Cryoablation vs Fascia Iliaca Block for Hip Fracture

Overseen By Candace Nelson

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Minnesota

Disqualifiers: Pregnancy, Non-English speakers, 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: Unknown

Duration: Immediate post-surgery

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which treatment better alleviates pain for individuals undergoing hip fracture surgery. One group will receive cryoablation, a procedure that uses extreme cold to numb nerves around the hip. The other group will receive a fascia iliaca block, a different type of anesthesia targeting the hip area. The trial seeks participants who have experienced a hip fracture and require surgery. Participants should have no issues with regional anesthesia and should be comfortable speaking English. As a Phase 4 trial, the treatments are already FDA-approved and proven effective, allowing researchers to understand how they benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for these treatments?

Research has shown that cold treatment on the Pericapsular Nerve Group (PENG) is generally safe. Studies have found that this method, known as cryoneurolysis, carries a low risk of side effects and provides long-lasting pain relief without major issues.

For the fascia iliaca catheter, research suggests it is also quite safe. It effectively manages pain from hip fractures and reduces side effects such as breathing issues or nausea.

Both treatments have been well-tolerated in previous studies, making them promising options for controlling pain in hip fracture patients. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for hip fracture pain management because they offer innovative approaches compared to traditional methods like opioids or standard nerve blocks. Cryoablation of the Pericapsular Nerve Group (PENG) is unique because it uses extreme cold to target and deactivate specific pain-conducting nerves, potentially providing longer-lasting pain relief without the side effects of medications. Meanwhile, the Fascia Iliaca Catheter is an advanced nerve block technique that delivers continuous pain relief by bathing the nerve with anesthetic, possibly offering more consistent pain control than single-injection blocks. Both methods aim to improve patient comfort and recovery times while reducing reliance on opioids.

What evidence suggests that this trial's treatments could be effective for hip fracture pain control?

This trial will compare two pain management methods for hip fracture repair: cryoablation of the Pericapsular Nerve Group (PENG) and fascia iliaca catheter block. Research shows that freezing the nerves around the hip, known as cryoablation, effectively reduces pain after hip surgery. Studies have found that patients using this method feel less pain, need fewer painkillers, and experience improved satisfaction after hip procedures.

Conversely, the fascia iliaca catheter block is a well-known method for relieving pain from hip fractures. Research indicates that it reduces the need for opioids, improves anesthesia quality, and has fewer complications compared to other pain management methods. Both treatments have shown promise in managing pain for patients with hip fractures, and this trial will evaluate their effectiveness. ^{2 6 7 8 9}

Who Is on the Research Team?

Jason Habeck

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for patients aged 18-85 who are undergoing hip fracture repair. It's not suitable for individuals outside this age range or those with conditions that might interfere with the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cryoablation of the PENG or fascia iliaca catheter for hip fracture repair

Immediate post-surgery

In-hospital procedure

Follow-up

Participants are monitored for pain control and opioid use for 30 days post-surgery

30 days

Regular assessments on days 0, 1, 2, 3, 4, 5, 6, 7, and 30 post-surgery

Long-term follow-up

Participants' recovery and functional outcomes are assessed

Additional 30 days

What Are the Treatments Tested in This Trial?

Interventions

• Cryoablation of Pericapsular Nerve Group (PENG)
• Fascia Iliaca Catheter

Trial Overview The study compares two pain control methods after hip surgery: cryoablation of the PENG (a nerve group near the hip) and a fascia iliaca compartment block, which is an injection into the groin area to numb nerves affecting the hip.

How Is the Trial Designed?

Group I: fascia iliaca compartment block Experimental Treatment 1 Intervention

Patients undergoing hip fracture repair aged 18-85

Group II: PENG block and cryoablation Experimental Treatment 1 Intervention

Patients undergoing hip fracture repair aged 18-85

Cryoablation of Pericapsular Nerve Group (PENG) is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Cryoablation for:

• Pain management in hip fractures
• Solid tumors in lung, liver, kidney, breast, and prostate

Approved in United States as Cryoablation for:

• Pain management in hip fractures
• Solid tumors in lung, liver, kidney, breast, and prostate
• Arrhythmias

Approved in Canada as Cryoablation for:

• Pain management in hip fractures
• Solid tumors in lung, liver, kidney, breast, and prostate

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

The pericapsular nerve group (PENG) block significantly reduced pain scores and delayed the need for analgesics compared to the fascia iliaca compartment block (FICB) in patients with hip fractures, based on a randomized controlled trial involving 52 participants.

