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Clinical Trials/NCT06278987
NCT06278987
Recruiting
Phase 4

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

University of Minnesota1 site in 1 country150 target enrollmentOctober 1, 2024

Overview

Phase
Phase 4
Intervention
PENG block and cryoablation
Conditions
Hip Fractures
Sponsor
University of Minnesota
Enrollment
150
Locations
1
Primary Endpoint
Maximum pain score on Post-operative day 30
Status
Recruiting
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2024
End Date
October 1, 2027
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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"

Arms & Interventions

PENG block and cryoablation

Patients undergoing hip fracture repair aged 18-85

Intervention: PENG block and cryoablation

fascia iliaca compartment block

Patients undergoing hip fracture repair aged 18-85

Intervention: fascia iliaca compartment block

Outcomes

Primary Outcomes

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).

Time to first ambulation

Time Frame: 30 days post surgery

measured in Days:Hours:Minutes post operation

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

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

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 returned home by Post Operative Day 30

Time Frame: 30 days post surgery

measured in number of patients

Study Sites (1)

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