PENG Block Plus Lateral Femoral Cutaneous Nerve Block for Posterolateral-approached Total Hip Arthroplasty (PENG-FLAT)

August 29, 2023 updated by: Giuseppe Pascarella, Campus Bio-Medico University

PENG Block Combined to Lateral Femoral Cutaneous Nerve Block vs. PENG Block Combined to Wound Infiltration for Postoperative Analgesia Following Posterolateral-approached Total Hip Arthroplasty

This study aims to analyze the effect of Pericapsular Nerve Group (PENG) Block combined with lateral femoral cutaneous nerve block vs. PENG block combined with wound infiltration for analgesia after elective hip replacement performed with a posters-lateral approach.

Half of participants will receive a PENG Block combined with femoral lateral cutaneous nerve block, while the other half will receive PENG Block combined with wound infiltration

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

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
      • Rome, Italy
        • Campus Bio-medico University Hospital Foundation

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Elective hip replacement surgery performed with a poster-lateral approach
  • ASA physical status score < 4

Exclusion Criteria:

  • Contraindications to regional anesthesia
  • ASA physical status score ≥ 4
  • Patient's refusal or inability to sign the informed consent
  • Allergies to any drug provided by the study protocol

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 plus Femoral Cutaneous Nerve Block
Participants receiving PENG block combined to Lateral Femoral Cutaneous Nerve Block
Procedure: PENG Block
At the end of surgery, in Post Anesthesia Recovery Room (PACU), PENG block with 20 mL of 0.5 % Ropivacaine will be executed as described by Giron-Arango et al. using a low frequency curvilinear probe. A 22G 80 mm needle (Stimuplex Ultra 360, B.Braun) will be used.
Procedure: Lateral Femoral Cutaneous Nerve Block
At the end of surgery, in Post Anesthesia Recovery Room (PACU), ultrasound guided Lateral Femoral Cutaneous Nerve Block will be performed with 10 mL of 0.5 % Ropivacaine using a high frequency linear probe. A 22G 50 mm needle (Stimuplex Ultra 360, B.Braun) will be used.
Active Comparator: PENG block plus Wound Infiltration
Participants receiving PENG block combined to wound infiltration
Procedure: PENG Block
At the end of surgery, in Post Anesthesia Recovery Room (PACU), PENG block with 20 mL of 0.5 % Ropivacaine will be executed as described by Giron-Arango et al. using a low frequency curvilinear probe. A 22G 80 mm needle (Stimuplex Ultra 360, B.Braun) will be used.
Procedure: Wound Infiltration
At the end of operation, the surgeon will perform wound infiltration with 20 mL of 0.5 % Ropivacaine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Static Pain Score
Time Frame: 24 hours
A numerical rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain) will be used to evaluate pain at rest during 24 hours after surgery
24 hours
Dynamic Pain Score
Time Frame: 24 hours
A numerical rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain) will be used to evaluate pain on movement during 24 hours after surgery
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of hip motion
Time Frame: 24 hours
Degrees of hip flexion
24 hours
Quadriceps Strength
Time Frame: 24 hours
Ability to flex the knee against gravity
24 hours
Ability to start physiotherapy during the first postoperative day
Time Frame: 24 hours
YES: the patient was able to start physiotherapy NO: the patient was not able to start physiotherapy during the first postoperative day due to pain or motor block
24 hours
Ability to ambulate with the help of a walker during the first postoperative day
Time Frame: 24 hours
YES: The patient was able to ambulate with the help of a walker NO: The patient was not able to ambulate with the help of a walker due to pain or motor block
24 hours
Incidence of block complications
Time Frame: 24 hours

Any complications or side effects of the blocks, such as local infection, intravascular injection of local anesthetics and immediate systemic toxicity.

Moreover, incidence of nausea, vomiting and postoperative respiratory depression will be recorded
24 hours
Morphine consumption
Time Frame: 24 hours
Total of intravenous morphine (expressed in milligrams) administered during the first 24 hours after surgery
24 hours
Morphine consumption
Time Frame: 6 days
Total of intravenous morphine (expressed in milligrams) administered during the entire hospitalization
6 days
Hospital Length of Stay
Time Frame: 6 days
Total Hospital length of Stay (expressed in days)
6 days

Collaborators and Investigators

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

Sponsor

Campus Bio-Medico University

Investigators

  • Principal Investigator: Giuseppe Pascarella, MD, University Hospital Campus Biomedico of Rome

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

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)

July 1, 2022

Primary Completion (Actual)

May 18, 2023

Study Completion (Actual)

May 25, 2023

Study Registration Dates

First Submitted

June 20, 2022

First Submitted That Met QC Criteria

June 20, 2022

First Posted (Actual)

June 24, 2022

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAR 34.22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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