The Pericapsular Nerve Block in Total Hip Arthroplasty

Hip Osteoarthritis Clinical Trial

— PENG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04729686
• Other study ID #: 1665162
• Status: Recruiting
• Phase: N/A
• Start date: December 9, 2020
• Est. completion date: December 2023

Study information

• Verified date: April 2022
• Source: LifeBridge Health
• Contact: Martin Gesheff
• Phone: 410-601-9467
• Email: mgesheff[@]lifebridgehealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hip Arthropathy
• Hip Osteoarthritis
• Osteoarthritis, Hip

Intervention

Other:
• Pericapsular Nerve Block
Per Standard Institutional Practice
• Fascia Iliaca Nerve Block
Per Standard Institutional Practice

Locations

Country	Name	City	State
United States	Sinai Hospital of Baltimore	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
LifeBridge Health	Rubin Institute for Advanced Orthopedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Time to first opioid medication		End of surgery 48 hours post-operation or discharge
Secondary	Time to first ambulation		End of surgery to 48 hours post-operation or discharge
Secondary	Distance upon first ambulation		48 hours postoperative or discharge
Secondary	Incidence of weakness and falls		End of surgery to 48 hours post-operation or discharge
Secondary	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
Secondary	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