- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05030688
Fascia Iliaca Compartment Block and PENG Block for Hip Arthroplasty
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Muğla, Turkey
- Mugla Sıtkı Kocman University Hospital
-
-
Bagcilar
-
Istanbul, Bagcilar, Turkey, 34070
- Istanbul Medipol University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group FICB = Fascia iliaca compartment block
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.
|
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.
|
Active Comparator: Group PENG
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Global recovery scoring system (patient satisfaction scale)
Time Frame: Change from baseline scores at postoperative 1, 2, 4, 8, 16, and 24 hours
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain scores (Numerical Rating Scale-NRS)
Time Frame: Postoperative 1, 2, 4, 8, 16, and 24 hours
|
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
|
Postoperative 1, 2, 4, 8, 16, and 24 hours
|
Opioid consumption
Time Frame: Postoperative 1, 2, 4, 8, 16, and 24 hours
|
If the NRS score is ≥ 4, 0.5 mg kg-1 iv meperidine will be administered as a rescue analgesic.
|
Postoperative 1, 2, 4, 8, 16, and 24 hours
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- Pepe J, Ausman C, Madhani NB. Ultrasound-guided Fascia Iliaca Compartment Block. 2022 Jul 25. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK518973/
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Medipol Hospital 20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hip Fractures
-
Smith & Nephew, Inc.Terminated
-
Carilion ClinicCompleted
-
Texas Tech University Health Sciences Center, El...CompletedHip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)United States
-
FH ORTHORecruitingHip Fractures | Hip DiseaseFrance
-
Zhenjiang First People's HospitalCompletedHip Fractures | Hip DiseaseChina
-
Bayside HealthCompleted
-
Oslo University HospitalDiakonhjemmet HospitalCompletedHip Fractures | Trochanteric Fractures | Intertrochanteric FracturesNorway
-
Tel-Aviv Sourasky Medical CenterUnknownIntertrochanteric Fractures of the HipIsrael
-
University of Missouri-ColumbiaUniversity of Alabama at Birmingham; Medical College of Wisconsin; University...CompletedHip Fractures | Pelvic Fractures | Acetabular FracturesUnited States
-
Rabin Medical CenterUnknown
Clinical Trials on Postoperative analgesia management
-
Taipei City HospitalCompletedPain, Postoperative | Epidural Anesthesia | Lumbar Spine Degeneration | Analgesia, Patient-ControlledTaiwan
-
Huazhong University of Science and TechnologyCompletedPostoperative Pain, Acute
-
Bursa City HospitalRecruiting
-
Mursel EkinciCompletedKnee Osteoarthritis | Knee Arthritis | Knee DiseaseTurkey
-
Medipol UniversityRecruiting
-
Medipol UniversityWithdrawnKnee Osteoarthritis | Knee Arthropathy | Knee Pain Chronic | Knee Deformity | Knee DiseaseTurkey
-
Medipol UniversityRecruitingHip Fractures | Hip Injuries | Hip ArthropathyTurkey
-
Medipol UniversityRecruitingKnee Osteoarthritis | Knee Injuries | Knee Arthritis | Knee DiseaseTurkey
-
Beijing Children's HospitalUnknownSpinal Puncture Complications
-
Mursel EkinciAhmet Kaciroglu; Mustafa DikiciRecruiting