NCT05636449

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

November 25, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 5, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

6 months

First QC Date

November 15, 2022

Last Update Submit

June 15, 2023

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

  • Postoperative opioid consumption

    First 24 hours total fentanyl consumption with patient controlled analgesia

    first 24 hours

Secondary Outcomes (5)

  • Visual analog pain score

    first 48 hours

  • timed up and go test (TUG)

    at 24th hour

  • quadriceps muscle strength

    at 24th hour

  • joint range of motion test (ROM)

    at 24th hour

  • Five Time Sit to Stand Test (FTSST)

    at 24th hour

Study Arms (2)

Group Suprainguinal fascia iliaca block

ACTIVE COMPARATOR

Suprainguinal fascia iliaca block after the surgery

Other: Group Suprainguinal fascia iliaca block

Group Periarticular Infiltration Group

ACTIVE COMPARATOR

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

Interventions

Group Suprainguinal fascia iliaca blockOTHER

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.

Group Suprainguinal fascia iliaca block
Group Periarticular InfiltrationOTHER

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.

Group Periarticular Infiltration Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ali Ahiskalioglu

Erzurum, 25100, Turkey (Türkiye)

Location

Related Publications (2)

  • Suarez JC, Al-Mansoori AA, Kanwar S, Semien GA, Villa JM, McNamara CA, Patel PD. Effectiveness of Novel Adjuncts in Pain Management Following Total Knee Arthroplasty: A Randomized Clinical Trial. J Arthroplasty. 2018 Jul;33(7S):S136-S141. doi: 10.1016/j.arth.2018.02.088. Epub 2018 Mar 12.

    PMID: 29628196BACKGROUND

  • Bravo D, Layera S, Aliste J, Jara A, Fernandez D, Barrientos C, Wulf R, Munoz G, Finlayson RJ, Tran Q. Lumbar plexus block versus suprainguinal fascia iliaca block for total hip arthroplasty: A single-blinded, randomized trial. J Clin Anesth. 2020 Nov;66:109907. doi: 10.1016/j.jclinane.2020.109907. Epub 2020 Jun 2.

    PMID: 32502775BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Elif Oral Ahiskalioglu

    Ataturk University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 15, 2022

First Posted

December 5, 2022

Study Start

November 25, 2022

Primary Completion

May 15, 2023

Study Completion

May 30, 2023

Last Updated

June 18, 2023

Record last verified: 2023-06

Locations

TU(1)