RECRUITING

The Pericapsular Nerve Block in Total Hip Arthroplasty

Conditions

Hip Osteoarthritis Hip Arthropathy Total Hip Arthroplasty Total Hip Replacement Hip Arthroplasty Hip Replacement Postoperative Pain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Pericapsular Nerve Block in Total Hip Arthroplasty: a Randomized, Controlled Trial

Quick Facts

Study Start:2020-12-09

Study Completion:2025-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04729686

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	* 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

Inclusion Criteria

Exclusion 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)

* 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

Contacts and Locations

Study Contact

Martin Gesheff

CONTACT

410-601-9467

mgesheff@lifebridgehealth.org

Nirav Patel

CONTACT

nirpatel@lifebridgehealth.org

Principal Investigator

Ronald Delanois, MD

PRINCIPAL_INVESTIGATOR

LifeBridge Health

Study Locations (Sites)

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215

United States

Collaborators and Investigators

Sponsor: LifeBridge Health

Ronald Delanois, MD, PRINCIPAL_INVESTIGATOR, LifeBridge Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-09

Study Completion Date2025-12-01

Study Record Updates

Study Start Date2020-12-09

Study Completion Date2025-12-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Hip Osteoarthritis
Hip Arthropathy