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

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02090790
• Other study ID #: 2013/400
• 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

• Pain, Postoperative
• Postoperative Pain

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