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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02090790
Other study ID # 2013/400
Secondary ID
Status Recruiting
Phase Phase 4
First received March 17, 2014
Last updated March 20, 2014
Start date March 2014
Est. completion date July 2014

Study information

Verified date March 2014
Source TC Erciyes University
Contact ahmet öner, resident
Phone +9055059504112
Email dr_ahmetoner@hotmail.com
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date July 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
iv dexamethasone
2 ml 8 mg iv dexamethasone
femoral dexamethasone
2ml 8mg dexamethasone administration added 30 ml 0,5 % bupivacain
serum physiologic
2 ml iv serum physiologic

Locations

Country Name City State
Turkey Erciyes Univercity Hospital Kayseri

Sponsors (1)

Lead Sponsor Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary visual analog scale postoperative 2 day No
Secondary analgesic consumption morphine consumption (patient controlled analgesia procedure) postoperative 2 day No
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