The Pericapsular Nerve Block in Total Hip Arthroplasty
- Conditions
- Hip OsteoarthritisHip Arthropathy
- Interventions
- Drug: Pericapsular Nerve BlockDrug: Fascia Iliaca Nerve Block
- Registration Number
- NCT04729686
- Lead Sponsor
- LifeBridge Health
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 78
- 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)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pericapsular Nerve Block Group Pericapsular Nerve Block Pericapsular Nerve Block targets the anterior hip capsule by blocking the articular branches of the femoral nerve and accessory obturator nerve. Fascia Iliaca Nerve Block Group Fascia Iliaca Nerve Block 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. Fascia Iliaca Nerve Block Group Fascia Iliaca Nerve Block 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. Pericapsular Nerve Block Group Pericapsular Nerve Block Pericapsular Nerve Block targets the anterior hip capsule by blocking the articular branches of the femoral nerve and accessory obturator nerve.
- Primary Outcome Measures
Name Time Method Postoperative Opioid Consumption in mg Surgery to 1 month post surgery Total opioid consumption will be recorded during postoperative period and at 1 month follow-up visit
Change in Visual Analog Pain Scale (VAS) Score Every 4 hours from end of surgery to 48 hours post surgery or discharge Score recorded by drawing a vertical line on a 100 mm horizontal line between "No Pain" (0 mm) and "Worst Pain" (100 mm)
- Secondary Outcome Measures
Name Time Method Time to first ambulation End of surgery to 48 hours post-operation or discharge Incidence of weakness and falls End of surgery to 48 hours post-operation or discharge Harris Hip Score Last preoperative visit to four weeks post-operation 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.
Distance upon first ambulation 48 hours postoperative or discharge Time to first opioid medication End of surgery 48 hours post-operation or discharge 12 Item Short Form Health Survey Version 2 Last preoperative visit to four weeks post-operation 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.
Trial Locations
- Locations (1)
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States