NCT02090790

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4 postoperative-pain

Timeline
Completed

Started Mar 2014

Shorter than P25 for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

March 21, 2014

Status Verified

March 1, 2014

Enrollment Period

3 months

First QC Date

March 17, 2014

Last Update Submit

March 20, 2014

Conditions

Keywords

dexamethasonefemoral blocktotal knee arthroplasty

Outcome Measures

Primary Outcomes (1)

  • visual analog scale

    postoperative 2 day

Secondary Outcomes (1)

  • analgesic consumption

    postoperative 2 day

Study Arms (3)

iv dexamethasone

ACTIVE COMPARATOR

perioperative 2ml 8 mg ıv dexamethasone

Drug: iv dexamethasone

femoral dexamethasone

ACTIVE COMPARATOR

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

Drug: femoral dexamethasone

serum physiologic

PLACEBO COMPARATOR
Drug: serum physiologic

Interventions

2 ml 8 mg iv dexamethasone

Also known as: decort
iv dexamethasone

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

Also known as: dekort
femoral dexamethasone

2 ml iv serum physiologic

serum physiologic

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes Univercity Hospital

Kayseri, 38039, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • ahmet öner, recident

    erciyes univercity

    PRINCIPAL INVESTIGATOR
  • gülen güler, prof

    erciyes univercity

    STUDY DIRECTOR

Central Study Contacts

ahmet öner, resident

CONTACT

gülen güler, prof

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident

Study Record Dates

First Submitted

March 17, 2014

First Posted

March 18, 2014

Study Start

March 1, 2014

Primary Completion

June 1, 2014

Study Completion

July 1, 2014

Last Updated

March 21, 2014

Record last verified: 2014-03

Locations