NCT05397145

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

May 31, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2.3 years

First QC Date

May 25, 2022

Last Update Submit

September 16, 2024

Conditions

Keywords

Hip arthroplastyPostoperative pain managementPENG blockIliopsoas plane block

Outcome Measures

Primary Outcomes (1)

  • Opioid consumption

    The fentanyl consumption on PCA device will be evaluated

    Changes from baseline opioid consumption at postoperative 0, 2, 4, 8, 16 and 24 hours.

Secondary Outcomes (2)

  • Pain scores (Numerical Rating Scale-NRS)

    Changes from baseline pain scores at postoperative 0, 2, 4, 8, 16 and 24 hours

  • Quadriceps muscle strength

    Postoperative 24 hours period

Study Arms (2)

Group IPB = Iliopsoas plane block

ACTIVE COMPARATOR

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.

Other: Postoperative analgesia management

Group PENG = PENG block

ACTIVE COMPARATOR

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.

Other: Postoperative analgesia management

Interventions

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 IPB = Iliopsoas plane blockGroup PENG = PENG block

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with ASA classification I-III,
  • Aged 20-80 years
  • Who will be scheduled for hip arthroplasty under general anesthesia.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University Hospital

Istanbul, Bagcilar, 34070, Turkey (Türkiye)

Location

Related Publications (7)

  • 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.

    PMID: 30063657BACKGROUND
  • 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.

    PMID: 33637625BACKGROUND
  • 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.

    PMID: 35351697BACKGROUND
  • 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.

    PMID: 32447169BACKGROUND
  • 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.

    PMID: 34175637BACKGROUND
  • 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.

    PMID: 35418144BACKGROUND
  • 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.

    PMID: 31650529BACKGROUND

MeSH Terms

Conditions

Hip FracturesHip Injuries

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesLeg Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The patient and the outcomes assessor who performs postoperative pain evaluation will not know the group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: There are two models for this study. Iliopsoas plane block (IPB) group, and PENG block group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 25, 2022

First Posted

May 31, 2022

Study Start

May 31, 2022

Primary Completion

August 30, 2024

Study Completion

August 30, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

The investigators will not share IPD

Locations