78 Participants Needed

Nerve Blocks for Hip Osteoarthritis

(PENG Trial)

MG
NP
Overseen ByNirav Patel
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: LifeBridge Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which nerve block better manages pain after hip replacement surgery: the fascia iliaca nerve block or the pericapsular nerve block. Both methods target specific nerves to reduce pain in the hip area. The trial seeks participants planning to undergo hip replacement using the anterior (front) approach and who have not regularly used opioids (strong pain medications) before. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, allowing researchers to understand how it benefits more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must not be taking opioids regularly before joining. If you are on opioids, you may need to stop them to participate.

What is the safety track record for these treatments?

Research shows that both the fascia iliaca nerve block and the pericapsular nerve block are generally safe for managing pain after hip surgery.

For the fascia iliaca nerve block, studies have found it effectively reduces pain and the need for pain medication like morphine after surgery. Patients using this block experienced less pain and required fewer pain-relieving drugs soon after their operation.

Regarding the pericapsular nerve block, research suggests it also effectively reduces pain and decreases the use of pain medications after surgery. This block targets specific nerves near the hip, aiding in pain management and improving recovery.

Both treatments have been tested in previous studies and have shown positive results in terms of safety and effectiveness. They are generally well-tolerated, with no major safety concerns reported in the available research.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about nerve blocks for hip osteoarthritis because they offer a unique approach compared to traditional pain management options like oral medications or injections. Fascia Iliaca Nerve Block specifically targets the space between the iliacus muscle and fascia, directly affecting the femoral and lateral femoral cutaneous nerves. Meanwhile, the Pericapsular Nerve Block focuses on the anterior hip capsule, blocking the articular branches of the femoral and accessory obturator nerves. These targeted techniques aim to provide more precise pain relief, potentially reducing side effects associated with systemic treatments. This precision in targeting could mean faster and more effective relief for patients suffering from hip osteoarthritis.

What evidence suggests that this trial's nerve block treatments could be effective for hip osteoarthritis?

This trial will compare the effectiveness of two nerve block treatments for hip osteoarthritis: the Fascia Iliaca Nerve Block and the Pericapsular Nerve Block. Studies have shown that fascia iliaca nerve blocks effectively reduce pain and the need for opioids after hip surgeries, providing good pain relief for up to 24 hours. Research indicates that patients using fascia iliaca blocks often require less morphine and experience shorter hospital stays.

The pericapsular nerve block also lowers pain and opioid use, improving hip function after surgery. Some studies suggest that this block reduces pain for up to two months in hip osteoarthritis patients. Both treatments have shown promise in managing hip pain, making them valuable options for pain control after hip surgery. Participants in this trial will receive one of these nerve block treatments to evaluate their effectiveness in managing hip pain.23678

Who Is on the Research Team?

RD

Ronald Delanois, MD

Principal Investigator

LifeBridge Health

Are You a Good Fit for This Trial?

This trial is for adults planning to undergo primary total hip arthroplasty using the anterior approach, with an ASA score of 1-3, and who have not been taking opioids. They must be willing to follow study procedures and provide consent. Excluded are those with general anesthesia during surgery, certain conditions like ankylosing spondylitis or chronic pain, opioid tolerance, or allergies to medications used in the nerve blocks.

Inclusion Criteria

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
See 3 more

Exclusion Criteria

During the surgery, the patient needs to be fully asleep under general anesthesia.
You have been diagnosed with a condition called ankylosing spondylitis.
You are currently receiving treatment with another experimental drug or any other therapy for pain.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative

Scheduled pre-operative visit for preparation and baseline assessments

1 visit
1 visit (in-person)

Operative

Participants undergo total hip arthroplasty with assigned nerve block regimen

1 day
1 visit (in-person)

Post-operative

Participants receive postoperative care and pain management, including monitoring of opioid consumption

48 hours
Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments at 2-week and 4-6 week intervals

