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Fascia Iliaca Compartment Block and PENG Block for Hip Arthroplasty

Primary Purpose

Hip Fractures, Hip Injuries, Hip Arthropathy

Status
Withdrawn
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Postoperative analgesia management
Sponsored by
Medipol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures focused on measuring Hip arthroplasty, Fascia iliaca compartment block, PENG block, Postoperative analgesia

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Istanbul Medipol University Hospital
  • Mugla Sıtkı Kocman University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group FICB = Fascia iliaca compartment block

Group PENG

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Pain scores (Numerical Rating Scale-NRS)
Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores will be recorded at postoperative 1, 2, 4, 8, 16 and 24 hours
Opioid consumption
If the NRS score is ≥ 4, 0.5 mg kg-1 iv meperidine will be administered as a rescue analgesic.

Full Information

First Posted
August 20, 2021
Last Updated
August 10, 2022
Sponsor
Medipol University
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1. Study Identification

Unique Protocol Identification Number
NCT05030688
Brief Title
Fascia Iliaca Compartment Block and PENG Block for Hip Arthroplasty
Official Title
Comparison of the Effect of Ultrasound-guided Fascia Iliaca Compartment Block and PENG Block on Postoperative Analgesia Management in Patients Undergoing Hip Arthroplasty: A Multicentric, Randomized, Prospective Study.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Withdrawn
Why Stopped
No participant
Study Start Date
September 23, 2021 (Actual)
Primary Completion Date
June 20, 2022 (Actual)
Study Completion Date
July 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medipol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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. Opioid agents are commonly used for analgesia management. However, opioids have adverse effects such as nausea, vomiting, sedation and respiratory depression. 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. Skin innervation of the lateral femur is provided by the lateral cutaneous femoral nerve. The upper anterior part of the thigh is innervated by the genitofemoral and ilioinguinal nerves. These nerves originate from the lumbar and sacral plexus. The innervation of the hip joint is complex, and the selection of the blocking technique is important after these operations. 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). FICB was first described in 1989 by Dalens et al. defined by. It is a popular regional anesthetic technique for surgical procedures involving the hip joint and femur. Since the local anesthetic agent is injected proximally under the fascia ilica, FICB can be considered as the anterior approach of the lumbar plexus blockade. It blocks the femoral nerve, obturator nerve, and lateral cutaneous femoral nerve. There are studies in the literature reporting that it provides effective analgesia after hip surgery. 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. By blocking these nerves, anterior hip analgesia is provided. It is a safe and effective method as it is applied superficially and under ultrasound guidance. In radiological and cadaver studies, it has been reported that total hip analgesia can be provided by blocking the lateral femoral cutaneous, genitofemoral, obturator, and femoral nerves when high volume is applied. Studies evaluating PENG block efficacy are limited in the literature. There is a study comparing PENG block and femoral nerve block, but there is no study comparing it with FICB yet. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Hip Injuries, Hip Arthropathy
Keywords
Hip arthroplasty, Fascia iliaca compartment block, PENG block, Postoperative analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There are two models for this study. The first group is fascia iliaca compartment block (FICB). The second one is PENG block group.
Masking
ParticipantOutcomes Assessor
Masking Description
The patient, and the outcomes assessor who performs postoperative pain evaluation will not know the group.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group FICB = Fascia iliaca compartment block
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group PENG
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Postoperative analgesia management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Global recovery scoring system (patient satisfaction scale)
Description
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).
Time Frame
Change from baseline scores at postoperative 1, 2, 4, 8, 16, and 24 hours
Secondary Outcome Measure Information:
Title
Pain scores (Numerical Rating Scale-NRS)
Description
Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores will be recorded at postoperative 1, 2, 4, 8, 16 and 24 hours
Time Frame
Postoperative 1, 2, 4, 8, 16, and 24 hours
Title
Opioid consumption
Description
If the NRS score is ≥ 4, 0.5 mg kg-1 iv meperidine will be administered as a rescue analgesic.
Time Frame
Postoperative 1, 2, 4, 8, 16, and 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Facility Information:
Facility Name
Istanbul Medipol University Hospital
City
Istanbul
State/Province
Bagcilar
ZIP/Postal Code
34070
Country
Turkey
Facility Name
Mugla Sıtkı Kocman University Hospital
City
Muğla
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The investigator's will not share IPD
Citations:
PubMed Identifier
33456890
Citation
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.
Results Reference
background
PubMed Identifier
30085515
Citation
Pepe J, Ausman C, Madhani NB. Ultrasound-Guided Fascia Iliaca Compartment Block. 2023 Jul 24. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK518973/
Results Reference
background
PubMed Identifier
30063657
Citation
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.
Results Reference
background
PubMed Identifier
34175637
Citation
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.
Results Reference
background

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Fascia Iliaca Compartment Block and PENG Block for Hip Arthroplasty

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