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

NCT05415384 | Recruiting DMC FDA Device

• 1 other identifier: IRB00084611
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Pain, Postoperative; Rib Fracture Multiple

Keywords

Locoregional pain; thoracotomy

Outcome Measures

Primary Outcomes (4)

• Morphine Milligram Equivalents Use following Intervention

  To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.

  Baseline

• Morphine Milligram Equivalents Use following Intervention

  To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.

  Day 1

• Morphine Milligram Equivalents Use following Intervention

  To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.

  Day 30

• Morphine Milligram Equivalents Use following Intervention

  To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.

  Day 90

Secondary Outcomes (7)

• Number of days in Hospital Stay

  Days during admission

• Number of days in ICU Stay

  Day 90

• Amount of Chest tube drainage

  Day 90

• Quality of Life Scores

  Month 1 and Month 3

• Number of Mortalities in hospital

  Day 90

Study Arms (2)

Surgical Stabilization of Rib Fractures plus Multimodal Pain Therapy plus CRYOABLATION

EXPERIMENTAL

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

Device: Cryoablation of Intercostal Nerves

Surgical Stabilization of Rib Fractures plus Multimodal Pain Therapy

ACTIVE COMPARATOR

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

Procedure: Standard surgical treatment of patients with multiple rib fractures

Interventions

Cryoablation of Intercostal Nerves 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 plus CRYOABLATION

Standard surgical treatment of patients with multiple rib fractures PROCEDURE

Standard surgical treatment of patients with multiple rib fractures

Surgical Stabilization of Rib Fractures plus Multimodal Pain Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Bradely W. Thomas, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bradely W Thomas, MD

CONTACT

704-355-3176; Bradley.Thomas@wfusm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The study will blind patients to whether or not they underwent cryoneurolysis
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The proposed study is a single center, prospective, randomized controlled trial evaluating the efficacy of adding cryoneurolysis for patients that meet indication for Surgical Stabilization of Rib Fractures (SSRF) and consent to surgical fixation

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 13, 2022
• Study Start: August 1, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)