PENG Block Versus Fascia Iliaca Block for Pre- and Post-Operative Analgesia in Elderly Patients With Hip Fracture

September 27, 2020 updated by: Khaled Moustafa Magdy Nasr Mohamed, Zagazig University

Pericapsular Nerve Group Block Versus Fascia Iliaca Block for Pre- and Post-Operative Analgesia in Elderly Patients With Hip Fracture

Clinical controled trial to compare between pericapsular Nerve Group Block and Fascia Iliaca Block to find the best way to provide analgesia for elderly patients with hip fracture in the pre- and post-operative periods.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Pain is a major problem that has to be dealt with in case of hip fracture, as it resembles an obstacle for examination, positioning for receiving neuroaxial anesthesia and postoperative mobility and physiotherapy.

With the introduction of ultrasound in regional anesthesia and peripheral nerve blocks, regional analgesia float to the surface as a substitute for opioids with less side effects. Of the many techniques to provide regional analgesia for hip fractures; fascia iliaca block was widely used with good results. In 2018 Pericapsular Nerve Group Block was introduced to provide regional analgesia for hip fractures with interesting results.

In this study the investigators are going to compare Pericapsular Nerve Group Block and Fascia Iliaca Block to find the best way to provide analgesia for elderly patients with hip fracture in the pre- and post-operative periods.

Study Type

Interventional

Enrollment (Anticipated)

51

Phase

  • Not Applicable

Contacts and Locations

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

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient acceptance.
  2. Accepted mental state of the patient.
  3. Gender: both sexes.
  4. Age above 65 years old.
  5. Body mass index 18.5-35 kg/m2.
  6. ASA physical status II and III.
  7. Unilateral hip fracture assigned for surgical fixation.
  8. Expected duration of surgery ≤ 3 hours.

Exclusion Criteria:

  1. Associated trauma or multiple fractures.
  2. Peripheral neuropathy.
  3. Coagulopathy.
  4. Infection at site of injection.
  5. Allergy to the drugs used in the study.
  6. Advanced kidney, liver or heart disease.

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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group C
Patients will be assigned to receive opioids analgesia before spinal anesthesia in the form of intravenous fentanyl in a dose of 1mic/kg divided into two boluses with 5 minutes interval in between before positioning the patient for spinal anesthesia.
Drug: Fentanyl
Intravenous fentanyl in a dose of 1mic/kg divided into two boluses with 5 minutes interval in between.
Other Names:
  • Intravenous opioid
Experimental: Group P
Patients will be assigned to receive Pericapsular Nerve Group Block (PENG Block) before positioning the patient for spinal anesthesia.
Procedure: Pericapsular nerve Group block
Under ultrasound guidance a needle is inserted between the iliopectineal eminence and the iliopsoas muscle and tendon to block articular branches supplying the capsule of hip joint.
Other Names:
  • PENG block
Experimental: Group F
Patients will be assigned to receive Fascia Iliaca Block (F.I Block) before positioning for spinal anesthesia.
Procedure: Facia Iliaca block
Under ultrasound guidance a needle is inserted between the fascia iliaca and Psoas muscle to block the femoral, obturator and lateral cutaneous nerves.
Other Names:
  • FI block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison between the analgesic effect of both Pericapsular Nerve Group block and Fascia Iliaca block with VAS score.
Time Frame: Baseline
Analysis of Visual Analogue Pain Score for both PENG block and FI block before and after each block during rest and movement to compare between their analgesic effect. The Visual Analogue Pain score is done by drawing a 10cm vertical line on a piece of paper with its limits "no pain" (0) on one side and "extreme pain" (10) on the other side. The patient will be asked to point where the pain (he/she) experiences lies on the line.
Baseline

Collaborators and Investigators

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

Sponsor

Zagazig University

Investigators

  • Principal Investigator: Khaled M Mohamed, Master degree, Zagazig University

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.

General Publications

Helpful Links

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 (Anticipated)

January 1, 2021

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

September 20, 2020

First Submitted That Met QC Criteria

September 20, 2020

First Posted (Actual)

September 25, 2020

Study Record Updates

Last Update Posted (Actual)

September 30, 2020

Last Update Submitted That Met QC Criteria

September 27, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6228/20-7-2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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