Cryo Rib Fracture Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-10

Study Completion Date

2027-07-20

Brief Summary

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The purpose of this study is to determine if patients with rib fractures who undergo cryoablation of the intercostal nerves have improved pain control 7 days from procedure when compared to those who have a ESP catheter.

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Detailed Description

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Conditions

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Rib Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized prospective controlled trial. This will be single blinded trial. The individual doing the outcome assessments will be blinded. Randomization will be 1:1.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The individual doing the outcome assessments will be blinded.

Study Groups

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Cryoablation

Participants with rib fracture randomized to Cryoablation.

Group Type EXPERIMENTAL

Cryoablation

Intervention Type DRUG

an injection of 1ml of 1% lidocaine per rib and ultrasound guided cryoablation of the intercostal nerves

ESP catheter

Participants with rib fracture randomized to ESP Catheter.

Group Type ACTIVE_COMPARATOR

ESP Catheter

Intervention Type DRUG

an ultrasound guided erector spinae plane catheter with initial bolus of 30 mL of 0.25% bupivacaine followed by infusion of 0.2% ropivacaine at 10 mL per hour via programmed intermittent bolus.

Interventions

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Cryoablation

an injection of 1ml of 1% lidocaine per rib and ultrasound guided cryoablation of the intercostal nerves

Intervention Type DRUG

ESP Catheter

an ultrasound guided erector spinae plane catheter with initial bolus of 30 mL of 0.25% bupivacaine followed by infusion of 0.2% ropivacaine at 10 mL per hour via programmed intermittent bolus.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who are over 18 who have more than one ribs fractured.

Exclusion Criteria

* Patients who have an exclusion to regional anesthesia.
* Patients who are pregnant via self-report or pregnancy test if they take one.
* Non-English speakers
* Patients who have cold urticaria
* Patients with bilateral fractures
* Patients currently intubated

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No