4-6 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Fascia Iliaca Nerve Block
  • Pericapsular Nerve Block
Trial Overview The study compares two types of nerve blocks for managing postoperative pain after hip replacement surgery: pericapsular nerve block versus fascia iliaca nerve block. The goal is to determine which method better supports outpatient recovery by effectively controlling pain.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: Fascia Iliaca Nerve Block GroupActive Control1 Intervention
Group II: Pericapsular Nerve Block GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

LifeBridge Health

Lead Sponsor

Trials
32
Recruited
4,500+

Rubin Institute for Advanced Orthopedics

Collaborator

Trials
2
Recruited
180+

Published Research Related to This Trial

In a study of 40 patients undergoing total hip arthroplasty, the pericapsular nerve group block significantly reduced the incidence of quadriceps motor block at 3 hours (45% vs 90%) and 6 hours (25% vs 85%) compared to the suprainguinal fascia iliaca block, indicating better preservation of motor function.
Both techniques showed similar outcomes in terms of postoperative pain, opioid consumption, and ability to perform physiotherapy, suggesting that while the pericapsular nerve group block is more effective in preserving motor function, it does not compromise overall pain management or recovery.
Randomized comparison between pericapsular nerve group (PENG) block and suprainguinal fascia iliaca block for total hip arthroplasty.Aliste, J., Layera, S., Bravo, D., et al.[2022]
In a study of 384 patients undergoing hip surgery, the Pericapsular Nerve Group (PENG) block was found to significantly reduce static pain scores at 12 hours post-surgery and decrease opioid consumption in the first 24 hours compared to the Fascia Iliaca compartment (FI) block.
However, there were no significant differences in pain scores at 6 or 24 hours post-surgery or in the time to first analgesic rescue between the two techniques, indicating that while PENG may offer some immediate benefits, further research is needed to fully understand its advantages over FI block.
Pericapsular Nerve Group (PENG) block versus fascia iliaca compartment (FI) block for hip surgery: a systematic review and meta-analysis of randomized controlled trials.Andrade, PP., Lombardi, RA., Marques, IR., et al.[2023]
Recent high-level randomized controlled trials indicate that fascia iliaca compartment blocks do not provide better postoperative pain relief than sham injections after hip arthroscopy surgery.
These blocks can lead to decreased quadriceps strength and increased fall risk, making them less effective and potentially harmful compared to local anesthetic injections at the surgery site.
Editorial Commentary: The Truth about Peripheral Nerve Blocks and Hip Arthroscopy.Zhang, AL.[2020]

Citations

Effects of pericapsular nerve group block and fascia Iliaca ...This block provides effective analgesia for the anterior and lateral aspects of the hip joint, which are often the primary sources of pain ...
The efficacy of fascia iliaca compartment block for pain ...FICB could be used to effectively reduce pain intensity up to 24 h, total morphine consumption, and length of hospital stay in THA patients.
Fascia iliaca compartment block reduces pain and opioid ...Fascia iliaca compartment block was effective for pain relief during the early post-operative period after total hip arthroplasty.
Comparison of the efficacy and safety of different puncture . ...FICB has been shown to reduce opioid consumption and lower pain scores after hip arthroplasty and is one of the main methods for pain control ...
Fascia iliaca compartment block for postoperative pain after ...FICB significantly reduces the total analgesic consumption up to 48 h; however, it is not effective in reducing post-operative pain, nausea and vomiting.
The efficiency and safety of fascia iliaca block for pain ...The application of fascia iliaca block could significantly reduce VAS scores and morphine consumption at 12 and 24 hours following total knee and hip ...
Effects of pericapsular nerve group block and fascia Iliaca ...During activity, the PENG group consistently reported lower pain scores at 2, 6, and 8 h compared to the FICB group. At 8 h, the PENG group's ...
Effectiveness and Safety of Lumbar Erector Spinae Plane ...We hypothesize that patients receiving L-ESPB compared to those without block will have lower opioid consumption and less pain after hip surgery ...
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