Recruiting

Cryoablation

Sponsor:

Wake Forest University Health Sciences

Code:

NCT05415384

Conditions

Pain, Postoperative

Rib Fracture Multiple

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Cryoablation of Intercostal Nerves

Standard surgical treatment of patients with multiple rib fractures

Study Details

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

Study ID

NCT05415384

Start date

Aug 1, 2022

Status verified date

Mar, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: Surgical Stabilization of Rib Fractures plus Multimodal Pain Therapy

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

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.

Standard surgical treatment of patients with multiple rib fractures

Standard surgical treatment of patients with multiple rib fractures

Primary outcome measure

  • Morphine Milligram Equivalents Use following Intervention [ Time Frame: Baseline ]
  • Morphine Milligram Equivalents Use following Intervention [ Time Frame: Day 1 ]
  • Morphine Milligram Equivalents Use following Intervention [ Time Frame: Day 30 ]
  • Morphine Milligram Equivalents Use following Intervention [ Time Frame: Day 90 ]

Central Contacts and Locations

Central contacts

Bradely W Thomas, MD

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

Locations

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Bradley W Thomas, MD

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

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jun 29, 2026

Last verified

Mar, 2026

Keywords

  • Locoregional pain
  • thoracotomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-06-29.