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Comparison of Analgesic Consumption Between Perioperative ıv Dexamethasone and Added to Femoral Block

Primary Purpose

Postoperative Pain

Status

Unknown status

Phase

Phase 4

Locations

Turkey

Study Type

Interventional

Intervention

iv dexamethasone

femoral dexamethasone

serum physiologic

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring dexamethasone, femoral block, total knee arthroplasty

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

between 18-65 age
knee arthroplasty
no known allergies to drugs
ASA 1-2 patients

Exclusion Criteria:

history of diabetes
history of chronic pain treatment
pregnancy
severe bronchopulmonary disease
systemic opioid and steroid use

Sites / Locations

Erciyes Univercity HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

iv dexamethasone

femoral dexamethasone

serum physiologic

Arm Description

perioperative 2ml 8 mg ıv dexamethasone

femoral block was performed postoperative 30 ml 0,5 % bupivacaine added 2 ml 8 mg dexamethasone

Outcomes

Primary Outcome Measures

visual analog scale

Secondary Outcome Measures

analgesic consumption

morphine consumption (patient controlled analgesia procedure)

Full Information

NCT ID

NCT02090790

First Posted

March 17, 2014

Last Updated

March 20, 2014

Sponsor

TC Erciyes University

1. Study Identification

Unique Protocol Identification Number

NCT02090790

Brief Title

Comparison of Analgesic Consumption Between Perioperative ıv Dexamethasone and Added to Femoral Block

Official Title

The Compare the Effect of Peroperative Intravenous Single Dose Dexamethasone and the Addition of Dexamethasone to Femoral Nerve Block on Postoperative Analgesic Consumption Anf Patient Comfort in Unilateral Total Knee Arthroplasty Patients

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Unknown status

Study Start Date

March 2014 (undefined)

Primary Completion Date

June 2014 (Anticipated)

Study Completion Date

July 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

TC Erciyes University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

the aim of this study was to investigate compare the effect of peroperative intravenous single dose dexamethasone and the addition of dexamethasone to femoral nerve block on postoperative analgesic consumption and patient comfort in unilateral total knee arthroplasty patients

Detailed Description

Total knee arthroplasty leads to severe postoperative pain. for postoperative pain control after total knee arthroplasty oral -intramuscular opioids ,patient controlled analgesia intravenous or epidural opioids, single -continuous femoral nerve block involving techniques are used. Dexamethasone is a glucocorticoid of high potency and frequently used perioperative.Dexamethasone to the local anaesthetic solution administered trough in femoral nerve blocks significantly prolonged the analgesic effect of the local anaesthetics used on this blocks.If the analgesic efficacy of systemic treatment with dexamethasone is similar with the use of perineural wich is the safest way should be preferred for systemic use.

6. Conditions and Keywords

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

Postoperative Pain

Keywords

dexamethasone, femoral block, total knee arthroplasty

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

iv dexamethasone

Arm Type

Active Comparator

Arm Description

perioperative 2ml 8 mg ıv dexamethasone

Arm Title

femoral dexamethasone

Arm Type

Active Comparator

Arm Description

femoral block was performed postoperative 30 ml 0,5 % bupivacaine added 2 ml 8 mg dexamethasone

Arm Title

serum physiologic

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

iv dexamethasone

Other Intervention Name(s)

decort

Intervention Description

2 ml 8 mg iv dexamethasone

Intervention Type

Drug

Intervention Name(s)

femoral dexamethasone

Other Intervention Name(s)

dekort

Intervention Description

2ml 8mg dexamethasone administration added 30 ml 0,5 % bupivacain

Intervention Type

Drug

Intervention Name(s)

serum physiologic

Intervention Description

2 ml iv serum physiologic

Primary Outcome Measure Information:

Title

visual analog scale

Time Frame

postoperative 2 day

Secondary Outcome Measure Information:

Title

analgesic consumption

Description

morphine consumption (patient controlled analgesia procedure)

Time Frame

postoperative 2 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: between 18-65 age knee arthroplasty no known allergies to drugs ASA 1-2 patients Exclusion Criteria: history of diabetes history of chronic pain treatment pregnancy severe bronchopulmonary disease systemic opioid and steroid use

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

ahmet öner, resident

Phone

+9055059504112

dr_ahmetoner@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

gülen güler, prof

Phone

+905327922484

gulen@erciyes.edu.tr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ahmet öner, recident

Organizational Affiliation

erciyes univercity

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

gülen güler, prof

Organizational Affiliation

erciyes univercity

Official's Role

Study Director

Facility Information:

Facility Name

Erciyes Univercity Hospital

City

Kayseri

ZIP/Postal Code

38039

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

ahmet öner, resident

Phone

+905059504112

dr_ahmetoner@hotmail.com

First Name & Middle Initial & Last Name & Degree

gülen güler, prof

Phone

+905327922484

gulen@erciyes.edu.tr

12. IPD Sharing Statement

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Comparison of Analgesic Consumption Between Perioperative ıv Dexamethasone and Added to Femoral Block

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