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

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT05415384
Status
Recruiting
Apply to this trial

Conditions

  • Pain, Postoperative
  • Rib Fracture Multiple

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

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.
  • Standard surgical treatment of patients with multiple rib fractures — PROCEDURE
    Standard surgical treatment of patients with multiple rib fractures

Study Details

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

Key Dates

Start date
Aug 1, 2022
Status verified
Mar 2026
Primary completion
Jun 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

Morphine Milligram Equivalents Use following Intervention [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157
Bradley W Thomas, MD
[email protected]
704-355-3176

Find similar trials in Winston-Salem, NC

By research site
Wake Forest University Health Sciences· Winston-Salem, NC

Related Studies