Pain, PostoperativeNCT05415384
Randomized Control Trial, Cryoablation as an Adjunct to Surgical Stabilization of Rib Fractures
A study testing Cryoablation of Intercostal Nerves and Standard surgical treatment of patients with multiple rib fractures in people with Pain, Postoperative and Rib Fracture Multiple, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Postoperative, Rib Fracture Multiple
- What is being tested?
- Cryoablation of Intercostal Nerves and Standard surgical treatment of patients with multiple rib fractures
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Bradley W Thomas, MD, 704-355-3176, Bradley.Thomas@wfusm.edu
About this study
Official title: Single Center, Randomized Control Trial of Cryoablation During Surgical Stabilization of Rib Fractures
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
Read the 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
- Being tested
- Cryoablation of Intercostal Nerves, Standard surgical treatment of patients with multiple rib fractures
- Keywords
- Locoregional pain, thoracotomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryoablation of Intercostal NervesDevice
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 fracturesProcedure or surgery
Standard surgical treatment of patients with multiple rib fractures
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Procedure: Standard surgical treatment of patients with multiple rib fractures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 90
Secondary outcomes (7)
Number of days in Hospital Stay
Hospital Length of Stay
Measured: Days during admission
Number of days in ICU Stay
ICU Length of Stay
Measured: Day 90
Amount of Chest tube drainage
Chest tube drainage
Measured: Day 90
Quality of Life Scores
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
Measured: Month 1 and Month 3
Number of Mortalities in hospital
Mortality, in hospital
Measured: Day 90
Number of Readmissions
Readmission
Measured: 30 day readmission rate
Number of Additional Thoracic Procedures
Additional Thoracic Procedures
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start1 Aug 2022
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 fixation
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bradely W. Thomas, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415384
- Sponsor's protocol ID
- IRB00084611
- Status last verified
- Mar 2026
- First submitted
- 6 Jun 2022
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center, Randomized Control Trial of Cryoablation During Surgical Stabilization of Rib Fractures
- ClinicalTrials.gov ID
- NCT05415384
- Acronym / sponsor ID
- IRB00084611
- Conditions
- Pain, Postoperative, Rib Fracture Multiple
- Keywords
- Locoregional pain, thoracotomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 13 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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 fixation
| Arm | Type | Receives |
|---|---|---|
| Surgical Stabilization of Rib Fractures plus Multimodal Pain Therapy plus CRYOABLATION | Experimental | Device: Cryoablation of Intercostal NervesAdding 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 | Active comparator | Procedure: Standard surgical treatment of patients with multiple rib fracturesStandard surgical treatment of patients with multiple rib fractures plus Multimodal Pain Therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryoablation of Intercostal NervesUsing 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. | Device | Surgical Stabilization of Rib Fractures plus Multimodal Pain Therapy plus CRYOABLATION |
| Standard surgical treatment of patients with multiple rib fracturesStandard surgical treatment of patients with multiple rib fractures | Procedure or surgery | Surgical Stabilization of Rib Fractures plus Multimodal Pain Therapy |
Primary outcome
Morphine Milligram Equivalents Use following Intervention
Time frame: Baseline
To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.
Morphine Milligram Equivalents Use following Intervention
Time frame: Day 1
To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.
Morphine Milligram Equivalents Use following Intervention
Time frame: Day 30
To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.
Morphine Milligram Equivalents Use following Intervention
Time frame: Day 90
To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.
7 secondary outcomes
Number of days in Hospital Stay
Time frame: Days during admission
Number of days in ICU Stay
Time frame: Day 90
Amount of Chest tube drainage
Time frame: Day 90
Quality of Life Scores
Time frame: Month 1 and Month 3
Number of Mortalities in hospital
Time frame: Day 90
Number of Readmissions
Time frame: 30 day readmission rate
Number of Additional Thoracic Procedures
Time frame: Day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bradely W. Thomas, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoablation of Intercostal Nerves and Standard surgical treatment of patients with multiple rib fractures in people with Pain, Postoperative and Rib Fracture Multiple, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bradely W Thomas, MD (704-355-3176, Bradley.Thomas@wfusm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine Milligram Equivalents Use following Intervention (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.