Iliopsoas Plane Block vs PENG Block for Hip Arthroplasty

NCT ID: NCT05397145

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-31

Study Completion Date

2024-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 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. Pericapsular nerve group block (PENG block) is a novel fascial block defined by Arango et al. This block aims to block the femoral nerve and the accessory obturator nerve by injecting local anesthetic between the pubic ramus and the psoas tendon. 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. This prospective study compares the efficacy of PENG block and IPB for postoperative analgesia management in patients undergoing hip arthroplasty with a prosthesis.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hip Fractures Hip Injuries Hip Arthropathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

There are two models for this study. Iliopsoas plane block (IPB) group, and PENG block group.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The patient and the outcomes assessor who performs postoperative pain evaluation will not know the group.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Postoperative analgesia management

Intervention Type 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. 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.

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.

Group Type ACTIVE_COMPARATOR

Postoperative analgesia management

Intervention Type 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. 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Postoperative analgesia management

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medipol University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Bahadir Ciftci

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istanbul Medipol University Hospital

Istanbul, Bagcilar, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 30063657 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33637625 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35351697 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32447169 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34175637 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35418144 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31650529 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Medipol Hospital 27

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Comparison of QIPB and SIFICB in Hip Surgery
NCT07233746 NOT_YET_RECRUITING NA