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

NCT ID: NCT05415384

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2026-09-30

Brief Summary

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

Detailed 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.

Conditions

Pain, Postoperative; Rib Fracture Multiple

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Surgical Stabilization of Rib Fractures plus Multimodal Pain Therapy plus CRYOABLATION

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

Group Type: EXPERIMENTAL

Cryoablation of Intercostal Nerves

Intervention Type: DEVICE

Using Atricure device, cryoice, intercostal nerves 3-8 will be ablated in the experimental arm. This is in addition to mechanical fixation of rib fractures and multimodal systemic therapy.

Surgical Stabilization of Rib Fractures plus Multimodal Pain Therapy

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

Group Type: ACTIVE_COMPARATOR

Standard surgical treatment of patients with multiple rib fractures

Intervention Type: PROCEDURE

Standard surgical treatment of patients with multiple rib fractures

Interventions

Cryoablation of Intercostal Nerves

Using Atricure device, cryoice, intercostal nerves 3-8 will be ablated in the experimental arm. This is in addition to mechanical fixation of rib fractures and multimodal systemic therapy.

Intervention Type: DEVICE

Standard surgical treatment of patients with multiple rib fractures

Standard surgical treatment of patients with multiple rib fractures

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bradely W. Thomas, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Bradely W Thomas, MD

Role: CONTACT

bwthomas@wakehealth.edu

704-355-3176

Facility Contacts

Bradley W Thomas, MD

Role: primary

bwthomas@wakehealth.edu

704-355-3176

Other Identifiers

IRB00084611

Identifier Type: -

Identifier Source: org_study_id