UltrasouNd-guided Percutaneous Intercostal Nerve Cryoneurolysis for Analgesia Following Traumatic Rib Fracture

More than 100,000 people a year suffer from traumatic rib fractures. Pain from rib fractures impairs the ability to inspire deeply and cough effectively, predisposing patients to severe, potentially life threatening complications and increased healthcare costs. For many patients, this pain can also persist long after the acute injury has healed, delaying recovery and reducing quality of life.

Current pain interventions, including multimodal analgesia and local anesthetic-based nerve blocks, are useful, but are limited by a short duration of effectiveness, and/or risk of complications. Cryoneurolysis (CN) is a new method to control pain which acts to freeze intercostal nerves (ICNs) associated with fractured ribs using a handheld device. This freezing action causes neurons to undergo Wallerian degeneration distally from the site of ablation and thus exhibit an extended but reversible block.

This study is a single-site, randomized, pilot study to assess the feasibility of recruitment, randomization, and protocol adherence of providing cryoneurolysis for patients with traumatic rib fractures. Secondary data from the pilot trial designed to assess the effectiveness of the intervention (pain scores, opioid usage, etc.) will be included in the analysis of the full trial if feasible. The objective of the full trial is to demonstrate that cryoneurolysis of ICN, in addition to standard analgesic practice, provides superior, prolonged analgesia.

Participants (individuals aged 18-85, with 3-8 unilateral traumatic rib fractures) will be randomized 1:1 in blocks of 4, stratified by number of rib fractures (\> 4 or ≤4) and the presence/absence of flail segment, to receive the current standard of practice for rib fractures (multimodal analgesia and erector spinae plane (ESP) catheter infusion) with or without the addition of CN. Participants in the standard care group will receive a sham CN procedure to maintain blinding.

All participants (both groups) will receive standard of care analgesia. Specifically, an ultrasound-guided ESP catheter will be placed as per standard protocols. 20cc of 0.5% ropivacaine and 1% lidocaine will be injected through the catheter, followed by a basal infusion of 2 cc/hr of 0.2% ropivacaine (to maintain catheter patency) with an on demand patient controlled regional anesthesia (PCRA) dose of 10cc 0.2% ropivacaine available hourly until patient has met criteria for APS discharge or pain is controlled such that PCRA use is \< 2 boluses over 12 hrs and NRS \< 3 with deep breathing and coughing.

Standard multimodal analgesia including Tylenol 1000mg QID, Celebrex 200mg BID (or ketorolac 7.5 QID), Pregabalin 50mg BID, and/or PRN oral hydromorphone (1-4mg) will also be provided. Additional analgesics include intravenous ketamine at a dose of 0.1-0.2 mg/kg/hr of lean body weight in the event of consistent NRS pain scores \> 6, and up to 0.05 mg/kg of intravenous midazolam for anxiolysis and 1mcg/kg of intravenous fentanyl for comfort during positioning, as required.

Participants will remain in the study for 3 months from the date of the block procedure. They will be followed daily while in hospital and using a pain diary following discharge (weekly pain scores and daily opioid usage). Additionally, follow-ups will be completed at 1h, 24h, 48h, 1 week, 1 month, and 3 months post block procedure.

• Pain Severity during deep inspiration 24 hours post ESP catheter placement [Срок оценки: 24 hours post placement of ESP catheter]
• Time to discontinuation of ESP catheter [Срок оценки: Until ESP catheter removal (usually < 7 days)]
• ESP catheter use [Срок оценки: Until ESP catheter removal (usually < 7 days)]
• Opioid consumption in hospital and after discharge [Срок оценки: Daily for 90 days after block placement]
• Pain Intensity at 1 and 3 months [Срок оценки: 1 and 3 month follow-ups]
• Oxygen requirements [Срок оценки: Pre-intervention, post intervention, then daily until discharge]
• Pulmonary Function Testing [Срок оценки: Pre-intervention, post intervention, then daily until discharge]
• Pulmonary Function Testing [Срок оценки: Pre-intervention, post intervention, then daily until discharge]
• Pulmonary Function Testing [Срок оценки: Pre-intervention, post intervention, then daily until discharge]
• Pulmonary Function Testing [Срок оценки: Pre-intervention, post intervention, then daily until discharge]
• Length of Stay in hospital [Срок оценки: Date of admission to date discharge]
• Length of Stay on acute pain service (APS) [Срок оценки: Date of admission to date of discharge from acute pain service]