Hip FracturesPhase 4NCT06278987
Comparison of Cryoablation of Pericapsular Nerve Group (PENG) to Fascia Iliaca Catheter in Patients With a Hip Fracture
A Phase 4 study testing PENG block and cryoablation and fascia iliaca compartment block in people with Hip Fractures, run by University of Minnesota.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hip Fractures
- What is being tested?
- PENG block and cryoablation and fascia iliaca compartment block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 1 Oct 2027
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing hip fracture repair aged 18-85.
Who cannot join
- 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"
About this study
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.
- Conditions
- Hip Fractures
- Being tested
- PENG block and cryoablation, fascia iliaca compartment block
- Keywords
- Hip fractures
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENG block and cryoablationDrug
will receive an ultrasound guided PENG block with 20 mL of 0.5% bupivacaine followed by cryoablation of the PENG nerves.
fascia iliaca compartment blockDrug
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
| Study group | Role | What they receive |
|---|---|---|
| PENG block and cryoablation | Experimental | Patients undergoing hip fracture repair aged 18-85 Receives: Drug: PENG block and cryoablation |
| fascia iliaca compartment block | Experimental | Patients undergoing hip fracture repair aged 18-85 Receives: Drug: fascia iliaca compartment block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum pain score on Post-operative day 30
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).
Measured: 30 days post surgery
Opioid use
Opioid use and Functional Pain scores on POD 0, 1, 2, 3, 4, 5, 6, 7 - measured in milligrams morphine equivalents
Measured: day 0, 1, 2, 3, 4, 5, 6, 7 post surgery
functional pain scores
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)
Measured: day 0, 1, 2, 3, 4, 5, 6, 7 post surgery post surgery
number of patients using opioids
measured in number of patients
Measured: 30 days post surgery
Length of Hospital Stay
measured in number of days
Measured: 30 days post surgery
Time to first ambulation
measured in Days:Hours:Minutes post operation
Measured: 30 days post surgery
Number of patients returned home by Post Operative Day 30
measured in number of patients
Measured: 30 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start1 Oct 2024
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Why it stopped: The study was terminated early due to operational feasibility challenges, including competing clinical priorities and resource constraints.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized prospective controlled trial. This will be single blinded trial. Randomization will be 1:1
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Habeck, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278987
- Sponsor's protocol ID
- ANES-2024-32661
- Status last verified
- Oct 2026
- First submitted
- 30 Jan 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cryoablation of Pericapsular Nerve Group (PENG) to Fascia Iliaca Catheter in Patients With a Hip Fracture
- ClinicalTrials.gov ID
- NCT06278987
- Acronym / sponsor ID
- ANES-2024-32661
- Conditions
- Hip Fractures
- Keywords
- Hip fractures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was terminated early due to operational feasibility challenges, including competing clinical priorities and resource constraints.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized prospective controlled trial. This will be single blinded trial. Randomization will be 1:1
| Arm | Type | Receives |
|---|---|---|
| PENG block and cryoablation | Experimental | Drug: PENG block and cryoablationPatients undergoing hip fracture repair aged 18-85 |
| fascia iliaca compartment block | Experimental | Drug: fascia iliaca compartment blockPatients undergoing hip fracture repair aged 18-85 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing hip fracture repair aged 18-85.
Key exclusion criteria (4 listed)
- 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"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PENG block and cryoablationwill receive an ultrasound guided PENG block with 20 mL of 0.5% bupivacaine followed by cryoablation of the PENG nerves. | Drug | PENG block and cryoablation |
| fascia iliaca compartment blockwill 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 | Drug | fascia iliaca compartment block |
Primary outcome
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).
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
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)
number of patients using opioids
Time frame: 30 days post surgery
measured in number of patients
Length of Hospital Stay
Time frame: 30 days post surgery
measured in number of days
Time to first ambulation
Time frame: 30 days post surgery
measured in Days:Hours:Minutes post operation
Number of patients returned home by Post Operative Day 30
Time frame: 30 days post surgery
measured in number of patients
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Habeck principal investigator
University of Minnesota
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PENG block and cryoablation and fascia iliaca compartment block in people with Hip Fractures, run by University of Minnesota.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum pain score on Post-operative day 30 (time frame: 30 days post surgery). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.