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

Trial Summary

What is the purpose of this trial?

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 when compared to those who have a fascia iliaca catheter.

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 data supports the effectiveness of the treatment Cryoablation vs Fascia Iliaca Block for Hip Fracture?

Research shows that both the Pericapsular Nerve Group (PENG) block and the Fascia Iliaca Block are used to manage pain in hip fracture patients, with PENG potentially offering better pain control and aiding in faster recovery. Studies suggest that PENG block may be more effective than Fascia Iliaca Block in providing pain relief after hip surgery. ^{1 2 3 4 5}

Is cryoablation or fascia iliaca block safe for hip fracture treatment?

The studies reviewed focus on the effectiveness of PENG and fascia iliaca blocks for pain management in hip surgeries, but they do not provide specific safety data. However, these techniques are commonly used for their pain-relieving benefits and to reduce the need for opioids, which suggests a level of safety in their application. ^{2 3 4 5 6}

How does the treatment of Cryoablation of Pericapsular Nerve Group (PENG) differ from other treatments for hip fracture?

Cryoablation of the Pericapsular Nerve Group (PENG) is a novel treatment that uses cold temperatures to target specific nerves around the hip, potentially offering more precise pain relief compared to traditional methods like the Fascia Iliaca Block, which may not provide sufficient analgesia. This approach is unique because it is guided by ultrasound to specifically block the articular branches of the femoral and accessory obturator nerves, which may help reduce the need for opioids and improve early rehabilitation. ^{1 2 3 4 5}

Research Team

Jason Habeck

Principal Investigator

University of Minnesota

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

References

1. France 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. [2022]

2. England pubmed.ncbi.nlm.nih.gov

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

3. United States 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. [2023]

4. Switzerland 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. [2023]

5. 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]

6. Spain 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. [2023]