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

Sponsor
SSM Health Bone and Joint Hospital at St Anthony (Other)
Overall Status
Recruiting
CT.gov ID
NCT05477641
Collaborator
(none)
105
Enrollment
1
Location
2
Arms
6.2
Anticipated Duration (Months)
17
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Pericapsular Nerve Group Block with Lateral Femoral Cutaneous Nerve Block
  • Procedure: Fascia Iliaca Compartment Block
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
105 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized, single-blinded, controlled studyRandomized, single-blinded, controlled study
Masking:
Single (Participant)
Masking Description:
Patient will be randomized into one of the 2 groups, but will not know which group. Also, the insertion site for both techniques is similar, so they won't be able to tell which group form that evidence either.
Primary Purpose:
Treatment
Official Title:
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).
Actual Study Start Date :
Jul 28, 2022
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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). [1 year]

      Patient reported pain scores will be monitored and tracked and compared.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 SSM Healthcare Bone and Joint Hosptial at St Anthony Oklahoma City Oklahoma United States 73103

    Sponsors and Collaborators

    • SSM Health Bone and Joint Hospital at St Anthony

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Patrick Myer, Chief CRNA SSM Bone and Joint Hospital, SSM Health Bone and Joint Hospital at St Anthony
    ClinicalTrials.gov Identifier:
    NCT05477641
    Other Study ID Numbers:
    • Pro00060032
    First Posted:
    Jul 28, 2022
    Last Update Posted:
    Aug 1, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Aug 1, 2022