Status:
RECRUITING
The Pericapsular Nerve Block in Total Hip Arthroplasty
Lead Sponsor:
LifeBridge Health
Collaborating Sponsors:
Rubin Institute for Advanced Orthopedics
Conditions:
Hip Osteoarthritis
Hip Arthropathy
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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 t...
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 sta...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT04729686
Start Date
December 9 2020
End Date
December 1 2025
Last Update
January 22 2025
Active Locations (1)
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1
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215