PENG Block vs FNB + ONB in Patients Undergoing Hip Fracture Surgery With Contraindications to Neuraxial Anesthesia (PENG/FNB+ONB)

June 13, 2024 updated by: Francesca Gargano, Campus Bio-Medico University

Pericapsular Nerve Group (PENG) Block vs Femoral Nerve Block (FNB) + Obturator Nerve Block (ONB) in Patients Undergoing Hip Fracture Surgery With Contraindications to Neuraxial Anesthesia

The aim of the study is to demonstrate the efficacy of PENG block as the main anesthetic technique to manage perioperative analgesia for hip fracture surgery compared to femoral and obturator nerve block in patients with contraindications to spinal anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

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.

Study Locations

  • Italy
      • Roma, Italy, 00128
        • Campus Bio Medico

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients undergo hip surgery
  • patients with contraindications at spinal anesthesia

Exclusion Criteria:

  • allergy at local anesthetic
  • age under 18 or weight under 30

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PENG block
Before surgery, Patients undergo to ultrasound guided PENG block administering ropivacaine 0.5 % 20 mL.
Procedure: PENG BLOCK
Preoperative ultrasound guided PENG block (ropivacaine 0.5 % 20 mL)
Active Comparator: Femoral nerve block + Obturator nerve block
Before surgery, Patients undergo to ultrasound guided femoral nerve block (ropivacaine 0.5 % 15 mL) + obturator nerve block (ropivacaine 0.5% 5 mL).
Procedure: Femoral Nerve Block
Preoperative ultrasound guided femoral nerve block (ropivacaine 0.5 % 15 mL)
Procedure: Obturator Nerve Block
Preoperative ultrasound guided obturator nerve block (ropivacaine 0.5 % 5 mL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
preoperative pain
Time Frame: 30 minutes
Preoperative pain score expressed by numerical rating scale 0-10
30 minutes
Pain following regional anesthesia
Time Frame: 30 minutes
Preoperative pain score following regional anesthesia execution expressed by numerical rating scale 0-10
30 minutes
Postoperative pain
Time Frame: 24 hours
Postoperative pain score expressed by a numerical rating scale 0-10
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphine milligrams (mg) consumption
Time Frame: 24 hours
needed opioid rescue therapy
24 hours

Collaborators and Investigators

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

Sponsor

Campus Bio-Medico University

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)

January 1, 2022

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

June 1, 2024

Study Registration Dates

First Submitted

June 10, 2024

First Submitted That Met QC Criteria

June 10, 2024

First Posted (Actual)

June 13, 2024

Study Record Updates

Last Update Posted (Actual)

June 14, 2024

Last Update Submitted That Met QC Criteria

June 13, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Campus Bio-Medico

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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