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Iliopsoas Plane Block vs PENG Block for Hip Arthroplasty

Primary Purpose

Hip Fractures, Hip Injuries, Hip Arthropathy

Status
Recruiting
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, Postoperative pain management, PENG block, Iliopsoas plane block

Eligibility Criteria

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

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

Sites / Locations

  • Istanbul Medipol University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group IPB = Iliopsoas plane block

Group PENG = PENG block

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Opioid consumption
The fentanyl consumption on PCA device will be evaluated

Secondary Outcome Measures

Pain scores (Numerical Rating Scale-NRS)
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
Quadriceps muscle strength
Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the Oxford muscle strength rating

Full Information

First Posted
May 25, 2022
Last Updated
February 16, 2023
Sponsor
Medipol University
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1. Study Identification

Unique Protocol Identification Number
NCT05397145
Brief Title
Iliopsoas Plane Block vs PENG Block for Hip Arthroplasty
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

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 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
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.

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, Postoperative pain management, PENG block, Iliopsoas plane block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There are two models for this study. Iliopsoas plane block (IPB) group, and 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
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group IPB = Iliopsoas plane block
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group PENG = PENG block
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, 20 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. 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.
Primary Outcome Measure Information:
Title
Opioid consumption
Description
The fentanyl consumption on PCA device will be evaluated
Time Frame
Changes from baseline opioid consumption at postoperative 0, 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 NRS score (0 = no pain, 10 = the most severe pain felt)
Time Frame
Changes from baseline pain scores at postoperative 0, 2, 4, 8, 16 and 24 hours
Title
Quadriceps muscle strength
Description
Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the Oxford muscle strength rating
Time Frame
Postoperative 24 hours period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bahadir Ciftci, Assoc prof, MD
Phone
+905343736865
Email
bciftci@medipol.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Yunus Atalay, Assoc prof, MD
Facility Information:
Facility Name
Istanbul Medipol University Hospital
City
Istanbul
State/Province
Bagcilar
ZIP/Postal Code
34070
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bahadir Ciftci, MD
Phone
+905325034428
Email
bciftci@medipol.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The investigators will not share IPD
Citations:
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
33637625
Citation
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.
Results Reference
background
PubMed Identifier
35351697
Citation
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.
Results Reference
background
PubMed Identifier
32447169
Citation
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.
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
PubMed Identifier
35418144
Citation
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.
Results Reference
background
PubMed Identifier
31650529
Citation
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.
Results Reference
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Iliopsoas Plane Block vs PENG Block for Hip Arthroplasty

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