Fascia Iliaca Compartment Block and IPACK Block in Total Knee Arthroplasty

Comparison of the Efficacy of Fascia Iliaca Compartment Block and IPACK Block for Postoperative Analgesia in Total Knee Arthroplasty Operation

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.

Study Overview

• Status: Completed
• Conditions: Analgesia; Arthropathy of Knee
• Intervention / Treatment: Procedure: no peripheral block; Procedure: Fascia Iliaca Compartment Block; Procedure: iPACK Block

Detailed Description

All patients who received a total knee replacement surgery conducted by orthopaedic surgeons at the operating theatre of Health Sciences University Ankara Atatürk Sanatorium Training and Research Hospital and underwent postoperative pain assessment by anaesthetists will be retrospectively reviewed as part of the study.

Postoperative pain management follow-up for patients who have undergone surgical procedures at Anaesthesiology and Reanimation Clinic is standard practice during patients hospitalization. Patients who have undergone painful and significant surgical procedures are typically given postoperative patient-controlled analgesia devices and are administered intravenous painkillers that are under the patient's control. As part of multimodal analgesia procedure, the investigators apply peripheral nerve blocks routinely to eligible patients, provided that the necessary criteria are met. Once the postoperative Anesthesiology and Reanimation clinic's follow-up form, the regional anaesthesia follow-up form, is completed, patients receive coordinated follow-up care from anaesthesiologists and surgical physicians in postoperative ward to monitor analgesic requirements and increase patient satisfaction. Hourly monitoring ensures that patients receive optimal care.

The aims of study to examine the effectiveness of these procedures. The investigators will include all patients who received elective total knee arthroplasty surgery in the operating room of Ankara Atatürk Sanatorium Training and Research Hospital within the past year (between 01 March 2022 and 31 March 2023) in retrospective file review and postoperative pain follow-up study.

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Turkey
  • Keçiören
    • Ankara, Keçiören, Turkey, 06290
      • ANKARA ATATURK SANATORİUM TRAİNİNG AND RESEARCH HOSPITAL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; No peripheral block was applied. Standard multimodal analgesia method was applied.
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
5-point likert satisfaction scale	The patient's satisfaction with postoperative pain treatment will be recorded. 5 options; very dissatisfied, dissatisfied, neither dissatisfied or satisfied, satisfied, very satisfied	postoperative 24th hour

Collaborators and Investigators

• Sponsor: Ankara Ataturk Sanatorium Training and Research Hospital
• Investigators: Principal Investigator: Onur KÜÇÜK, specialist, ANKARA ATATURK SANATORİUM TRAİNİNG AND RESEARCH HOSPITAL

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): July 31, 2024
• Study Completion (Actual): December 1, 2024

Study Registration Dates

• First Submitted: November 4, 2023
• First Submitted That Met QC Criteria: November 4, 2023
• First Posted (Actual): November 9, 2023

Study Record Updates

• Last Update Posted (Estimated): December 12, 2024
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Postoperative Pain; Total Knee Arthroplasty; Fascia Iliaca Compartment Block; Peripheral Nerve Block; iPACK Block
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: 2012-KAEK-15/2719

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No