaM

Duration of motor and sensory block

Secondary Outcome Measures

Efficacy of Systemic DxaM

Duration of motor and sensory block

Full Information

NCT ID

NCT02253784

First Posted

September 29, 2014

Last Updated

October 30, 2017

Sponsor

Hillel Yaffe Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02253784

Brief Title

Comparison Between Perineural and Systemic Effect of Dexamethasone as an Adjuvant for Prolongation of Four Nerve Blocks With Bupivacaine in Total Knee Arthroplasty

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

October 2014 (undefined)

Primary Completion Date

October 2016 (Actual)

Study Completion Date

October 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hillel Yaffe Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Analgesia, Pain, Postoperative

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group I (ISB-P)

Arm Type

Active Comparator

Arm Description

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

Arm Title

Group II (ISB-S)

Arm Type

Active Comparator

Arm Description

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

Arm Title

Group III (ISB-C)

Arm Type

Active Comparator

Arm Description

Four nerve blocks without dexamethasone

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Type

Drug

Intervention Name(s)

Bupivacaine

Primary Outcome Measure Information:

Title

Efficacy Perineural DxaM

Description

Duration of motor and sensory block

Time Frame

One day

Secondary Outcome Measure Information:

Title

Efficacy of Systemic DxaM

Description

Duration of motor and sensory block

Time Frame

One day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pre-surgical total knee arthroplasty patients Exclusion Criteria: Skin infection near block site Allergy to local anesthetics Peripheral neuropathy Proven opioid dependency Coagulopathy Dementia

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anatoly Stav, MD

Organizational Affiliation

Hillel Yaffe Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hillel Yaffe Medical Center

City

Hadera

ZIP/Postal Code

38100

Country

Israel

12. IPD Sharing Statement

Learn more about this trial

Comparison Between Perineural and Systemic Effect of Dexamethasone as an Adjuvant for Prolongation of Four Nerve Blocks With Bupivacaine in Total Knee Arthroplasty

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