NCT02047331

Brief Summary

In this study, the aim is to compare the efficacy of Periarticular multimodal drug injection(group PI) and Fascia Iliaca Compartment Block ( group FI)for total knee arthroplasty.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 28, 2014

Completed
Last Updated

January 28, 2014

Status Verified

January 1, 2014

Enrollment Period

5 months

First QC Date

January 23, 2014

Last Update Submit

January 27, 2014

Conditions

Total Knee Arthroplasty

Keywords

periarticular drug injectionfascia iliaca blockknee arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain scores of periarticular injection and fascia block for total knee arthroplasty

    Patients were assigned in two groups to perform either periarticular injection (group PI) and fascia block ( group FB). They were accessed by visual analog scale. The aim was to compare the efficacy and side effects of periarticular injection and fascia block.

    postoperative 24 hours

Study Arms (2)

group PI

ACTIVE COMPARATOR

group PI were performed periarticular drug injection during surgery.

Procedure: periarticular injection

group FI

ACTIVE COMPARATOR

group FI were performed fascia iliaca block before surgery

Procedure: fascia iliaca block

Interventions

periarticular injectionPROCEDURE

patients were performed bupivacaine solution to the periarticular soft tissues during surgery by the surgeon.

group PI
fascia iliaca blockPROCEDURE

patients were performed fascia iliaca block with bupivacaine solution before surgery.

group FI

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing knee arthroplasty
  • \> 18 years of age

You may not qualify if:

  • obesity
  • heart failure
  • kidney failure
  • liver failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University School of Medicine Adana Teaching and reserach Hospital

Adana, 01250, Turkey (Türkiye)

Location

Study Officials

  • Anis Aribogan, Prof.,MD

    Baskent University School of Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,Anesthesiology and Reanimation

Study Record Dates

First Submitted

January 23, 2014

First Posted

January 28, 2014

Study Start

February 1, 2013

Primary Completion

July 1, 2013

Study Completion

August 1, 2013

Last Updated

January 28, 2014

Record last verified: 2014-01

Locations

TU(1)