The Pericapsular Nerve Block in Total Hip Arthroplasty

Study Overview
=================
Brief 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.

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.

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

Conditions
-----------------
Hip Osteoarthritis, Hip Arthropathy

Intervention / Treatment
-----------------
* Other: Pericapsular Nerve Block
* Other: Fascia Iliaca Nerve Block


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pericapsular Nerve Block Group<br>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<br>* Per Standard Institutional Practice<br>|
| Active Comparator: Fascia Iliaca Nerve Block Group<br>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<br>* Per Standard Institutional Practice<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Total Hip Arthroplasty, Total Hip Replacement, Hip Arthroplasty, Hip Replacement, Postoperative Pain