Recruiting

Pericapsular Nerve Block

Sponsor:

LifeBridge Health

Code:

NCT04729686

Conditions

Hip Osteoarthritis

Hip Arthropathy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Pericapsular Nerve Block

Fascia Iliaca Nerve Block

Study Details

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.

Conditions

Hip Osteoarthritis

Hip Arthropathy

Study ID

NCT04729686

Start date

Dec 9, 2020

Status verified date

Nov, 2024

Completion date

Dec 1, 2025

Anticipated

Primary completion date

Dec 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

78 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Pericapsular Nerve Block Group

Pericapsular Nerve Block targets the anterior hip capsule by blocking the articular branches of the femoral nerve and accessory obturator nerve.

active comparator: Fascia Iliaca Nerve Block Group

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.

Interventions

Pericapsular Nerve Block

Per Standard Institutional Practice

Fascia Iliaca Nerve Block

Per Standard Institutional Practice

Primary outcome measure

  • Change in Visual Analog Pain Scale (VAS) Score [ Time Frame: Every 4 hours from end of surgery to 48 hours post surgery or discharge ]
  • Postoperative Opioid Consumption in mg [ Time Frame: Surgery to 1 month post surgery ]

Central Contacts and Locations

Central contacts

Martin Gesheff

410-601-9467mgesheff@lifebridgehealth.org

Nirav Patel

nirpatel@lifebridgehealth.org

Locations

Sinai Hospital of Baltimore

Recruiting

Baltimore, Maryland, United States, 21215

Contacts

Martin Gesheff

mgesheff@lifebridgehealth.org

Nirav Patel

nirpatel@lifebridgehealth.org

Principal Investigator:

Ronald Delanois, MD

More Information

Sponsor

LifeBridge Health

Last update posted

Jan 22, 2025

Last verified

Nov, 2024

Keywords

  • Total Hip Arthroplasty
  • Total Hip Replacement
  • Hip Arthroplasty
  • Hip Replacement
  • Postoperative Pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by LifeBridge Health on 2025-01-22.