Patients receiving the PENG block consumed significantly less morphine in the first 24 hours post-surgery compared to those receiving the FICB, indicating that PENG may provide superior analgesia for hip fracture pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of pericapsular nerve group (PENG) block with fascia iliaca compartment block (FICB) for pain control in hip fractures: A double-blind prospective randomized controlled clinical trial. Mosaffa, F., Taheri, M., Manafi Rasi, A., et al.[2022]

In a study involving 60 elderly patients with traumatic proximal femoral fractures, the Pericapsular Nerve Group (PENG) block did not show superior pain relief compared to the Fascia Iliaca block (FIB), with both achieving similar rates of analgesic success (53.3% for PENG vs 53.6% for FIB).

The study indicates that PENG block may not be a more effective option for pain management in this patient population, suggesting that FIB remains a viable alternative for treating hip trauma pain in the emergency room.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesic efficacy of Pericapsular Nerve Group (PENG) block compared with Fascia Iliaca Block (FIB) in the elderly patient with fracture of the proximal femur in the emergency room. A randomised controlled trial. Marrone, F., Graziano, G., Paventi, S., et al.[2023]

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]

In a review of six randomized controlled trials involving 258 patients, the pericapsular nerve group block (PENG) was found to significantly reduce opioid consumption compared to the fascia iliaca compartment block (FICB) after hip surgeries, suggesting better pain management with PENG.

However, there was no significant difference in pain scores at 6, 12, or 24 hours post-surgery between the two groups, indicating that while PENG may reduce the need for opioids, it does not necessarily lead to lower pain levels compared to FICB.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of pericapsular nerve group block vs. fascia iliaca compartment block for Hip surgeries: A systematic review and meta-analysis. Ying, H., Chen, L., Yin, D., et al.[2023]

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]

In a study of 59 elderly patients undergoing hip fracture surgery, adding a pericapsular nerve group (PENG) block to a fascia iliaca compartment block (FICB) did not significantly improve pain relief or recovery outcomes compared to FICB alone.

Both groups experienced similar pain scores and recovery times, but the combined FICB + PENG block took significantly longer to perform, indicating that the additional procedure may not be worth the extra time if it does not enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Analgesic effect of adding ultrasound-guided pericapsular nerve group block to suprainguinal fascia iliaca compartment block for hip fracture surgery: A prospective randomized controlled trial. Nuthep, L., Klanarong, S., Tangwiwat, S.[2023]

Citations

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2. sicot-j.org sicot-j.org/articles/sicotj/full_html/2019/01/sicotj190028/sicotj190028.html

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Role of Percutaneous Cryoablation in Bone and Soft ... For those patients needing local tumor control, primary clinical success was achieved in 60% of cases with about 25 months of median follow-up.

4. withpower.com withpower.com/trial/phase-4-fractures-bone-2-2024-2563c

Cryoablation vs Fascia Iliaca Block for Hip Fracture The purpose of this study is to determine if patients with hip fractures who undergo cryoablation of the PENG have improved pain control 30 days from ...

5. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-016-1000-4

The efficacy of continuous-flow cryo and cyclic compression ... Prefracture functional level evaluated by the New Mobility Score predicts in-hospital outcome after hip fracture surgery. Acta Orthop. 2010 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06278987

Comparison of Cryoablation of Pericapsular Nerve Group ... The purpose of this study is to determine if patients with hip fractures who undergo cryoablation of the PENG have improved pain control 30 days from surgery ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0007091225002958

Chemical ablation of pericapsular nerve group with 95% ... Ultrasound-guided ethanol neurolysis of the PENG is a safe and effective intervention for chronic hip pain, providing long-term relief and reducing opioid ...

8. clinicaltrial.be clinicaltrial.be/en/details/451314?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Comparison of Cryoablation of Pericapsular Nerve Group ... The purpose of this study is to determine if patients with hip fractures who undergo cryoablation of the PENG have improved pain control 30 ...

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The applications of cryoneurolysis for acute and chronic pain ... The evidence clearly demonstrates that cryoneurolysis has a low risk profile and when administered appropriately, provides prolonged analgesia without ...