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

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05415384
• Collaborator: (none)
• Enrollment: 80
• Arms: 2
• Anticipated Duration (Months): 13

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative; Rib Fracture Multiple	Device: Cryoablation of Intercostal Nerves; Procedure: Standard surgical treatment of patients with multiple rib fractures	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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 fixationThe 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
• Masking: Single (Participant)
• Masking Description: The study will blind patients to whether or not they underwent cryoneurolysis
• Primary Purpose: Treatment
• Official Title: Single Center, Randomized Control Trial of Cryoablation During Surgical Stabilization of Rib Fractures
• Anticipated Study Start Date: Aug 1, 2022
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.	Device: 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.
Active Comparator: Surgical Stabilization of Rib Fractures plus Multimodal Pain Therapy Standard surgical treatment of patients with multiple rib fractures plus Multimodal Pain Therapy	Procedure: Standard surgical treatment of patients with multiple rib fractures; Standard surgical treatment of patients with multiple rib fractures

Outcome Measures

Primary Outcome Measures

1. Morphine Milligram Equivalents Use following Intervention [Baseline]

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

2. Morphine Milligram Equivalents Use following Intervention [Day 1]

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

3. Morphine Milligram Equivalents Use following Intervention [Day 30]

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

4. 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

1. Number of days in Hospital Stay [Days during admission]

   Hospital Length of Stay

2. Number of days in ICU Stay [Day 90]

   ICU Length of Stay

3. Amount of Chest tube drainage [Day 90]

   Chest tube drainage

4. 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

5. Number of Mortalities in hospital [Day 90]

   Mortality, in hospital

6. Number of Readmissions [30 day readmission rate]

   Readmission

7. Number of Additional Thoracic Procedures [Day 7]

   Additional Thoracic Procedures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 <72 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Wake Forest University Health Sciences

Investigators

• Principal Investigator: Bradely W. Thomas, MD, Wake Forest University Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT05415384
• Other Study ID Numbers: IRB00084611
• First Posted: Jun 13, 2022
• Last Update Posted: Aug 2, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Wake Forest University Health Sciences: Locoregional pain; thoracotomy
• Additional relevant MeSH terms: Pain, Postoperative; Fractures, Bone; Rib Fractures; Fractures, Multiple

Study Results

No Results Posted as of Aug 2, 2022