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

NCT ID: NCT02090790

Last Updated: 2014-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-07-31

Brief Summary

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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

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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iv dexamethasone

perioperative 2ml 8 mg ıv dexamethasone

Group Type ACTIVE_COMPARATOR

iv dexamethasone

Intervention Type DRUG

2 ml 8 mg iv dexamethasone

femoral dexamethasone

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

Group Type ACTIVE_COMPARATOR

femoral dexamethasone

Intervention Type DRUG

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

serum physiologic

Group Type PLACEBO_COMPARATOR

serum physiologic

Intervention Type DRUG

2 ml iv serum physiologic

Interventions

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iv dexamethasone

2 ml 8 mg iv dexamethasone

Intervention Type DRUG

femoral dexamethasone

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

Intervention Type DRUG

serum physiologic

2 ml iv serum physiologic

Intervention Type DRUG

Other Intervention Names

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decort dekort

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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ahmet öner

resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ahmet öner, recident

Role: PRINCIPAL_INVESTIGATOR

erciyes univercity

gülen güler, prof

Role: STUDY_DIRECTOR

erciyes univercity

Locations

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Erciyes Univercity Hospital

Kayseri, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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ahmet öner, resident

Role: CONTACT

+9055059504112

gülen güler, prof

Role: CONTACT

+905327922484

Facility Contacts

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ahmet öner, resident

Role: primary

+905059504112

gülen güler, prof

Role: backup

+905327922484

Other Identifiers

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2013/400

Identifier Type: -

Identifier Source: org_study_id

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