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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02047331
Other study ID # KA12/269
Secondary ID
Status Completed
Phase Phase 4
First received January 23, 2014
Last updated January 27, 2014
Start date February 2013
Est. completion date August 2013

Study information

Verified date January 2014
Source Baskent University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Interventional

Clinical Trial 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.


Description:

Total knee arthroplasty is very painful surgical intervention.Patients were assigned to 2 groups to receive either periarticular multimodal drug injection or fascia iliaca compartment block for postoperative pain.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date August 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- patients undergoing knee arthroplasty

- > 18 years of age

Exclusion Criteria:

- obesity

- heart failure

- kidney failure

- liver failure

Study Design

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


Related Conditions & MeSH terms


Intervention

Procedure:
periarticular injection
patients were performed bupivacaine solution to the periarticular soft tissues during surgery by the surgeon.
fascia iliaca block
patients were performed fascia iliaca block with bupivacaine solution before surgery.

Locations

Country Name City State
Turkey Baskent University School of Medicine Adana Teaching and reserach Hospital Adana

Sponsors (1)

Lead Sponsor Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
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