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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from block administration until time of surgery or 24 hours if surgery performed >24 hours
Awards & highlights
No Placebo-Only Group
Summary
This trial compares two methods of numbing the hip area in elderly patients with hip fractures. These methods aim to reduce pain and may be more effective and safer than traditional pain medications.
Who is the study for?
This trial is for emergency department patients with hip fractures, specifically femoral neck or intertrochanteric fractures. Participants must consent to the procedure and not have allergies to local anesthetics. Those with severe injuries causing instability, serious unstable medical conditions, or hemodynamic instability cannot join.
What is being tested?
The study compares two regional anesthesia techniques: PENG (Pericapsular Nerve Group) block and FICB (Fascia Iliaca Compartment Block), in terms of pain control effectiveness for hip fracture patients. The hypothesis suggests that PENG might be more effective based on prior studies.
What are the potential side effects?
Potential side effects may include discomfort at the injection site, possible nerve damage, infection risk at the injection area, bleeding complications due to needle insertion, and allergic reactions to the anesthetic used.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from block administration until time of surgery or 24 hours if surgery performed >24 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from block administration until time of surgery or 24 hours if surgery performed >24 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain score
Secondary study objectives
Opioid use
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: PENGActive Control1 Intervention
Patients with hip fracture randomized to receive PENG block
Group II: FICBActive Control1 Intervention
Patients with hip fracture randomized to received FICB
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The Pericapsular Nerve Group (PENG) block is a regional anesthesia technique that targets the nerves supplying the hip joint to reduce pain perception by injecting local anesthetics near the nerves, thereby blocking pain signal transmission to the brain. This method is particularly beneficial for femoral neck fracture patients as it provides effective pain relief, reduces the need for systemic opioids, and minimizes the risk of opioid-related side effects such as delirium, especially in elderly patients.
Similar treatments include the femoral nerve block and the Fascia Iliaca Compartment Block (FICB), which also aim to block nerve signals to alleviate pain. These regional anesthesia techniques are crucial for improving patient comfort, facilitating early mobilization, and potentially enhancing recovery outcomes.
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Who is running the clinical trial?
University of VirginiaLead Sponsor
782 Previous Clinical Trials
1,315,675 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood pressure and heart rate are stable.I do not agree to participate in the study.I have severe, unstable health conditions.I have a broken hip bone.
Research Study Groups:
This trial has the following groups:- Group 1: PENG
- Group 2: FICB
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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