Fascia Iliaca Compartment Block and IPACK Block in Total Knee Arthroplasty

NCT06125067 | Completed

• 1 other identifier: 2012-KAEK-15/2719
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators sought to compare the effectiveness of postoperative pain control between the standard intravenous multimodal analgesia procedure used in managing patients undergoing total knee surgery, who experience severe postoperative analgesia needs, and multimodal analgesia procedures that incorporate ultrasound-guided peripheral nerve blocks (Fascia Iliaca Compartment Block or iPACK Block) during postoperative follow-up. The aim is to determine which procedure is more effective.

Conditions

Arthropathy of Knee; Analgesia

Keywords

Total Knee Arthroplasty; iPACK Block; Fascia Iliaca Compartment Block; Postoperative Pain; Peripheral Nerve Block

Outcome Measures

Primary Outcomes (1)

• Numerical Rating Scale (NRS)

  NRS was used to assess postoperative pain. The NRS is a segmented numerical version of the visual analog scale (VAS), in which the respondent chooses an integer (0-10 integer) that best reflects the intensity of his pain. It is considered a one-dimensional measure of pain intensity in adults. It is an 11-point numerical scale. It ranges from "0" representing no pain to "10" representing extreme pain.

  postoperative 24 hours score change

Secondary Outcomes (1)

• 5-point likert satisfaction scale

  postoperative 24th hour

Study Arms (3)

Control Group (no peripheral block applied)

No peripheral block was applied to this group and it was accepted as the control group. Standard multimodal analgesia and rescue analgesia according to NRS score were applied to each group

Procedure: no peripheral block

Fascia Iliaca Compartment Block Group

Fascia Iliaca Compartment block was applied to this group under ultrasound guidance. Standard multimodal analgesia and rescue analgesia according to NRS score were applied to each group.

Procedure: Fascia Iliaca Compartment Block

iPACK Block Group

iPACK block was applied to this group under ultrasound guidance. Standard multimodal analgesia and rescue analgesia according to NRS score were applied to each group.

Procedure: iPACK Block

Interventions

no peripheral block PROCEDURE

No peripheral block was applied. Standard multimodal analgesia method was applied.

Control Group (no peripheral block applied)

Fascia Iliaca Compartment Block PROCEDURE

Fascia Iliaca Compartment Block is performed with the patient in a supine position. A high-frequency (6-14 MHz) linear ultrasound probe is positioned transversely to locate the femoral artery in the inguinal crease. The hyperechoic femoral nerve is usually visualized lateral to the femoral artery, between the iliopsoas and fascia iliaca. The probe is manoeuvred in a cranial and caudal direction to capture high-quality images of the femoral nerve and fascia iliaca. Identification of the triangular-shaped sartorius muscle and anterior superior iliac spine (ASIS) is achieved by lateral movement of the probe. Post-skin disinfection, the needle tip is directed just beneath the fascia iliaca. Local anaesthetic is administered following negative pressure aspiration into the area. The local anaesthetic spreads towards the femoral nerve medially and towards the iliac process laterally.

Fascia Iliaca Compartment Block Group

iPACK Block PROCEDURE

During the iPACK procedure, the patient assumes a supine position with the lower extremity flexed at the knee and abducted at the hip (in frog-leg position). The ultrasound transducer is placed in the lower third of the medial thigh, and then pushed backward and downward to visualize the gap between the popliteal artery and the femoral shaft, straight above the femoral condyles. After ensuring that the needle tip is placed 2 cm beyond the lateral border of the artery, local anaesthetic solution is administrated in divided doses to infiltrate the tissue space. The needle is then withdrawn after confirming negative aspiration.

iPACK Block Group

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In our study, which is planned as a retrospective file scanning and postoperative regional anesthesia follow-up form review, all patients who have undergone elective total knee arthroplasty surgery of Ankara Atatürk Sanatorium Training and Research Hospital in the last 1 year (between 01 March 2022 and 31 March 2023) will be included in the study. It is planned to examine 120 patient files in total.

You may qualify if:

• Patients who have undergone elective total knee surgery
• ASA I-III patients

You may not qualify if:

• Those \<30 kg
• People under 18 years of age
• Patients with missing follow-up forms
• Patients with a history of chronic opioid or corticosteroid use
• Patients with a history of inflammatory gonathrosis
• Patients with synovectomy operation history

Sponsors & Collaborators

• Ankara Ataturk Sanatorium Training and Research Hospital: lead

Study Sites (1)

Ankara Atatürk Sanatorium Training and Research Hospital

Ankara, Keçiören, 06290, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Study Officials

• Onur KÜÇÜK, specialist

  Ankara Ataturk Sanatorium Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of anesthesiology and reanimation, Principal Investigator, Specialist Doctor

Study Record Dates

• First Submitted: November 4, 2023
• First Posted: November 9, 2023
• Study Start: April 1, 2024
• Primary Completion: July 31, 2024
• Study Completion: December 1, 2024
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)