ESPB vs FICB for Pain Management Following Total Hip Prosthesis Surgery

Comparison of Ultrasound-Guided Lumbar Erector Spinae Plane Block And Fascia Iliaca Compartment Block for Pain Management Following Total Hip Prosthesis Surgery

Hip arthroplasty surgery is frequently performed on elderly patients in the community and it is associated with long-term postoperative hospital stays and high mortality.

Postoperative pain management is a multimodal process that includes intravenous and regional anesthesia methods. The ultrasound(US) guided erector spinae plane block (ESPB) is injected with a local anesthetic into the deep fascia of the erector spinae. In the literature, it has been reported that ESPB provides effective analgesia after a hip surgery. The fascia iliaca compartment block (FICB) is a safe method used for postoperative analgesia following hip, femoral, and knee surgeries.

The aim of this study is to compare US-guided FICB and ESPB for postoperative analgesia management after total hip prosthesis surgery.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis; Knee Arthritis; Knee Disease
• Intervention / Treatment: Drug: Postoperative analgesia management

Detailed Description

Hip arthroplasty surgery is frequently performed on elderly patients in the community and it is associated with long-term postoperative hospital stays and high mortality. Severe postoperative pain may further reduce the limited cardiopulmonary capacity, especially in the elderly population. Postoperative effective pain treatment provides early mobilization and shorter hospital stay, thus complications due to hospitalization such as infection and thromboembolism may be reduced.

Postoperative pain management is a multimodal process that includes intravenous and regional anesthesia methods. Parenteral opioids are generally preferred in the management of acute postoperative pain. However, opioids have undesired adverse events such as nausea, vomiting, itching, sedation, and respiratory depression (opioid-related adverse events). Regional anesthesia techniques are frequently preferred as a part of multimodal analgesia in hip surgeries. Various methods may be performed to reduce the use of systemic opioids and for effective pain treatment. US-guided interfascial plane blocks have been used increasingly due to the advantages of ultrasound in anesthesia practice.

The ultrasound(US) guided erector spinae plane block (ESPB) is injected with a local anesthetic into the deep fascia of the erector spinae. Visualization of sonoanatomy with the US is simple and the spread of local anesthetic solution can be seen easily in the deep fascia of the erector spinae. Visualization of sonoanatomy in the US is easy, and the spread of local anesthetic agents can be easily seen under the erector spinae muscle. Thus, analgesia occurs in several dermatomes with cephalad-caudad way. Cadaveric studies have shown that the injection spreads to the ventral and dorsal roots of the spinal nerves. In the literature, it has been reported that ESPB provides effective analgesia after a hip surgery. The fascia iliaca compartment block (FICB) is a safe method used for postoperative analgesia following hip, femoral, and knee surgeries.

The aim of this study is to compare US-guided FICB and ESPB for postoperative analgesia management after total hip prosthesis surgery. The primary aim is to compare perioperative and postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), and adverse effects related to opioids (allergic reaction, nausea, vomiting).

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MÜRSEL EKİNCİ, Assoc prof, MD; Phone Number: +905067137596; Email: drmurselekinci@gmail.com
• Study Contact Backup: Name: AHMET KACIROGLU, MD; Email: akaciroglu@gmail.com

Study Locations

• Turkey
  • Bursa, Turkey
    • Mürsel Ekinci

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with ASA classification I-III
• Aged 18-80 years
• Who will be scheduled for total hip prosthesis surgery under spinal anesthesia

Exclusion Criteria:

• Patients who have a history of bleeding diathesis
• Take anticoagulant therapy
• History of chronic pain before surgery
• Known local anesthetics and opioid allergy
• Pregnancy or lactation
• Infection at the site of block
• Patients who do not accept the procedure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: GroupFICB= fascia iliaca compartment block; ESP block will be performed. US probe will be placed longitudinally 2-3 cm lateral to the L3 transverse process. Erector spinae muscle will be visualized on the hyperechoic transverse process. The block needle (100 mm, 22G) will be inserted cranio-caudal direction and then for correction of the needle 2 ml saline will be injected deep into the erector spinae muscle fascia. Following confirmation of the correct position of the needle 30 ml 0.25% bupivacaine will be administered for the block.	Drug: Postoperative analgesia management; Intravenous paracetamol 1 gr and a dose of 0,5 mg/kg-1 tramadol intravenously will be performed on all patients 30 min before the end of the surgery for postoperative analgesia. Patients will be administered paracetamol 1 gr IV every 8 hours in the postoperative period. A patient-controlled device prepared with 5 mg/ ml tramadol will be attached to all patients with a protocol including 10 mg bolus without infusion dose, 10 min lockout time, and 4-hour limit. If the VAS score will be ≥ 4, 0,5 mg/kg-1 meperidine IV will be administered.
Active Comparator: Group ESPB = erector spina plan block; FIC block will be performed in the supine position. The linear probe is placed transversely to identify the femoral artery, iliopsoas muscle, and fascia iliaca at the inguinal crease. The probe will be tilted cranially and caudally until optimal images of the fascia iliaca are obtained. Block needle (50 mm, 22G) will be passed through the iliac fascia via the in-plane method. Once the needle tip will be placed within the interfacial plane and after careful aspiration to rule out intravascular needle placement, 2 mL of saline will be injected to confirm the proper injection site, and then a dose of 0.25% bupivacaine 30 mL will be injected.	Drug: Postoperative analgesia management; Intravenous paracetamol 1 gr and a dose of 0,5 mg/kg-1 tramadol intravenously will be performed on all patients 30 min before the end of the surgery for postoperative analgesia. Patients will be administered paracetamol 1 gr IV every 8 hours in the postoperative period. A patient-controlled device prepared with 5 mg/ ml tramadol will be attached to all patients with a protocol including 10 mg bolus without infusion dose, 10 min lockout time, and 4-hour limit. If the VAS score will be ≥ 4, 0,5 mg/kg-1 meperidine IV will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption	The tramadol consumption on PCA device will be evaluated	Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain score	Postoperative pain assessment will be performed using the Numerical Rating Scale (0 = no pain, 10 = the most severe pain felt)	Postoperative 1, 2, 4, 8, 16 and 24 hours

Collaborators and Investigators

• Sponsor: Mursel Ekinci

Publications and helpful links

General Publications

• Tulgar S, Senturk O. Ultrasound guided Erector Spinae Plane block at L-4 transverse process level provides effective postoperative analgesia for total hip arthroplasty. J Clin Anesth. 2018 Feb;44:68. doi: 10.1016/j.jclinane.2017.11.006. Epub 2017 Nov 14. No abstract available.
• Gao Y, Tan H, Sun R, Zhu J. Fascia iliaca compartment block reduces pain and opioid consumption after total hip arthroplasty: A systematic review and meta-analysis. Int J Surg. 2019 May;65:70-79. doi: 10.1016/j.ijsu.2019.03.014. Epub 2019 Mar 25.
• Deniz S, Atim A, Kurklu M, Cayci T, Kurt E. Comparison of the postoperative analgesic efficacy of an ultrasound-guided fascia iliaca compartment block versus 3 in 1 block in hip prosthesis surgery. Agri. 2014;26(4):151-7. doi: 10.5505/agri.2014.76993.

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2022
• Primary Completion (Actual): August 15, 2023
• Study Completion (Actual): September 15, 2023

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: November 16, 2022
• First Posted (Actual): November 17, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Postoperative analgesia; Erector spina plan block; Total hip prosthesis surgery; Fascia iliaca compartment block
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: BursaCityH1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No