NCT05377541

Brief Summary

A prospective cohort study comparing PENG block versus iliac fascia block with the aim of evaluating its effectiveness in the peri-surgical analgesia of intracapsular femoral fracture.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

April 29, 2022

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 17, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 17, 2023

Status Verified

March 1, 2023

Enrollment Period

1.6 years

First QC Date

May 9, 2022

Last Update Submit

March 16, 2023

Conditions

Keywords

subcapitalhip fracturePENGFascia iliaca compartment blockPostoperative pain

Outcome Measures

Primary Outcomes (3)

  • Post-surgical pain after the disappearance of the motor block

    Pain will be assessed through the Verbal Numerical Scale (VNS). The VNS is a numeric scale with a minimum value of 0 and a maximum of 10 where 0 means no pain and 10 maximum pain.

    Approximately from 1 to 2 hours after de surgery, when the effect of the spinal anesthesia disappears.

  • Pain 24 hours after surgery

    Pain will be assessed through the Verbal Numerical Scale (VNS). The VNS is a numeric scale with a minimum value of 0 and a maximum of 10 where 0 means no pain and 10 maximum pain.

    24 hours after surgery

  • Need for rescue analgesia

    24 hours after surgery

Study Arms (2)

PENG block

To perform the PENG block, the patient will be placed in the supine position and with the convex transducer in a transverse plane over the anteroinferior iliac spine, the probe will be aligned with the iliopectineal eminence of the pubic ramus rotating about 45º medially.

Procedure: Surgical treatment of femur fracture

Fascia iliaca compartment block

To perform the iliac fascia block, the patient is placed in the supine position and with the linear transducer placed at the junction of the middle third with the lateral third of the inguinal ligament, the needle is inserted through the fascia lata and the iliac fascia.

Procedure: Surgical treatment of femur fracture

Interventions

Definitive surgical treatment of femur fracture.

Fascia iliaca compartment blockPENG block

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Population admitted to the hospital and scheduled for definitive surgical treatment of femur fracture.

You may qualify if:

  • Patients with subcapital, basicervical or transcervical femoral fracture in whom definitive surgical treatment is decided.
  • Patients who are candidates for nerve block plus intradural anesthesia.
  • Patients who agree to participate in the study

You may not qualify if:

  • Patients with dementia or cognitive impairment (EVN not evaluable)
  • Polytraumatized patient
  • Patient's refusal to participate in the study
  • Patient's refusal to undergo intradural anesthesia or the blockade
  • Patient with sensory or motor deficits prior to surgery.
  • Patient with anticoagulation or antiplatelet therapy at the time of surgery.
  • Hemodynamically unstable patient or patient who becomes unstable during surgery.
  • Patient allergic to the local anesthetic.
  • Patient with chronic pain in treatment
  • Patient with capital femur fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Consorci Sanitari de Terrassa

Terrassa, Barcelona, 8227, Spain

RECRUITING

Related Publications (6)

  • Allard C, Pardo E, de la Jonquiere C, Wyniecki A, Soulier A, Faddoul A, Tsai ES, Bonnet F, Verdonk F. Comparison between femoral block and PENG block in femoral neck fractures: A cohort study. PLoS One. 2021 Jun 4;16(6):e0252716. doi: 10.1371/journal.pone.0252716. eCollection 2021.

    PMID: 34086782BACKGROUND
  • Jadon A, Mohsin K, Sahoo RK, Chakraborty S, Sinha N, Bakshi A. Comparison of supra-inguinal fascia iliaca versus pericapsular nerve block for ease of positioning during spinal anaesthesia: A randomised double-blinded trial. Indian J Anaesth. 2021 Aug;65(8):572-578. doi: 10.4103/ija.ija_417_21. Epub 2021 Aug 25.

    PMID: 34584279BACKGROUND
  • Acharya U, Lamsal R. Pericapsular Nerve Group Block: An Excellent Option for Analgesia for Positional Pain in Hip Fractures. Case Rep Anesthesiol. 2020 Mar 12;2020:1830136. doi: 10.1155/2020/1830136. eCollection 2020.

    PMID: 32231802BACKGROUND
  • Ueshima H, Otake H. RETRACTED: Clinical experiences of pericapsular nerve group (PENG) block for hip surgery. J Clin Anesth. 2018 Dec;51:60-61. doi: 10.1016/j.jclinane.2018.08.003. Epub 2018 Aug 8. No abstract available.

    PMID: 30096522BACKGROUND
  • Sahoo RK, Jadon A, Sharma SK, Peng PW. Peri-capsular nerve group block provides excellent analgesia in hip fractures and positioning for spinal anaesthesia: A prospective cohort study. Indian J Anaesth. 2020 Oct;64(10):898-900. doi: 10.4103/ija.IJA_450_20. Epub 2020 Oct 1. No abstract available.

    PMID: 33437080BACKGROUND
  • Esteller PG, Ramirez CE, Juarez-Pomes M, Martin Sanchez JC, Martinez Garcia M. PENG Block: A superior alternative for pain management in intracapsular hip fractures. Saudi J Anaesth. 2025 Apr-Jun;19(2):251-256. doi: 10.4103/sja.sja_96_25. Epub 2025 Mar 25.

MeSH Terms

Conditions

Hip FracturesPain, Postoperative

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Carles Espinós Ramírez

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 9, 2022

First Posted

May 17, 2022

Study Start

April 29, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

March 17, 2023

Record last verified: 2023-03

Locations