Nerve Blocks for Hip Osteoarthritis

(PENG Trial)

Overseen By Nirav Patel

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: LifeBridge Health

Must not be taking: Opioids

Disqualifiers: Chronic pain, Ankylosing spondylitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

78 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this 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.

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.

Is the nerve block treatment for hip osteoarthritis safe?

Nerve blocks like the fascia iliaca and pericapsular nerve group blocks have been used in hip surgeries, but they can cause decreased strength in the quadriceps (thigh muscles) and increase the risk of falls. These blocks are generally safe but may not be recommended for routine use due to these side effects. ^{1 2 3 4 5}

How is the Fascia Iliaca Nerve Block and Pericapsular Nerve Block treatment different from other treatments for hip osteoarthritis?

The Fascia Iliaca Nerve Block and Pericapsular Nerve Block are unique because they target specific nerves around the hip joint to relieve pain, potentially reducing the need for opioids and their side effects. These blocks are guided by ultrasound, which helps in precisely targeting the nerves responsible for hip pain, making them a novel approach compared to traditional pain management methods. ^{1 2 3 5 6}

What data supports the effectiveness of the treatment Fascia Iliaca Nerve Block and Pericapsular Nerve Block for hip osteoarthritis?

Research shows that both Fascia Iliaca and Pericapsular Nerve Blocks are effective in reducing pain and improving comfort in patients with hip fractures and during hip surgeries. These treatments help decrease the need for opioids (strong painkillers) and improve patients' ability to move comfortably, which suggests they could be beneficial for hip osteoarthritis as well. ^{1 2 3 5 7}

Who Is on the Research Team?

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

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.

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?

Group I: Fascia Iliaca Nerve Block Group Active Control 1 Intervention

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.

Group II: Pericapsular Nerve Block Group Active Control 1 Intervention

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Patients with higher preoperative psychological distress were more likely to request a fascia iliaca nerve block for pain control after hip arthroscopy, with 70% of distressed patients requesting it compared to only 36% of those with normal distress levels.

The fascia iliaca nerve block significantly improved pain management, as patients who received the block showed a greater reduction in pain scores by discharge from the post-anesthesia care unit compared to those who did not receive the block.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological distress in hip arthroscopy patients affects postoperative pain control. Potter, MQ., Sun, GS., Fraser, JA., et al.[2022]

In a study of 30 elderly patients with femoral neck fractures, fascia iliaca blocks administered via plexus blockade catheters significantly improved sitting scores and passive hip flexion by an average of 44 degrees one hour after the procedure.

Patients without cognitive impairment experienced a notable reduction in pain, with visual analogue scores decreasing from 7.2 to 4.6, indicating that fascia iliaca blocks can effectively enhance pre-operative analgesia and comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-operative analgesia for patients with femoral neck fractures using a modified fascia iliaca block technique. Candal-Couto, JJ., McVie, JL., Haslam, N., et al.[2022]

The PENG (PEricapsular Nerve Group) block is a new ultrasound-guided technique developed to target the hip articular branches of the femoral nerve and accessory obturator nerve, which may improve pain management in hip fracture patients.

This technique aims to provide effective pain relief while minimizing the use of opioids and their associated side effects, as demonstrated in a preliminary application involving 5 consecutive patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pericapsular Nerve Group (PENG) Block for Hip Fracture. Girón-Arango, L., Peng, PWH., Chin, KJ., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial Commentary: The Truth about Peripheral Nerve Blocks and Hip Arthroscopy. Zhang, AL.[2020]

In a study of 107 geriatric hip fracture patients, both single-shot and continuous fascia iliaca nerve blocks were found to be equally effective in reducing opioid consumption and pain scores postoperatively, with no significant differences between the two methods.

Both types of blocks significantly decreased preoperative opioid use, indicating that they are effective pain management strategies for this patient population, but neither method showed a clear advantage over the other.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparison in Outcomes of Preoperative Single-shot versus Continuous Catheter Fascia Iliaca Regional Anesthesia in Geriatric Hip Fracture Patients. Stephan, SR., Garlich, JM., Debbi, EM., et al.[2021]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Randomized comparison between pericapsular nerve group (PENG) block and suprainguinal fascia iliaca block for total hip arthroplasty. [2022]

2. Brazil pubmed.ncbi.nlm.nih.gov

Pericapsular Nerve Group (PENG) block versus fascia iliaca compartment (FI) block for hip surgery: a systematic review and meta-analysis of randomized controlled trials. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Psychological distress in hip arthroscopy patients affects postoperative pain control. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Pre-operative analgesia for patients with femoral neck fractures using a modified fascia iliaca block technique. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Pericapsular Nerve Group (PENG) Block for Hip Fracture. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Editorial Commentary: The Truth about Peripheral Nerve Blocks and Hip Arthroscopy. [2020]

7. Netherlands pubmed.ncbi.nlm.nih.gov

A Comparison in Outcomes of Preoperative Single-shot versus Continuous Catheter Fascia Iliaca Regional Anesthesia in Geriatric Hip Fracture Patients. [2021]