NCT06436105

Brief Summary

Patients who will undergo elective total knee arthroplasty surgery under spinal anesthesia will be included in the study according to the postoperative analgesia method applied: Group Control, Group FICB and Group 4in1. Peripheral nerve block will be performed with 30 ml %0.25 bupivacaine for Group FICB and Group 4 in 1 patients. Peripheral nerve block will not be performed on Group Control patients. Patient-controlled analgesia will be given to all three groups in the postoperative period. PCA is a pain palliation method routinely used in all patients postoperatively. NRS score, PCA tramadol consumption, PCA demand, need for additional analgesia, patient satisfaction, nausea and vomiting will be monitored 24 hours postoperatively. The aim of this study is to compare the perioperative analgesic effectiveness of patients who underwent fascia iliaca compartment block and 4 in 1 block in total knee arthroplasty surgery, with each other and with the control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

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

May 24, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 30, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

May 30, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2024

Completed
Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

1 month

First QC Date

May 24, 2024

Last Update Submit

June 25, 2025

Conditions

Pain, Postoperative

Keywords

FICB4 in 1 blockTotal knee arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Total tramadol consumption in 24 hours (mg)

    Total tramadol consumption used in the first 24 hours postoperatively

    24 hours postoperatively

Secondary Outcomes (8)

  • Pain on the Numeric Rating Scale (NRS)

    0 hours postoperatively

  • Pain on the Numeric Rating Scale (NRS)

    1 hours postoperatively

  • Pain on the Numeric Rating Scale (NRS)

    4 hours postoperatively

  • Pain on the Numeric Rating Scale (NRS)

    8 hours postoperatively

  • Pain on the Numeric Rating Scale (NRS)

    12 hours postoperatively

  • +3 more secondary outcomes

Study Arms (3)

Group Control

OTHER

Peripheral nerve block will not be performed on Group Control patients.

Other: Control

Group FICB

OTHER

FICB will be performed with 30 ml %0.25 bupivacaine for Group FICB patients.

Other: FICB

Group 4 IN 1

OTHER

4 in 1 block will be performed with 30 ml %0.25 bupivacaine for Group 4 IN 1 patients.

Other: 4 in 1 block

Interventions

FICBOTHER

FICB is applied to the patients after spinal anesthesia.

Group FICB
4 in 1 blockOTHER

4 in 1 block is applied to the patients after spinal anesthesia.

Group 4 IN 1
ControlOTHER

Peripheral nerve block will not be performed on Group Control patients.

Group Control

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • With informed consent
  • Elective total knee arthroplasty with spinal anesthesia
  • Oriented and cooperative
  • ASA Classification I-II-III
  • years old

You may not qualify if:

  • Anticoagulant medication
  • Coagulopathy
  • Infection at the site of peripheral nerve block application
  • Allergy to local anesthetics
  • Pregnant or suspected pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Reanimation, University of Health Sciences, Diskapi Yıldırım Beyazit Training and Research Hospital

Ankara, 06450, Turkey (Türkiye)

Location

Related Publications (2)

  • Roy R, Agarwal G, Pradhan C, Kuanardr D, Mallick DJ. Ultrasound guided 4 in 1 block - a newer, single injection technique for complete postoperative analgesia for knee and below knee surgeries. Anaesthesia, Pain & Intensive Care. 2018;22(1):87-92.

    BACKGROUND

  • Kanadli H, Dogru S, Karaman T, Karaman S, Tapar H, Sahin A, Asci M, Kanadli KA, Suren M. Comparison of the efficacy of femoral nerve block and fascia iliaca compartment block in patients with total knee replacement. Minerva Anestesiol. 2018 Oct;84(10):1134-1141. doi: 10.23736/S0375-9393.18.12062-1. Epub 2018 Jan 16.

    PMID: 29338141RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 24, 2024

First Posted

May 30, 2024

Study Start

May 30, 2024

Primary Completion

July 1, 2024

Study Completion

July 8, 2024

Last Updated

June 29, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)