Suprainguinal Fascia Iliaca Block vs. Periarticular Injection for Total Knee Arthroplasty

June 15, 2023 updated by: Elif Oral Ahiskalioglu, Ataturk University

Ultrasound Guided Suprainguinal Fascia Iliaca Block vs. Periarticular Injection for Total Knee Arthroplasty: Prospective Randomized Study

Total knee replacement (total knee arthroplasty) is performed to resurface a knee damaged by arthritis and relieve pain in patients with severely damaged knee joints.

Total knee arthroplasty (TKA) is associated with severe postoperative pain, and the management of postoperative pain continues to evolve with the advancement of surgical techniques and pharmacological treatments.

Femoral, lateral femoral cutaneous nerve and obturator nerve block is provided with suprainguinal fascia iliaca plan block, which is used for postoperative analgesia, especially in hip surgeries. In this way, the investigators think it can be used as a part of multimodal analgesia in total knee arthroplasty surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

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 Locations

  • Turkey
      • Erzurum, Turkey, 25100
        • Ali Ahiskalioglu

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • American Society of Anesthesiologist's physiologic state I-III patients
  • Total knee arthroplasty

Exclusion Criteria:

  • BMI>35
  • liver, kidney, and advanced heart failure,
  • routine use of analgesics and
  • having used analgesics in the last 24 hours,
  • having neuropathic pain,
  • refusal to participate in the study

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group Suprainguinal fascia iliaca block
Suprainguinal fascia iliaca block after the surgery
Other: Group Suprainguinal fascia iliaca block
After the operation is completed, the fascia iliaca will be separated from the iliacus muscle. With ultrasound guidance, the local anesthetic injection will be made between the fascia and the muscle.
Active Comparator: Group Periarticular Infiltration Group
A local anesthetic will be applied to the medial and lateral capsule, the medial and lateral meniscus margins, the deep part of the medial ligament, the medial and lateral synovial space, and the patellar ligament and quadriceps tendon.
Other: Group Periarticular Infiltration
A total volume of 80 ml local anesthetic will be applied to the medial and lateral capsule, the medial and lateral meniscus margins, the deep part of the medial ligament, the medial and lateral synovial space, and the patellar ligament and quadriceps tendon.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative opioid consumption
Time Frame: first 24 hours
First 24 hours total fentanyl consumption with patient controlled analgesia
first 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analog pain score
Time Frame: first 48 hours
Post operative pain will be evaluated with a Visual Analogue Scale (between 0-10; 0: no pain, 10:worst pain) score
first 48 hours
timed up and go test (TUG)
Time Frame: at 24th hour
TUG- evaluation of the time in seconds for the patient to get up from the chair and walk 3 meters and return to the chair again
at 24th hour
quadriceps muscle strength
Time Frame: at 24th hour
will be evaluated in a scale between 1-5 (1:lowest; 5:normal)
at 24th hour
joint range of motion test (ROM)
Time Frame: at 24th hour
will be measured with goniometer( between 0-180 degrees)
at 24th hour
Five Time Sit to Stand Test (FTSST)
Time Frame: at 24th hour
physical assistance of the patient getting up and sitting down 'as fast as possible' five times without
at 24th hour

Collaborators and Investigators

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

Sponsor

Ataturk University

Investigators

  • Study Director: Elif Oral Ahiskalioglu, Ataturk University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

November 25, 2022

Primary Completion (Actual)

May 15, 2023

Study Completion (Actual)

May 30, 2023

Study Registration Dates

First Submitted

November 15, 2022

First Submitted That Met QC Criteria

November 23, 2022

First Posted (Actual)

December 5, 2022

Study Record Updates

Last Update Posted (Estimated)

June 16, 2023

Last Update Submitted That Met QC Criteria

June 15, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • ataunikneesurgery

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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