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

Not Applicable

Recruiting

• Conditions: Pain, Postoperative; Rib Fracture Multiple
• Interventions: Device: Cryoablation of Intercostal Nerves; Procedure: Standard surgical treatment of patients with multiple rib fractures

• Registration Number: NCT05415384
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study First Submitted: 2022-06-06
• Study First Submitted QC: 2022-06-08
• Study First Posted: 2022-06-13
• Study Start: 2022-08-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-03-30
• Primary Completion: 2026-06
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical Stabilization of Rib Fractures plus Multimodal Pain Therapy plus CRYOABLATION	Cryoablation of Intercostal Nerves	Adding Cryoablation of levels 3-8, in addition to patients that undergo SSRF for multiple rib fractures.
Surgical Stabilization of Rib Fractures plus Multimodal Pain Therapy	Standard surgical treatment of patients with multiple rib fractures	Standard surgical treatment of patients with multiple rib fractures plus Multimodal Pain Therapy

Primary Outcome Measures

Name	Time	Method
Morphine Milligram Equivalents Use following Intervention	Day 90	To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.

Secondary Outcome Measures

Name	Time	Method
Number of days in ICU Stay	Day 90	ICU Length of Stay
Amount of Chest tube drainage	Day 90	Chest tube drainage
Quality of Life Scores	Month 1 and Month 3	Quality of Life questionnaire - Quality of life questionnaire consists of a set of survey questions that can be used to collect data related to an individual in particular and society in general on various parameters that determine their general quality of life
Number of days in Hospital Stay	Days during admission	Hospital Length of Stay
Number of Mortalities in hospital	Day 90	Mortality, in hospital
Number of Readmissions	30 day readmission rate	Readmission
Number of Additional Thoracic Procedures	Day 7	Additional Thoracic Procedures

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States