Analgesic Comparison of PENG/LFCN to FICB for Total Hip Arthroplasty (PengvsFICB)

July 28, 2022 updated by: Patrick Myer, SSM Health Bone and Joint Hospital at St Anthony

Analgesic Comparison of Pericapsular Nerve Group (PENG) Block and Lateral Femoral Cutaneous Nerve (LFCN) Block to Fascia Iliaca Compartment Block (FICB) in Patients Undergoing Primary Total Hip Arthroplasty (THA).

This study compares 2 commonly used interventions (regional pain blocks) used in hip arthroplasty for pain control. One of the interventions is newer and not widely established.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will compare the FICB to the PENG/LFCN blocks. Patient reported pain scores on a verbal numeric rating scale will be utilized and recorded in the PACU and postoperatively at 3, 6, 12, 18, 24, 36 and 48 hours after patient arrival in the PACU. Additionally, opioid consumption will be converted to morphine milliequivalents and compared between groups.

Study Type

Interventional

Enrollment (Anticipated)

105

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

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Recruiting
        • SSM Healthcare Bone and Joint Hosptial at St Anthony
        • Contact:

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

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Eligibility criteria for the study were: age 40-80, Physical Status I-III, BMI less than 40 kg/m2, ability to read and speak English, able to sign their own consent form and undergoing elective primary total hip arthroplasty.

Exclusion Criteria:

  • Patients were excluded if they were chronically prescribed opioids for a condition unrelated to their surgical hip pain, were deemed Physical Status 4 or higher, had an ongoing coagulopathy, had any infection near the site of injection, had an allergy to local anesthetics, deemed to have diabetic neuropathy, deemed to have a contraindication to spinal anesthesia or were unable to report their pain scores reliably (as in severe dementia or similar).

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: pericapsular nerve group block and lateral femoral cutaneous nerve block
Nerve blocks
Procedure: Pericapsular Nerve Group Block with Lateral Femoral Cutaneous Nerve Block
Local anesthetic will be deposited along the lower pelvis to block 3 nerves that innervate the anterior hip capsule
Procedure: Fascia Iliaca Compartment Block
Local anesthetic is deposited between the fascia iliaca and the internal oblique muscle in an attempt to block 3 nerves that innervate the hip.
Other Names:
  • Suprainguinal Fascia Iliaca Block
ACTIVE_COMPARATOR: fascia iliaca compartment block
Nerve block
Procedure: Pericapsular Nerve Group Block with Lateral Femoral Cutaneous Nerve Block
Local anesthetic will be deposited along the lower pelvis to block 3 nerves that innervate the anterior hip capsule
Procedure: Fascia Iliaca Compartment Block
Local anesthetic is deposited between the fascia iliaca and the internal oblique muscle in an attempt to block 3 nerves that innervate the hip.
Other Names:
  • Suprainguinal Fascia Iliaca Block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Verbal Numeric Pain Score Comparison of Pericapsular Nerve Group (PENG) Block and Lateral Femoral Cutaneous Nerve (LFCN) Block to Fascia Iliaca Compartment Block (FICB) in Patients Undergoing Primary Total Hip Arthroplasty (THA).
Time Frame: 1 year
Patient reported pain scores will be monitored and tracked and compared.
1 year

Collaborators and Investigators

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

Sponsor

SSM Health Bone and Joint Hospital at St Anthony

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 28, 2022

Primary Completion (ANTICIPATED)

February 1, 2023

Study Completion (ANTICIPATED)

February 1, 2023

Study Registration Dates

First Submitted

January 27, 2022

First Submitted That Met QC Criteria

July 25, 2022

First Posted (ACTUAL)

July 28, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 1, 2022

Last Update Submitted That Met QC Criteria

July 28, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • Pro00060032

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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