The Pericapsular Nerve Block in Total Hip Arthroplasty (PENG)

The Pericapsular Nerve Block in Total Hip Arthroplasty: A Randomized, Controlled Trial

In order to continue progressing towards outpatient total hip arthroplasty (THA), methods to adequately manage postoperative pain is of paramount importance. The purpose of this study is to quantify the effectiveness of the pericapsular nerve block in total hip arthroplasty in comparison to the fascia iliaca nerve block.

Study Overview

• Status: Recruiting
• Conditions: Hip Osteoarthritis; Hip Arthropathy
• Intervention / Treatment: Other: Pericapsular Nerve Block; Other: Fascia Iliaca Nerve Block

Detailed Description

This is a single center, randomized, controlled trial in adult subjects undergoing total hip arthroplasty that will receive one of two different nerve block regimens for pain management as part of standard of care.

Effective pain control after surgery for total hip replacement is a critical element in patient recovery. Particularly, in the first few days, as majority of patients may experience significant pain. Improved pain management after surgery contributes to better healing, faster patient mobility, shortened hospital stays, and reduced healthcare costs. While pain management is an important factor in total hip replacement, pain after surgery has yet to be improved. Inadequate pain control can lead to delayed movement, thereby increasing the risk for complications such as blood clots in the legs (deep venous thrombosis - blood clots in your veins) with some patients developing blood clots in their lungs (pulmonary embolus). In addition to pain medications after surgery, nerve blocks such as the femoral or fascia iliaca, have been used as supporting therapy for pain management after a total hip replacement. While these nerve blocks are used on a regular basis, they do have limitations which can produce inconsistent results for pain control and use of pain medications after surgery. With no clear superior nerve block for total hip replacement, a new nerve block, called the pericapsular nerve group (PENG) block has emerged. It has demonstrated the ability to prolong pain relief and decrease the use of pain medications after surgery. Therefore, a randomized study comparing the PENG block to other blocks established within the anesthesia community (e.g., fascia iliaca block) will allow for providers to understand the capabilities this block has in the setting of a total hip replacement.

In addition to your normal standard clinical care, there will scheduled pre-operative, operative, 2-week, and 4-6 week follow-up visits.

• Study Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martin Gesheff; Phone Number: 410-601-9467; Email: mgesheff@lifebridgehealth.org
• Study Contact Backup: Name: Nirav Patel; Email: nirpatel@lifebridgehealth.org

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Recruiting
      • Sinai Hospital of Baltimore
      • Contact: Nirav Patel; Email: nirpatel@lifebridgehealth.org
      • Principal Investigator: Ronald Delanois, MD
      • Sub-Investigator: Ethan Remily, DO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Planned primary total hip arthroplasty with anterior (Smith-Peterson) approach
• ASA score of 1 to 3
• Indicated for one of the two nerve block groups
• Must be opioid naïve at screening as defined by the FDA - According to the Food and Drug Administration, opioid-tolerant patients were those currently receiving or who had previously received 60 mg PO morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg PO oxycodone per day, 8 mg PO hydromorphone per day, 25 mg PO oxymorphone per day, 60 mg PO hydrocodone per day, or an equivalent dose of another opioid for a duration of one week or longer (16)

Exclusion Criteria:

• Current or previous diagnosis of "chronic pain"
• Opioid tolerant at time of screening (for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid.)
• Diagnosis of ankylosing spondylitis
• Allergy to any potential medications utilized in any of the two groups
• Conversion of patient to general anesthesia intraoperatively
• Treatment with another investigational drug or other intervention for pain
• Any condition(s) or diagnosis, both physical or psychological, or physical exam finding in the opinion of the investigator that would precludes participation

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pericapsular Nerve Block Group; Pericapsular Nerve Block targets the anterior hip capsule by blocking the articular branches of the femoral nerve and accessory obturator nerve.	Other: Pericapsular Nerve Block; Per Standard Institutional Practice
Active Comparator: Fascia Iliaca Nerve Block Group; Fascia Iliaca Nerve Block targets the space between the iliacus muscle and the fascia that overlies it (fascia iliaca), within which the femoral nerve and lateral femoral cutaneous nerve (LFCN) course.	Other: Fascia Iliaca Nerve Block; Per Standard Institutional Practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Visual Analog Pain Scale (VAS) Score	Score recorded by drawing a vertical line on a 100 mm horizontal line between "No Pain" (0 mm) and "Worst Pain" (100 mm)	Every 4 hours from end of surgery to 48 hours post surgery or discharge
Postoperative Opioid Consumption in mg	Total opioid consumption will be recorded during postoperative period and at 1 month follow-up visit	Surgery to 1 month post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first opioid medication		End of surgery 48 hours post-operation or discharge
Time to first ambulation		End of surgery to 48 hours post-operation or discharge
Distance upon first ambulation		48 hours postoperative or discharge
Incidence of weakness and falls		End of surgery to 48 hours post-operation or discharge
Harris Hip Score	10 question items measuring pain severity, function, absence of deformity, and range of motion. Scores range from 0-100 with higher scores representing better outcomes.	Last preoperative visit to four weeks post-operation
12 Item Short Form Health Survey Version 2	12 question items measuring health and well being as reported by the patient. 2 scores are calculated: 1) Physical Component Summary Score (PCS) and (2) Mental Health Component Summary Score (MCS) in which scores range from 0-100 with a score of zero indicating lowest level of health and 100 indicating the highest level of health.	Last preoperative visit to four weeks post-operation

Collaborators and Investigators

• Sponsor: LifeBridge Health
• Collaborators: Rubin Institute for Advanced Orthopedics
• Investigators: Principal Investigator: Ronald Delanois, MD, Lifebridge Health

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2020
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: December 22, 2020
• First Submitted That Met QC Criteria: January 27, 2021
• First Posted (Actual): January 28, 2021

Study Record Updates

• Last Update Posted (Actual): April 18, 2022
• Last Update Submitted That Met QC Criteria: April 14, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Postoperative Pain; Hip Arthroplasty; Hip Replacement; Total Hip Arthroplasty; Total Hip Replacement
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: 1665162

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No