ESPB vs FICB for Pain Management Following Total Hip Prosthesis Surgery

NCT05621161 | Completed

• 1 other identifier: BursaCityH1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis; Knee Disease; Knee Arthritis

Keywords

Total hip prosthesis surgery; Postoperative analgesia; Erector spina plan block; Fascia iliaca compartment block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Postoperative pain score

  Postoperative 1, 2, 4, 8, 16 and 24 hours

Study Arms (2)

GroupFICB= fascia iliaca compartment block

ACTIVE COMPARATOR

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

Group ESPB = erector spina plan block

ACTIVE COMPARATOR

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

Interventions

Postoperative analgesia management DRUG

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.

Group ESPB = erector spina plan block; GroupFICB= fascia iliaca compartment block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mursel Ekinci: lead

Study Sites (1)

Mursel Ekinci

Bursa, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 30922995 BACKGROUND

• 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.

  PMID: 29149734 BACKGROUND

• 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.

  PMID: 25551810 BACKGROUND

• Kaciroglu A, Ekinci M, Dikici M, Aydemir O, Demiroluk O, Erdogan D, Golboyu BE, Alver S, Ciftci B, Gurbuz H. Lumbar erector spinae plane block versus infrainguinal fascia iliaca compartment block for pain management after total hip arthroplasty: a randomized clinical trial. Pain Med. 2024 Apr 3;25(4):257-262. doi: 10.1093/pm/pnad166.

  PMID: 38127974 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient and the outcomes assessor who performs postoperative pain evaluation will not know the group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: There are two models for this study. Fascia iliaca compartment block (FICB) group, and Erector spinae plane block (ESPB) group

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 17, 2022
• Study Start: November 28, 2022
• Primary Completion: August 15, 2023
• Study Completion: September 15, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)