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

Phase 4

Recruiting

• Conditions: Hip Fractures
• Interventions: Drug: PENG block and cryoablation; Drug: fascia iliaca compartment block

• Registration Number: NCT06278987
• Lead Sponsor: University of Minnesota

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-30
• Study First Submitted QC: 2024-02-23
• Study First Posted: 2024-02-26
• Study Start: 2024-10-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-18
• Primary Completion: 2026-10-01
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PENG block and cryoablation	PENG block and cryoablation	Patients undergoing hip fracture repair aged 18-85
fascia iliaca compartment block	fascia iliaca compartment block	Patients undergoing hip fracture repair aged 18-85

Primary Outcome Measures

Name	Time	Method
Maximum pain score on Post-operative day 30	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).
Time to first ambulation	30 days post surgery	measured in Days:Hours:Minutes post operation
Opioid use	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
number of patients using opioids	30 days post surgery	measured in number of patients
Length of Hospital Stay	30 days post surgery	measured in number of days
functional pain scores	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 returned home by Post Operative Day 30	30 days post surgery	measured in number of patients

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States