The Pericapsular Nerve Block in Total Hip Arthroplasty (PENG)
Primary Purpose
Hip Osteoarthritis, Hip Arthropathy
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pericapsular Nerve Block
Fascia Iliaca Nerve Block
Sponsored by
About this trial
This is an interventional treatment trial for Hip Osteoarthritis focused on measuring Total Hip Arthroplasty, Total Hip Replacement, Hip Arthroplasty, Hip Replacement, Postoperative Pain
Eligibility Criteria
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
Sites / Locations
- Sinai Hospital of BaltimoreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Pericapsular Nerve Block Group
Fascia Iliaca Nerve Block Group
Arm Description
Pericapsular Nerve Block targets the anterior hip capsule by blocking the articular branches of the femoral nerve and accessory obturator nerve.
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.
Outcomes
Primary Outcome Measures
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)
Postoperative Opioid Consumption in mg
Total opioid consumption will be recorded during postoperative period and at 1 month follow-up visit
Secondary Outcome Measures
Time to first opioid medication
Time to first ambulation
Distance upon first ambulation
Incidence of weakness and falls
Harris Hip Score
10 question items measuring pain severity, function, absence of deformity, and range of motion. Scores range from 0-100 with higher scores representing better outcomes.
12 Item Short Form Health Survey Version 2
12 question items measuring health and well being as reported by the patient. 2 scores are calculated: 1) Physical Component Summary Score (PCS) and (2) Mental Health Component Summary Score (MCS) in which scores range from 0-100 with a score of zero indicating lowest level of health and 100 indicating the highest level of health.
Full Information
NCT ID
NCT04729686
First Posted
December 22, 2020
Last Updated
April 14, 2022
Sponsor
LifeBridge Health
Collaborators
Rubin Institute for Advanced Orthopedics
1. Study Identification
Unique Protocol Identification Number
NCT04729686
Brief Title
The Pericapsular Nerve Block in Total Hip Arthroplasty
Acronym
PENG
Official Title
The Pericapsular Nerve Block in Total Hip Arthroplasty: A Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 9, 2020 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LifeBridge Health
Collaborators
Rubin Institute for Advanced Orthopedics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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 standard of care.
Effective pain control after surgery for total hip replacement is a critical element in patient recovery. Particularly, in the first few days, as majority of patients may experience significant pain. Improved pain management after surgery contributes to better healing, faster patient mobility, shortened hospital stays, and reduced healthcare costs. While pain management is an important factor in total hip replacement, pain after surgery has yet to be improved. Inadequate pain control can lead to delayed movement, thereby increasing the risk for complications such as blood clots in the legs (deep venous thrombosis - blood clots in your veins) with some patients developing blood clots in their lungs (pulmonary embolus). In addition to pain medications after surgery, nerve blocks such as the femoral or fascia iliaca, have been used as supporting therapy for pain management after a total hip replacement. While these nerve blocks are used on a regular basis, they do have limitations which can produce inconsistent results for pain control and use of pain medications after surgery. With no clear superior nerve block for total hip replacement, a new nerve block, called the pericapsular nerve group (PENG) block has emerged. It has demonstrated the ability to prolong pain relief and decrease the use of pain medications after surgery. Therefore, a randomized study comparing the PENG block to other blocks established within the anesthesia community (e.g., fascia iliaca block) will allow for providers to understand the capabilities this block has in the setting of a total hip replacement.
In addition to your normal standard clinical care, there will scheduled pre-operative, operative, 2-week, and 4-6 week follow-up visits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis, Hip Arthropathy
Keywords
Total Hip Arthroplasty, Total Hip Replacement, Hip Arthroplasty, Hip Replacement, Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pericapsular Nerve Block Group
Arm Type
Active Comparator
Arm Description
Pericapsular Nerve Block targets the anterior hip capsule by blocking the articular branches of the femoral nerve and accessory obturator nerve.
Arm Title
Fascia Iliaca Nerve Block Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Pericapsular Nerve Block
Intervention Description
Per Standard Institutional Practice
Intervention Type
Other
Intervention Name(s)
Fascia Iliaca Nerve Block
Intervention Description
Per Standard Institutional Practice
Primary Outcome Measure Information:
Title
Change in Visual Analog Pain Scale (VAS) Score
Description
Score recorded by drawing a vertical line on a 100 mm horizontal line between "No Pain" (0 mm) and "Worst Pain" (100 mm)
Time Frame
Every 4 hours from end of surgery to 48 hours post surgery or discharge
Title
Postoperative Opioid Consumption in mg
Description
Total opioid consumption will be recorded during postoperative period and at 1 month follow-up visit
Time Frame
Surgery to 1 month post surgery
Secondary Outcome Measure Information:
Title
Time to first opioid medication
Time Frame
End of surgery 48 hours post-operation or discharge
Title
Time to first ambulation
Time Frame
End of surgery to 48 hours post-operation or discharge
Title
Distance upon first ambulation
Time Frame
48 hours postoperative or discharge
Title
Incidence of weakness and falls
Time Frame
End of surgery to 48 hours post-operation or discharge
Title
Harris Hip Score
Description
10 question items measuring pain severity, function, absence of deformity, and range of motion. Scores range from 0-100 with higher scores representing better outcomes.
Time Frame
Last preoperative visit to four weeks post-operation
Title
12 Item Short Form Health Survey Version 2
Description
12 question items measuring health and well being as reported by the patient. 2 scores are calculated: 1) Physical Component Summary Score (PCS) and (2) Mental Health Component Summary Score (MCS) in which scores range from 0-100 with a score of zero indicating lowest level of health and 100 indicating the highest level of health.
Time Frame
Last preoperative visit to four weeks post-operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Gesheff
Phone
410-601-9467
Email
mgesheff@lifebridgehealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Nirav Patel
Email
nirpatel@lifebridgehealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Delanois, MD
Organizational Affiliation
LifeBridge Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Gesheff
Email
mgesheff@lifebridgehealth.org
First Name & Middle Initial & Last Name & Degree
Nirav Patel
Email
nirpatel@lifebridgehealth.org
First Name & Middle Initial & Last Name & Degree
Ronald Delanois, MD
First Name & Middle Initial & Last Name & Degree
James Nace, DO
First Name & Middle Initial & Last Name & Degree
Ethan Remily, DO
12. IPD Sharing Statement
Learn more about this trial
The Pericapsular Nerve Block in Total Hip Arthroplasty
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