- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06278987
Comparison of Cryoablation of Pericapsular Nerve Group (PENG) to Fascia Iliaca Catheter in Patients With a Hip Fracture
November 24, 2025 updated by: University of Minnesota
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
150
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Candace Nelson
- Email: nelso377@umn.edu
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55414
- Recruiting
- University of Minnesota
-
Contact:
- Candace Nelson
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients undergoing hip fracture repair aged 18-85.
Exclusion Criteria:
- Patients who have an exclusion to regional anesthesia.
- Patients who are pregnant assessed via self-report or pregnancy test if they have taken one.
- Non-English speakers
- Patients who already had their fracture repaired"
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PENG block and cryoablation
Patients undergoing hip fracture repair aged 18-85
|
will receive an ultrasound guided PENG block with 20 mL of 0.5% bupivacaine followed by cryoablation of the PENG nerves.
|
|
Experimental: fascia iliaca compartment block
Patients undergoing hip fracture repair aged 18-85
|
will receive an ultrasound guided fascia iliaca compartment catheter with initial bolus of 20 mL of 0.5% bupivacaine followed by infusion of 0.2% ropivacaine at 10 mL per hour
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximum pain score on Post-operative day 30
Time Frame: 30 days post surgery
|
Maximum pain score on day 30 post surgery.
Pain Scale is 0-10 with 0 meaning no pain (better outcome) and 10 meaning worst pain imaginable (worse outcome).
|
30 days post surgery
|
|
Opioid use
Time Frame: day 0, 1, 2, 3, 4, 5, 6, 7 post surgery
|
Opioid use and Functional Pain scores on POD 0, 1, 2, 3, 4, 5, 6, 7 - measured in milligrams morphine equivalents
|
day 0, 1, 2, 3, 4, 5, 6, 7 post surgery
|
|
functional pain scores
Time Frame: day 0, 1, 2, 3, 4, 5, 6, 7 post surgery post surgery
|
Functional Pain Score on Post Operative Day 0, 1, 2, 3, 4, 5, 6, 7 - measured with Pain Scale 0-10 with 0 meaning no pain (better outcome) and 10 meaning worst pain imaginable (worse outcome)
|
day 0, 1, 2, 3, 4, 5, 6, 7 post surgery post surgery
|
|
number of patients using opioids
Time Frame: 30 days post surgery
|
measured in number of patients
|
30 days post surgery
|
|
Length of Hospital Stay
Time Frame: 30 days post surgery
|
measured in number of days
|
30 days post surgery
|
|
Time to first ambulation
Time Frame: 30 days post surgery
|
measured in Days:Hours:Minutes post operation
|
30 days post surgery
|
|
Number of patients returned home by Post Operative Day 30
Time Frame: 30 days post surgery
|
measured in number of patients
|
30 days post surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jason Habeck, University of Minnesota
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2024
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2027
Study Registration Dates
First Submitted
January 30, 2024
First Submitted That Met QC Criteria
February 23, 2024
First Posted (Actual)
February 26, 2024
Study Record Updates
Last Update Posted (Actual)
November 25, 2025
Last Update Submitted That Met QC Criteria
November 24, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ANES-2024-32661
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Ankara City Hospital BilkentRecruiting
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