NCT06677606

Brief Summary

The goal of this intervention study is to compare the analgesic efficacy of pericapsular nerve group (PENG) block versus periarticular anesthetic infiltration (PAI) block in patients undergo hemiarthroplasty after spinal anesthesia . The main questions it aims to answer are: which block has more analgesic efficacy. which block has more motor-sparing analgesia. Researchers will compare optimal motor-sparing analgesia between PENG block and PAI after hemiarthroplasty. Participants will be divided in two groups : group receive PENG block and other group receive PAI

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

November 1, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 6, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

February 20, 2025

Status Verified

February 1, 2025

Enrollment Period

12 months

First QC Date

November 2, 2024

Last Update Submit

February 19, 2025

Conditions

Keywords

PENG bockPAI block

Outcome Measures

Primary Outcomes (1)

  • the pain score (NRS)

    the pain score (NRS) after surgery at rest (score 0 =no pain and 10 =worst pain ever) .

    at 12 hours after injection of local anethesia

Secondary Outcomes (4)

  • the pain score (NRS)

    at 6, 18, 24, and 48 hours after injection of local anethesia

  • Incidence of quadriceps motor block

    at 3,6,24 hours after injection of local anesthesia

  • cumulative morphine consumption in 24 hours.

    at 24 hours after injection of local anethesia

  • The incidence of block-related adverse events (ie, vascular puncture, LA toxicity).

    at 24 hours after injection of local anethesia

Study Arms (2)

PENG block group

EXPERIMENTAL

patients will receive PENG block after skin closure, .Patients will be placed in the supine position. The ultra sound transducer will be placed in a transverse orientation, medial and caudal to the anterosuperior iliac spine in order to identify the anteroinferior iliac spine, the iliopubic eminence and the psoas tendon. Using an in-plane technique and a lateral-to-medial direction, the block needle will be advanced until its tip will be positioned on the periosteum dorsal to the psoas tendon. The LA (20mL of bupivacaine 0.5%) will be injected following negative aspiration.. The accurate position of the needle was confirmed by hydro dissection and spread under the illo-psoas muscle .

Procedure: PENG block

PAI group

ACTIVE COMPARATOR

PIA BLOCK For subjects randomized to PAI , LA infiltration will be carried out using a total dose of 150mg of bupivacaine and a total volume of 60mL. The admixture (consisting of 60mL of bupivacaine 0.25% and 30mg of ketorolac) will be loaded into two 30mL syringes at the beginning of surgery. After insertion of the acetabular component (and before insertion of the femoral stem), the surgeon will infiltrate the deep tissues (ie, anterior and posterior capsules, gluteus minimus and medius muscles, supraacetabular region, area around the anterior inferior iliac spine, and quadratus femoris muscle all the while avoiding the deep hip external rotator muscle group in order to prevent sciatic nerve block) with the first 30mL syringe. Before wound closure, the gluteus maximus muscle, iliotibial band, subcutaneous tissues, and skin will be infiltrated with the second 30mL syringe.

Procedure: PAI block

Interventions

PENG blockPROCEDURE

The ultra sound transducer will be placed in a transverse orientation, medial and caudal to the anterosuperior iliac spine in order to identify the anteroinferior iliac spine, the iliopubic eminence and the psoas tendon. Using an in-plane technique and a lateral-to-medial direction, the block needle will be advanced until its tip will be positioned on the periosteum dorsal to the psoas tendon. The LA (20mL of bupivacaine 0.5%) will be injected following negative aspiration.. The accurate position of the needle was confirmed by hydro dissection and spread under the illo-psoas muscle

PENG block group
PAI blockPROCEDURE

LA infiltration will be carried out using a total dose of 150mg of bupivacaine and a total volume of 60mL. The admixture (consisting of 60mL of bupivacaine 0.25% and 30mg of ketorolac) will be loaded into two 30mL syringes at the beginning of surgery. After insertion of the acetabular component (and before insertion of the femoral stem), the surgeon will infiltrate the deep tissues (ie, anterior and posterior capsules, gluteus minimus and medius muscles, supraacetabular region, area around the anterior inferior iliac spine, and quadratus femoris muscle all the while avoiding the deep hip external rotator muscle group in order to prevent sciatic nerve block) with the first 30mL syringe. Before wound closure, the gluteus maximus muscle, iliotibial band, subcutaneous tissues, and skin will be infiltrated with the second 30mL syringe.

