Clinical trial

Comparison of Cryoablation of Intercostal Nerves to Erector Spinae Plane Catheters in Patients With Rib Fractures

Name

ANES-2024-32820

Description

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.

Trial arms

Trial start

2024-07-01

Estimated PCD

2026-07-31

Trial end

2027-01-30

Status

Not yet recruiting

Phase

Early phase I

Treatment

Cryoablation

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

Arms:

Cryoablation

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.

Arms:

ESP catheter

Size

Primary endpoint

Maximum pain score on POD (Post Operative Day) 7

7 days post procedure

Opioid Use

30 days post procedure

Functional Pain Scores

30 days post procedure

Number of Patients using opioids at POD 30

30 days post procedure

Length of hospital stay

30 days post procedure

Number of patients returned home by POD 30

30 days post procedure

time to first ambulation

30 days post procedure

number of patients admitted to ICU

30 days post procedure

number of patients that required mechanical ventilation

30 days post procedure

Pulmonary Function Testing.

30 days post procedure

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'The individual doing the outcome assessments will be blinded.', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 48, 'type': 'ESTIMATED'}}

Updated at

2024-05-30

1 organization

2 products

1 indication

Organization

University of Minnesota

Product

Cryoablation

Indication

Rib Fractures

Product

ESP Catheter