Comparison of PENG Block and Fascia Iliaca Compartment Block in the Postoperative Pain Control of Hip Capsular Fracture

March 16, 2023 updated by: Carles Espinos Ramírez, Consorci Sanitari de Terrassa
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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Hip fractures are a very common clinical situation in elderly patients and are associated with significant morbidity and mortality. In addition, they have a great social and economic impact that in most cases requires definitive surgical treatment.

Although it is a very common procedure, in proximal femur surgery there is great variability with respect to anesthetic procedures and their subsequent management. Subarachnoid anesthesia is the most commonly used for this type of surgery. During the last few years, different locoregional techniques have been described with the aim of improving perioperative analgesia in these patients. Some examples are the iliac fascia block, the 3-in-1 block or the femoral nerve block, which allow a lower consumption of opioids and reduce some adverse effects such as postoperative delirium.

The PENG (Pericapsular Nerve Group) block is a block recently described for pain management in proximal femoral surgery. It is a pure sensory block that was initially described as an analgesic technique for the treatment of acute pain after femoral fracture but has expanded its uses. Its target corresponds precisely to the described innervation of the anterior femoral capsule.

Regarding the other locoregional techniques mentioned above, these consist of non-selective blocks of the femoral, lateral femoral cutaneous and obturator nerves. Therefore, although the iliac fascia block is accepted for analgesic control of hip fracture, the PENG block is likely to be more effective because of its high selectivity.

For this reason, the investigators have decided to conduct 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.

Study Type

Observational

Enrollment (Anticipated)

88

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Carles Espinós Ramírez
  • Phone Number: +34650125113
  • Email: md071683@uic.es

Study Locations

    • Barcelona
      • Terrassa, Barcelona, Spain, 8227
        • Recruiting
        • Consorci Sanitari de Terrassa
        • Contact:
          • Carles Espinós Ramírez
          • Phone Number: +34 650125113
          • Email: md071683@uic.es

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Definitive 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.
Definitive surgical treatment of femur fracture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-surgical pain after the disappearance of the motor block
Time Frame: Approximately from 1 to 2 hours after de surgery, when the effect of the spinal anesthesia disappears.
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
Time Frame: 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
Time Frame: 24 hours after surgery
24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

May 9, 2022

First Submitted That Met QC Criteria

May 15, 2022

First Posted (Actual)

May 17, 2022

Study Record Updates

Last Update Posted (Actual)

March 17, 2023

Last Update Submitted That Met QC Criteria

March 16, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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