The Pericapsular Nerve Block in Total Hip Arthroplasty

NCT04729686 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 1665162
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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

Keywords

Total Hip Arthroplasty; Total Hip Replacement; Hip Arthroplasty; Hip Replacement; Postoperative Pain

Outcome Measures

Primary Outcomes (2)

• Change in Visual Analog Pain Scale (VAS) Score

  Score recorded by drawing a vertical line on a 100 mm horizontal line between "No Pain" (0 mm) and "Worst Pain" (100 mm)

  Every 4 hours from end of surgery to 48 hours post surgery or discharge

• Postoperative Opioid Consumption in mg

  Total opioid consumption will be recorded during postoperative period and at 1 month follow-up visit

  Surgery to 1 month post surgery

Secondary Outcomes (6)

• Time to first opioid medication

  End of surgery 48 hours post-operation or discharge

• Time to first ambulation

  End of surgery to 48 hours post-operation or discharge

• Distance upon first ambulation

  48 hours postoperative 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

Study Arms (2)

Pericapsular Nerve Block Group

ACTIVE COMPARATOR

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

Drug: Pericapsular Nerve Block

Fascia Iliaca Nerve Block Group

ACTIVE COMPARATOR

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.

Drug: Fascia Iliaca Nerve Block

Interventions

Pericapsular Nerve Block DRUG

Per Standard Institutional Practice

Pericapsular Nerve Block Group

Fascia Iliaca Nerve Block DRUG

Per Standard Institutional Practice

Fascia Iliaca Nerve Block Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify 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

Sponsors & Collaborators

• LifeBridge Health: lead
• Rubin Institute for Advanced Orthopedics: collaborator

Study Sites (1)

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip; Pain, Postoperative

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Ronald Delanois, MD

  LifeBridge Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Gesheff

CONTACT

410-601-9467; mgesheff@lifebridgehealth.org

Nirav Patel

CONTACT

nirpatel@lifebridgehealth.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: January 28, 2021
• Study Start: December 9, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 22, 2025

Record last verified: 2024-11

Locations

US (1)