Combined PENG and LFCN Block for Total Hip Arthroplasty

August 6, 2021 updated by: Lennert De Schrijver, University Hospital, Antwerp

Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Block for Total Hip Arthroplasty: A Randomized Controlled Trial

A clinical trial investigating the effect of a combined locoregional anesthesia technique on the postoperative analgesia outcomes after a total hip arthroplasty. A PENG block will be used in combination with a LFCN block. The results will be compared to a control group that is solely treated with intravenous analgesia. This technique aims to provide improved pain scores after surgery without interference of revalidation.

Study Overview

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

      • Deurne, Belgium
        • AZ Monica

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 to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult patients who underwent a primary total hip replacement under general anesthesia

Exclusion Criteria:

  • insulin dependent diabetes mellitus
  • chronic pain
  • severe dementia or mental retardation
  • allergy to local anesthetics

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
Active Comparator: PENG + LFCN block

The participants in this group received a combined regional technique just before surgery:

  • Pericapsular nerve group (PENG) block
  • Lateral femoral cutaneus nerve (LFCN) block
Regional anesthesia technique
Other Names:
  • pericapsular nerve group block
  • lateral femoral cutaneous nerve block
Local anesthetic used for peripheral nerve block.
Other Names:
  • ropivacaine 0.375%
No Intervention: No regional anesthesia
Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Initial pain score
Time Frame: 0 hours postoperative
numeric rating score (NRS) of 0 to 10
0 hours postoperative
Pain score after 2h
Time Frame: 2 hours postoperative
numeric rating score (NRS) of 0 to 10
2 hours postoperative
Pain score after 24h
Time Frame: 24 hours postoperative
numeric rating score (NRS) of 0 to 10
24 hours postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Initial motor function
Time Frame: 0 hours postoperative
score chart inspired by the Bromage score (NRS) of 0 to 3
0 hours postoperative
Motor function after 2h
Time Frame: 2 hours postoperative
score chart inspired by the Bromage score (NRS) of 0 to 3
2 hours postoperative
Motor function after 24h
Time Frame: 24 hours postoperative
score chart inspired by the Bromage score (NRS) of 0 to 3
24 hours postoperative
Intraoperative opioids
Time Frame: intraoperative
dose of intravenous opioids in microgram per kilogram bodyweight
intraoperative
Postoperative opioids
Time Frame: 24 hours postoperative
dose of intravenous opioids in microgram per kilogram bodyweight
24 hours postoperative

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Yzabel Vandevivere, MD, AZ Monica

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)

June 1, 2020

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

October 1, 2020

Study Registration Dates

First Submitted

July 19, 2021

First Submitted That Met QC Criteria

August 6, 2021

First Posted (Actual)

August 9, 2021

Study Record Updates

Last Update Posted (Actual)

August 9, 2021

Last Update Submitted That Met QC Criteria

August 6, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

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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