PAI group

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ages from 50 to 90 years and undergoing bipolar hemiarthroplasty in Fayoum university hospital American Society of Anesthesiologists (ASA) physical status I to III,.

You may not qualify if:

  • Patient refusal. contraindication to spinal anesthesia . clinically significant coagulopathy. infection at the injection site. allergy to local anesthetics. body mass index\>35 kg m2., diabetic or other neuropathies. patients receiving opioids for chronic analgesic therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fayoum university hospital

Al Fayyum, 63514, Egypt

RECRUITING

Related Publications (7)

  • Natrajan P, Bhat RR, Remadevi R, Joseph IR, Vijayalakshmi S, Paulose TD. Comparative Study to Evaluate the Effect of Ultrasound-Guided Pericapsular Nerve Group Block Versus Fascia Iliaca Compartment Block on the Postoperative Analgesic Effect in Patients Undergoing Surgeries for Hip Fracture under Spinal Anesthesia. Anesth Essays Res. 2021 Jul-Sep;15(3):285-289. doi: 10.4103/aer.aer_122_21. Epub 2022 Feb 7.

    PMID: 35320956BACKGROUND
  • 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
  • Senthil KS, Kumar P, Ramakrishnan L. Comparison of Pericapsular Nerve Group Block versus Fascia Iliaca Compartment Block as Postoperative Pain Management in Hip Fracture Surgeries. Anesth Essays Res. 2021 Oct-Dec;15(4):352-356. doi: 10.4103/aer.aer_119_21. Epub 2022 Mar 1.

    PMID: 35422548BACKGROUND
  • Aliste J, Layera S, Bravo D, Jara A, Munoz G, Barrientos C, Wulf R, Branez J, Finlayson RJ, Tran Q. Randomized comparison between pericapsular nerve group (PENG) block and suprainguinal fascia iliaca block for total hip arthroplasty. Reg Anesth Pain Med. 2021 Oct;46(10):874-878. doi: 10.1136/rapm-2021-102997. Epub 2021 Jul 20.

    PMID: 34290085BACKGROUND
  • Bravo D, Aliste J, Layera S, Fernandez D, Erpel H, Aguilera G, Arancibia H, Barrientos C, Wulf R, Leon S, Branes J, Finlayson RJ, Tran Q. Randomized clinical trial comparing pericapsular nerve group (PENG) block and periarticular local anesthetic infiltration for total hip arthroplasty. Reg Anesth Pain Med. 2023 Oct;48(10):489-494. doi: 10.1136/rapm-2023-104332. Epub 2023 Feb 16.

    PMID: 36797036BACKGROUND
  • Ye S, Wang L, Wang Q, Li Q, Alqwbani M, Kang P. Comparison between Ultrasound-Guided Pericapsular Nerve Group Block and Local Infiltration Analgesia for Postoperative Analgesia after Total Hip Arthroplasty: A Prospective Randomized Controlled Trial. Orthop Surg. 2023 Jul;15(7):1839-1846. doi: 10.1111/os.13777. Epub 2023 Jun 29.

    PMID: 37382431BACKGROUND
  • Hu J, Wang Q, Hu J, Kang P, Yang J. Efficacy of Ultrasound-Guided Pericapsular Nerve Group (PENG) Block Combined With Local Infiltration Analgesia on Postoperative Pain After Total Hip Arthroplasty: A Prospective, Double-Blind, Randomized Controlled Trial. J Arthroplasty. 2023 Jun;38(6):1096-1103. doi: 10.1016/j.arth.2022.12.023. Epub 2022 Dec 16.

    PMID: 36529195BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Mohamed A Hamed, MD

    Faculty of medicine, Fayoum university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

mohamed I kamaleldeen, Bch

CONTACT

yasser s mostafa, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesiology

Study Record Dates

First Submitted

November 2, 2024

First Posted

November 6, 2024

Study Start

November 1, 2024

Primary Completion

October 31, 2025

Study Completion

October 31, 2025

Last Updated

February 20, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations