Randomized Control Trial, Cryoablation as an Adjunct to Surgical Stabilization of Rib Fractures

Wake Forest University (WFU)

Status: Enrolling

Conditions: Rib Fracture Multiple; Pain, Postoperative

Treatments: Device: Cryoablation of Intercostal Nerves; Procedure: Standard surgical treatment of patients with multiple rib fractures

Study type: Interventional

Funder types: Other

Identifiers

NCT05415384

IRB00084611

Details and patient eligibility

About

To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of Surgical Stabilization of Rib Fractures (SSRF) without cryoablation

Full description

Locoregional pain control with cryoneurolysis of intercostal nerves has been employed as an adjunct for longer term pain control. Initially introduced in thoracic surgery, intercostal nerve cryoablation has demonstrated adequate pain control and substantial decrease in opioid consumption and hospital length of stay.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient is admitted to the trauma service.
• The patient has multiple displaced rib fractures (≥2 ribs), offered fixation, and consents to SSRF
• The patient is not being treated for chronic pain
• The patient is >18 years of age.
• Surgery anticipated <120 hours from injury

Exclusion criteria

• Age < 18 years or ≥ 80 years
• Flail chest: either radiographic or clinical. Radiographic flail chest is defined on CT chest as ≥ 2 ribs each fractured in ≥ 2 places. Clinical flail is defined as visualization of a segment of chest wall with paradoxical motion on physical exam.
• Moderate or severe traumatic brain injury (Intra-cranial hemorrhage visualized on CT head with GCS at the time of consideration for enrollment < 12)
• Prior or expected emergency exploratory laparotomy during this admission
• Prior or expected emergency thoracotomy during this admission
• Prior or expected emergency craniotomy during this admission
• Spinal cord injury
• Pelvic fracture that has required, or is expected to require, operative intervention during this admission
• The patient was unable to accomplish activities of daily living independently prior to injury (e.g., dressing, bathing, preparing meals)
• The patient is incarcerated
• The patient is known to be pregnant
• Unable to perform Video Assisted Thoracoscopy (VATS) at time of SSRF due to lung isolation or previous pathology

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Surgical Stabilization of Rib Fractures plus Multimodal Pain Therapy plus CRYOABLATION

Experimental group

Description:

Adding Cryoablation of levels 3-8, in addition to patients that undergo SSRF for multiple rib fractures.

Treatment:

Device: Cryoablation of Intercostal Nerves

Surgical Stabilization of Rib Fractures plus Multimodal Pain Therapy

Active Comparator group

Description:

Standard surgical treatment of patients with multiple rib fractures plus Multimodal Pain Therapy

Treatment:

Procedure: Standard surgical treatment of patients with multiple rib fractures