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

March 20, 2014 updated by: ahmet öner, TC Erciyes University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: iv dexamethasone
perioperative 2ml 8 mg ıv dexamethasone
Drug: iv dexamethasone
2 ml 8 mg iv dexamethasone
Other Names:
  • decort
Active Comparator: femoral dexamethasone
femoral block was performed postoperative 30 ml 0,5 % bupivacaine added 2 ml 8 mg dexamethasone
Drug: femoral dexamethasone
2ml 8mg dexamethasone administration added 30 ml 0,5 % bupivacain
Other Names:
  • dekort
Placebo Comparator: serum physiologic
Drug: serum physiologic
2 ml iv serum physiologic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
visual analog scale
Time Frame: postoperative 2 day
postoperative 2 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
analgesic consumption
Time Frame: postoperative 2 day
morphine consumption (patient controlled analgesia procedure)
postoperative 2 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TC Erciyes University

Investigators

  • Principal Investigator: ahmet öner, recident, erciyes univercity
  • Study Director: gülen güler, prof, erciyes univercity

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

July 1, 2014

Study Registration Dates

First Submitted

March 17, 2014

First Submitted That Met QC Criteria

March 17, 2014

First Posted (Estimate)

March 18, 2014

Study Record Updates

Last Update Posted (Estimate)

March 21, 2014

Last Update Submitted That Met QC Criteria

March 20, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/400

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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