Fascia Iliaca Compartment Block and PENG Block for Hip Arthroplasty

NCT05030688 | Withdrawn

• 1 other identifier: Medipol Hospital 20
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

Hip arthroplasty is one of the most common orthopedic procedures especially in elderly patients due to deformation of joint. Patients may complain severe pain due to the surgical trauma and the prosthesis. Regional anesthesia methods may be performed to reduce opioid consumption and opioid-related side effects. The hip joint consists of the femoral head and the acetabulum. Sensory innervation of the hip joint is provided by the femoral nerve, obturator nerve, articular branches of the sciatic nerve, and superior gluteal nerve. Because of the increasing use of ultrasound (US) in anesthesia practice, US-guided nerve blocks are widely used. One of the most used methods in the management of analgesia after hip surgery is the fascia iliaca compartment block (FICB). Pericapsular nerve group block (PENG block) is a novel fascial block defined by Arango et al. In this block, it is aimed to block the femoral nerve and the accessory obturatory nerve by injecting local anesthetic between the pubic ramus and the psoas tendon. This prospective, multicenter study aimed to compare the efficacy of PENG block and FICB for postoperative analgesia management in patients undergoing hip arthroplasty with a prosthesis. Our primary aim is to compare global recovery scores, and our secondary aim is to evaluate postoperative opioid consumption, pain scores (Numerical Rating Scale-NRS), and side effects (allergic reaction, nausea, vomiting, etc.) related with opioid use.

Conditions

Hip Fractures; Hip Injuries; Hip Arthropathy

Keywords

Hip arthroplasty; Fascia iliaca compartment block; PENG block; Postoperative analgesia

Outcome Measures

Primary Outcomes (1)

• Global recovery scoring system (patient satisfaction scale)

  This scoring system includes evaluating emotional state (12 questions), physical comfort (12 questions), psychological support (7 questions), physical independence (12 questions), and pain (7 questions).

  Change from baseline scores at postoperative 1, 2, 4, 8, 16, and 24 hours

Secondary Outcomes (2)

• Pain scores (Numerical Rating Scale-NRS)

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

• Opioid consumption

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

Study Arms (2)

Group FICB = Fascia iliaca compartment block

ACTIVE COMPARATOR

FICB will be performed with a suprainguinal approach under US guidance. The probe will be placed sagittally to view the ilium and iliacus muscle. The probe will be moved medially and inferiorly along the inguinal ligament to view the femoral artery. The probe will then be moved superiorly and laterally along the inguinal ligament towards the anterior superior iliac crest to reach the lateral aspect of the femoral nerve. The deep circumflex artery will be visualized 1-2 cm cephalad to the inguinal ligament and superficial to the iliac fascia. The needle will be inserted with in-plane method 2-4 cm caudal to the inguinal ligament to reach below the fascia ilica. After the block site is confirmed with 5 ml of saline, 30 ml of local anesthetic solution containing 0.25% bupivacaine will be injected.

Other: Postoperative analgesia management

Group PENG

ACTIVE COMPARATOR

The probe will be placed on the anterior inferior iliac crest in the transverse plane. Then, the pubic ramus will be visualized by rotating 45 degrees. The femoral artery, iliopubic process and psoas muscle will be visualized. The needle will be punctured with the in-plane method to reach between the pubic ramus and the psoas tendon. After the block site is confirmed with 5 ml of saline, 30 ml of local anesthetic solution containing 0.25% bupivacaine will be injected.

Other: Postoperative analgesia management

Interventions

Postoperative analgesia management OTHER

Intravenous 0.5 mg/kg tramodol and 400 mg ibuprofen will be administered to all patients 30 minutes before the end of the surgical procedure. In the postoperative period, patients will be administered ibuprofen iv 400 mg 3x1. If the NRS score is ≥ 4, 0.5 mg kg-1 iv meperidine will be administered as a rescue analgesic.

Group FICB = Fascia iliaca compartment block; Group PENG

Eligibility Criteria

• Age: 50 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 50-80 years, who were scheduled for hip arthroplasty under general anesthesia, will be included in the study.

You may not qualify if:

• history of bleeding diathesis,
• receiving anticoagulant treatment,
• known local anesthetics and opioid allergy,
• infection of the skin at the site of the needle puncture,
• patients who do not accept the procedure

Sponsors & Collaborators

• Medipol University: lead

Study Sites (2)

Istanbul Medipol University Hospital

Istanbul, Bagcilar, 34070, Turkey (Türkiye)

Location

Mugla Sıtkı Kocman University Hospital

Muğla, Turkey (Türkiye)

Location

Related Publications (4)

• O'Reilly N, Desmet M, Kearns R. Fascia iliaca compartment block. BJA Educ. 2019 Jun;19(6):191-197. doi: 10.1016/j.bjae.2019.03.001. Epub 2019 Apr 24. No abstract available.

  PMID: 33456890 BACKGROUND

• Pepe J, Ausman C, Tafti D, Madhani NB. Ultrasound-Guided Fascia Iliaca Compartment Block. 2025 Sep 14. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK518973/

  PMID: 30085515 BACKGROUND

• Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.

  PMID: 30063657 BACKGROUND

• Ciftci B, Ahiskalioglu A, Altintas HM, Tekin B, Sakul BU, Alici HA. A possible mechanism of motor blockade of high volume pericapsular nerve group (PENG) block: A cadaveric study. J Clin Anesth. 2021 Nov;74:110407. doi: 10.1016/j.jclinane.2021.110407. Epub 2021 Jun 24. No abstract available.

  PMID: 34175637 BACKGROUND

MeSH Terms

Conditions

Hip Fractures; Hip Injuries

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Leg Injuries

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
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary researcher

Model Details: There are two models for this study. The first group is fascia iliaca compartment block (FICB). The second one is PENG block group.

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: September 1, 2021
• Study Start: September 23, 2021
• Primary Completion: June 20, 2022
• Study Completion: July 20, 2022
• Last Updated: August 12, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)