- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05397145
Iliopsoas Plane Block vs PENG Block for Hip Arthroplasty
Comparison of the Effect of Ultrasound-guided Iliopsoas Plane Block and PENG Block on Postoperative Analgesia Management in Patients Undergoing Hip Arthroplasty: A 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 joints. Patients may complain of severe pain due to 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 supplied 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 essential after these operations.
Pericapsular nerve group block (PENG block) is a novel fascial block defined by Arango et al. In this block, it is aimed blocking the femoral nerve and the accessory obturator 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.
The iliopsoas plane block (IPB) is a new block defined by Nielsen et al. It does not cause a motor block, but selectively blocks the sensory branches of the hip joint originating from the accessory obturator nerve and the femoral nerve. There is a study showing that it does not cause a motor block in healthy volunteers. Although there are case series in the literature reporting that it provides hip joint analgesia, there is no clinical study yet.
This prospective, randomized study aims to compare the efficacy of PENG block and IPB for postoperative analgesia management in patients undergoing hip arthroplasty with a prosthesis. Our primary aim is to compare postoperative opioid consumption, secondary aim is to evaluate pain scores (Numerical Rating Scale-NRS), quadriceps motor block (paresis or paralysis in knee extension), and side effects (allergic reaction, nausea, vomiting, etc.) associated with opioid use.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bahadir Ciftci, Assoc Prof, MD
- Phone Number: +905343736865
- Email: bciftci@medipol.edu.tr
Study Contact Backup
- Name: Yunus Atalay, Assoc prof, MD
Study Locations
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Bagcilar
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Istanbul, Bagcilar, Turkey, 34070
- Recruiting
- Istanbul Medipol University Hospital
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Contact:
- Bahadir Ciftci, MD
- Phone Number: +905325034428
- Email: bciftci@medipol.edu.tr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with ASA classification I-III,
- Aged 20-80 years
- Who will be scheduled for hip arthroplasty under general anesthesia.
Exclusion Criteria:
- Patients who have a history of bleeding diathesis,
- Take anticoagulant therapy,
- History of chronic pain before surgery,
- Multiple trauma,
- Who cannot assess their pain (dementia),
- Who have been operated under spinal or epidural anesthesia,
- Who have an infection in the area and 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 IPB = Iliopsoas plane block
While the patient is in the supine position, the probe will be placed in the transversal plane distal to the anterior superior iliac spine.
Then, the probe will be rotated approximately 30° counterclockwise and slid along the inguinal ligament until the femoral head enters the edge of the acetabulum.
The block needle will be passed through the sartorius and iliopsoas muscles and the iliopsoas plane between the iliopsoas muscle and the iliofemoral ligament will be reached.
After the block site is confirmed with 5 ml of saline, 10 ml of local anesthetic solution containing 0.25% bupivacaine will be injected.
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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.
Postoperative patient evaluation will be performed by another pain nurse who is unaware of the procedure.
Patients in all groups will be attached to IV PCA containing 10 mcg/ml fentanyl, 10 mcg bolus without infusion dose, 10 min lock time protocol.
If the NRS score is ≥ 4, 0.5 mg kg-1 iv meperidine will be administered as a rescue analgesic.
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Active Comparator: Group PENG = PENG block
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, 20 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.
Postoperative patient evaluation will be performed by another pain nurse who is unaware of the procedure.
Patients in all groups will be attached to IV PCA containing 10 mcg/ml fentanyl, 10 mcg bolus without infusion dose, 10 min lock time protocol.
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 |
---|---|---|
Opioid consumption
Time Frame: Changes from baseline opioid consumption at postoperative 0, 2, 4, 8, 16 and 24 hours.
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The fentanyl consumption on PCA device will be evaluated
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Changes from baseline opioid consumption at postoperative 0, 2, 4, 8, 16 and 24 hours.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain scores (Numerical Rating Scale-NRS)
Time Frame: Changes from baseline pain scores at postoperative 0, 2, 4, 8, 16 and 24 hours
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Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
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Changes from baseline pain scores at postoperative 0, 2, 4, 8, 16 and 24 hours
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Quadriceps muscle strength
Time Frame: Postoperative 24 hours period
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Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the Oxford muscle strength rating
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Postoperative 24 hours period
|
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.
- Lin DY, Morrison C, Brown B, Saies AA, Pawar R, Vermeulen M, Anderson SR, Lee TS, Doornberg J, Kroon HM, Jaarsma RL. Pericapsular nerve group (PENG) block provides improved short-term analgesia compared with the femoral nerve block in hip fracture surgery: a single-center double-blinded randomized comparative trial. Reg Anesth Pain Med. 2021 May;46(5):398-403. doi: 10.1136/rapm-2020-102315. Epub 2021 Feb 26.
- Luo W, Liang J, Wu J, Luo Q, Wu H, Ou Y, Li Y, Ma W. Effects of pericapsular nerve group (PENG) block on postoperative recovery in elderly patients with hip fracture: study protocol for a randomised, parallel controlled, double-blind trial. BMJ Open. 2022 Mar 29;12(3):e051321. doi: 10.1136/bmjopen-2021-051321.
- Yamak Altinpulluk E, Galluccio F, Salazar C, Espinoza K, Olea MS, Hochberg U, de Santiago J, Fajardo Perez M. Peng block in prosthetic hip replacement: A cadaveric radiological evaluation. J Clin Anesth. 2020 Oct;65:109888. doi: 10.1016/j.jclinane.2020.109888. Epub 2020 May 21. No abstract available.
- 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.
- Wang CG, Yang Y, Yang MY, Wang XL, Ding YL. Analgesic effect of iliopsoas plane block for hip fracture. Perioper Med (Lond). 2022 Apr 14;11(1):15. doi: 10.1186/s13741-022-00254-3.
- Nielsen ND, Madsen MN, Ostergaard HK, Bjorn S, Pedersen EM, Nielsen TD, Soballe K, Borglum J, Bendtsen TF. An iliopsoas plane block does not cause motor blockade-A blinded randomized volunteer trial. Acta Anaesthesiol Scand. 2020 Mar;64(3):368-377. doi: 10.1111/aas.13498. Epub 2019 Nov 13.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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 27
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.
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