PENG vs FIC Nerve Blocks for Hip Fracture Pain

Recruiting in Palo Alto (17 mi)

Overseen by Lawrence Haines, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Antonios Likourezos

Must not be taking: Opioids

Disqualifiers: Multi-system trauma, Pregnancy, Intoxication, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Ultrasound-guided nerve blocks are an important tool for treating pain due to orthopedic injury in the ED. They provide long lasting, opioid-sparing pain relief that is generally safe and well-tolerated by patients1. Elderly patients with hip fractures commonly present to the ED, and their injury can be painful. Commonly used opioid pain regimens can have deleterious side effects, especially in elderly patients, like somnolence, delirium, hypotension and respiratory depression. The fascia iliaca compartment (FIC) block has become a familiar technique to emergency physicians as a pain control treatment for hip fractures. The pericapsular nerve group (PENG) block has recently been proposed as a novel method to treat pain due to hip, acetabular and pelvic fracture by targeting the terminal sensory articular nerve branches of the femoral nerve (FN), obturator nerve (ON), and accessory obturator nerve (AON). At this time there has been no study comparing the efficacy of the two nerve blocks, PENG and FIC. This aim of this study is to compare the efficacy of the PENG block (20mL of Bupivacaine 0.50%) to that of the FIC block (40mL of Bupivacaine 0.25%) for patients with hip fractures in the ED. Our hypothesis is that PENG will demonstrate analgesia that is non-inferior to FIC. Subjective pain scores on a scale of 0 to 10 will be assessed before and after the block. All subjects will receive 4mg of morphine after consent and prior to the block.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but it does exclude patients who are on long-term systemic opioid analgesia.

What data supports the effectiveness of the PENG and FIC nerve block treatments for hip fracture pain?

Research shows that both the PENG block and the FIC block are used to manage pain after hip surgeries. The PENG block may help with faster recovery after surgery, and it is considered a good alternative for pain management in hip fractures.

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Is the PENG or FIC nerve block safe for humans?

The research articles focus on comparing the effectiveness of PENG and FIC nerve blocks for pain control in hip surgeries, but they do not provide specific safety data. Generally, both techniques are used in clinical settings, suggesting they are considered safe, but specific safety outcomes are not detailed in these studies.

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How does the PENG block treatment differ from other treatments for hip fracture pain?

The PENG block is a novel treatment for hip fracture pain that may offer better pain relief and faster recovery compared to the more commonly used FIC block. It is a motor-sparing technique, which means it helps manage pain without significantly affecting muscle movement, potentially aiding in quicker rehabilitation.

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Eligibility Criteria

This trial is for adults over 18 with an isolated hip fracture and a pain score of 5 or more. It's not for those with multiple injuries, communication issues about pain, pregnancy, under 18 years old, intoxication, abnormal vital signs, long-term opioid use or allergy to certain local anesthetics.

Inclusion Criteria

I have a hip fracture near the top of my thigh bone.

My pain level is 5 or higher on a scale of 0 to 10 before getting a nerve block.

I am over 18 and need emergency medical care.

Exclusion Criteria

Allergy to amide local anesthetics

I cannot express how much pain I am in.

I am on long-term pain medication.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either a PENG block or a FIC block for pain management in the ED

1 day

1 visit (in-person)

Immediate Follow-up

Participants' pain scores and motor function are assessed at 30 and 60 minutes post nerve block

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any adverse events and rescue medication usage after the nerve block

1-2 weeks

Participant Groups

The study compares two types of nerve blocks in emergency department patients with hip fractures: PENG block using Bupivacaine (0.50%) and FIC block using Bupivacaine (0.25%). The goal is to see if PENG provides similar or better pain relief than FIC without opioids.

Group I: PENG Block Active Control 1 Intervention

Pericapsular Nerve Group (PENG) Block (20mL of Bupivacaine 0.50%)

Group II: Fascia Iliaca Compartment Active Control 1 Intervention

Fascial Iliaca block (FIC) (40mL of Bupivacaine 0.25%) for patients with hip fractures in the ED

FIC Proceedure is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Fascia Iliaca Compartment Block for:

• Pain management for hip fractures
• Pain management for orthopedic injuries

🇪🇺 Approved in European Union as Fascia Iliaca Compartment Block for:

• Pain management for hip fractures
• Pain management for orthopedic injuries

🇨🇦 Approved in Canada as Fascia Iliaca Compartment Block for:

• Pain management for hip fractures
• Pain management for orthopedic injuries

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Maimonides Medical Center Brooklyn, NY

Who Is Running the Clinical Trial?

Antonios Likourezos Lead Sponsor

References

1. 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] The review aimed to compare outcomes of pericapsular nerve group block (PENG) vs. fascia iliaca compartment block (FICB) for patients undergoing hip surgeries.

2. 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] Both suprainguinal ultrasound-guided fascia iliaca compartment block (FICB) and pericapsular nerve group (PENG) block have been used to treat pain after hip surgery. Motor-sparing PENG block may further expedite early postoperative rehabilitation. This study aimed to compare the analgesic efficacy and recovery outcome of suprainguinal ultrasound-guided FICB alone with FICB combined with PENG block for hip fracture surgery.

3. 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] This study compares Fascia Iliaca compartment (FI) block and Pericapsular Nerve Group (PENG) block for hip surgery.

4. 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] Fascia iliaca compartment block (FICB) is a common regional analgesic strategy in hip fracture surgery but, recently it has been suggested that FICB may not provide enough analgesia. Pericapsular nerve group block (PENG) is a novel method for hip analgesia which its efficacy is not well established yet. The aim of this study was to the effect of the PENG block in the control of the hip fracture pain as well as to compare the effectiveness of the PENG compared with FICB.

5. India pubmed.ncbi.nlm.nih.gov

Comparison of Pericapsular Nerve Group Block versus Fascia Iliaca Compartment Block as Postoperative Pain Management in Hip Fracture Surgeries. [2022] Postoperative pain management and early recovery play an important role in the functional outcome following hip surgeries. Recently, pericapsular nerve group (PENG) block has been used as a good alternative for postoperative pain management following hip fracture surgeries. We compared the efficacy of (PENG) block and fascia iliaca compartment block (FICB) as postoperative pain management in hip surgeries.

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] Data on the efficacy of PENG (Pericapsular Nerve Group) block in hip trauma pain are scarce. We hypothesized that PENG block was more effective than infra-inguinal ultrasound-guided FIB (Fascia Iliaca block) for pain control in patients aged 65 years or older presenting in the emergency room (ER) with traumatic proximal femoral fracture.