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

NCT06278987 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: ANES-2024-32661
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Fractures

Keywords

Hip fractures

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• number of patients using opioids

  measured in number of patients

  30 days post surgery

• Length of Hospital Stay

  measured in number of days

  30 days post surgery

• Time to first ambulation

  measured in Days:Hours:Minutes post operation

  30 days post surgery

• Number of patients returned home by Post Operative Day 30

  measured in number of patients

  30 days post surgery

Study Arms (2)

PENG block and cryoablation

EXPERIMENTAL

Patients undergoing hip fracture repair aged 18-85

Drug: PENG block and cryoablation

fascia iliaca compartment block

EXPERIMENTAL

Patients undergoing hip fracture repair aged 18-85

Drug: fascia iliaca compartment block

Interventions

PENG block and cryoablation DRUG

will receive an ultrasound guided PENG block with 20 mL of 0.5% bupivacaine followed by cryoablation of the PENG nerves.

PENG block and cryoablation

fascia iliaca compartment block DRUG

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

fascia iliaca compartment block

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing hip fracture repair aged 18-85.

You may not qualify if:

• 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"

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

RECRUITING

MeSH Terms

Conditions

Hip Fractures

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Jason Habeck

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Candace Nelson

CONTACT

nelso377@umn.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized prospective controlled trial. This will be single blinded trial. Randomization will be 1:1

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 26, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

US (1)