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NCT06278987 Clinical Trial

Comparison of Cryoablation of Pericapsular Nerve Group (PENG) to Fascia Iliaca Catheter in Patients With a Hip Fracture

Hip Fractures Clinical Trial

Official title:
Comparison of Cryoablation of Pericapsular Nerve Group (PENG) to Fascia Iliaca Catheter in Patients With a Hip Fracture

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06278987
Other study ID # ANES-2024-32661
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date June 1, 2024
Est. completion date December 1, 2026

Study information
Verified date March 2024
Source University of Minnesota
Contact Candace Nelson
Email nelso377@umn.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 150
Est. completion date December 1, 2026
Est. primary completion date June 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• PENG block and cryoablation
will receive an ultrasound guided PENG block with 20 mL of 0.5% bupivacaine followed by cryoablation of the PENG nerves.
• fascia iliaca compartment block
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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Minnesota

Outcome
Type Measure Description Time frame Safety issue
Primary 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). 30 days post surgery
Primary Opioid use 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
Primary 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) day 0, 1, 2, 3, 4, 5, 6, 7 post surgery post surgery
Primary number of patients using opioids measured in number of patients 30 days post surgery
Primary Length of Hospital Stay measured in number of days 30 days post surgery
Primary Time to first ambulation measured in Days:Hours:Minutes post operation 30 days post surgery
Primary Number of patients returned home by Post Operative Day 30 measured in number of patients 30 days post surgery
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