What this study is
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.
What's being tested
- Pericapsular Nerve Block
Intervention · DRUG
- Fascia Iliaca Nerve Block
Intervention · DRUG
Both interventions
Per Standard Institutional Practice
Study details
- Official title
- The Pericapsular Nerve Block in Total Hip Arthroplasty: A Randomized, Controlled Trial
- Sponsor
- LifeBridge Health
- Conditions
- Hip Osteoarthritis · Hip Arthropathy
- Enrolling
- 78 people
- Starts
- 2020-12-09
- Est. completion
- 2025-12-01
- Design
- Open-label, randomized, parallel groups, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 80 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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)
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openSinai Hospital of Baltimore
Baltimore, Maryland, United States
- Martin Gesheff · Contactmgesheff@lifebridgehealth.org
- Nirav Patel · Contactnirpatel@lifebridgehealth.org
- Ronald Delanois, MD · Principal investigator
- James Nace, DO · Sub-investigator
- Ethan Remily, DO · Sub-investigator
Recruiting
Study team
Sponsor
LifeBridge Health
Study ID 1665162
Principal investigator
Ronald Delanois, MD
LifeBridge Health
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.