NCT04729686 The Pericapsular Nerve Block in Total Hip Arthroplasty
| NCT ID | NCT04729686 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | LifeBridge Health |
| Condition | Hip Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 78 participants |
| Start Date | 2020-12-09 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 78 participants in total. It began in 2020-12-09 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Ronald Delanois, MD
PRINCIPAL INVESTIGATOR
LifeBridge Health
Frequently Asked Questions
Who can join the NCT04729686 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Hip Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04729686 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04729686 currently recruiting?
Yes, NCT04729686 is actively recruiting participants. Contact the research team at mgesheff@lifebridgehealth.org for enrollment information.
Where is the NCT04729686 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT04729686 clinical trial?
NCT04729686 is sponsored by LifeBridge Health. The principal investigator is Ronald Delanois, MD at LifeBridge Health. The trial plans to enroll 78 participants.