Hip OsteoarthritisPhase 4PENGNCT04729686
The Pericapsular Nerve Block in Total Hip Arthroplasty
A Phase 4 study testing Pericapsular Nerve Block and Fascia Iliaca Nerve Block in people with Hip Osteoarthritis and Hip Arthropathy, run by LifeBridge Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hip Osteoarthritis, Hip Arthropathy
- What is being tested?
- Pericapsular Nerve Block and Fascia Iliaca Nerve Block
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2020to 1 Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nirav Patel contact
United States1 site, 1 recruiting
- Recruiting
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Martin Gesheff, mgesheff@lifebridgehealth.org
Nirav Patel, nirpatel@lifebridgehealth.org
About this study
Official title: The Pericapsular Nerve Block in Total Hip Arthroplasty: A Randomized, Controlled Trial
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.
Read the 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.
- Conditions
- Hip Osteoarthritis, Hip Arthropathy
- Being tested
- Pericapsular Nerve Block, Fascia Iliaca Nerve Block
- Keywords
- Total Hip Arthroplasty, Total Hip Replacement, Hip Arthroplasty, Hip Replacement, Postoperative Pain
- Medical subject headings
- Osteoarthritis, Hip, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pericapsular Nerve BlockDrug
Per Standard Institutional Practice
Fascia Iliaca Nerve BlockDrug
Per Standard Institutional Practice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Fascia Iliaca Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: Surgery to 1 month post surgery
Secondary outcomes (6)
Time to first opioid medication
Measured: End of surgery 48 hours post-operation or discharge
Time to first ambulation
Measured: End of surgery to 48 hours post-operation or discharge
Distance upon first ambulation
Measured: 48 hours postoperative or discharge
Incidence of weakness and falls
Measured: End of surgery to 48 hours post-operation or discharge
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.
Measured: Last preoperative visit to four weeks post-operation
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.
Measured: Last preoperative visit to four weeks post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start9 Dec 2020
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LifeBridge Health
- Sponsor type
- University, hospital or other
- Collaborators
- Rubin Institute for Advanced Orthopedics
- Responsible party
- Sponsor
- Investigators
- Ronald Delanois, MD, Principal investigator, LifeBridge Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04729686
- Sponsor's protocol ID
- 1665162
- Acronym
- PENG
- Status last verified
- Nov 2024
- First submitted
- 22 Dec 2020
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pericapsular Nerve Block in Total Hip Arthroplasty: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT04729686
- Acronym / sponsor ID
- PENG / 1665162
- Conditions
- Hip Osteoarthritis, Hip Arthropathy
- Keywords
- Total Hip Arthroplasty, Total Hip Replacement, Hip Arthroplasty, Hip Replacement, Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- LifeBridge HealthUniversity, hospital or other
- Collaborators
- Rubin Institute for Advanced Orthopedics
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 28 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pericapsular Nerve Block Group | Active comparator | Drug: Pericapsular Nerve BlockPericapsular Nerve Block targets the anterior hip capsule by blocking the articular branches of the femoral nerve and accessory obturator nerve. |
| Fascia Iliaca Nerve Block Group | Active comparator | Drug: Fascia Iliaca Nerve BlockFascia 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pericapsular Nerve BlockPer Standard Institutional Practice | Drug | Pericapsular Nerve Block Group |
| Fascia Iliaca Nerve BlockPer Standard Institutional Practice | Drug | Fascia Iliaca Nerve Block Group |
Primary outcome
Change in Visual Analog Pain Scale (VAS) Score
Time frame: Every 4 hours from end of surgery to 48 hours post surgery or discharge
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
Time frame: Surgery to 1 month post surgery
Total opioid consumption will be recorded during postoperative period and at 1 month follow-up visit
6 secondary outcomes
Time to first opioid medication
Time frame: End of surgery 48 hours post-operation or discharge
Time to first ambulation
Time frame: End of surgery to 48 hours post-operation or discharge
Distance upon first ambulation
Time frame: 48 hours postoperative or discharge
Incidence of weakness and falls
Time frame: End of surgery to 48 hours post-operation or discharge
Harris Hip Score
Time frame: Last preoperative visit to four weeks post-operation
12 Item Short Form Health Survey Version 2
Time frame: Last preoperative visit to four weeks post-operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nirav Patel contact
Ronald Delanois, MD principal investigator
LifeBridge Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pericapsular Nerve Block and Fascia Iliaca Nerve Block in people with Hip Osteoarthritis and Hip Arthropathy, run by LifeBridge Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Gesheff (410-601-9467, mgesheff@lifebridgehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.