Pain Clinical Trial
— UNPINOfficial title:
UltrasouNd-guided Percutaneous Intercostal Nerve Cryoneurolysis for Analgesia Following Traumatic Rib Fracture, a Pilot Randomized Control Trial (UNPIN Trial)
NCT number | NCT05865327 |
Other study ID # | 5715 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 23, 2023 |
Est. completion date | December 2025 |
Traumatic rib fractures (i.e., broken ribs caused by a physical injury) are common and very painful. They also often lead to serious complications, more time spent in hospital, and can even lead to death. Even after rib fractures have healed, they can lead to long-term pain and a lower quality of life. A technology called cryoneurolysis, which acts to freeze nerves causing pain using a small tool which can turn very cold, is a promising new way to manage rib fracture pain. This study is a test with a small number of people to see if it is feasible to use this technology for patients with rib fractures. If this is successful, we will recruit more people for a larger study to see if cryoneurolysis, along with standard pain control techniques, is better at stopping pain, compared to just the normal techniques alone. Participants in our study will be asked to rate their pain, and record pain medications that they take for 3 months after their pain procedure.
Status | Recruiting |
Enrollment | 24 |
Est. completion date | December 2025 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - Aged =18 - Unilateral traumatic rib fractures (3 to 8) - Candidate for ESP block catheter - Within 48hrs of admission to hospital Exclusion Criteria: - Lack of patient consent; unlikely to comply with follow up - Unable to use Patient Controlled Regional Analgesia (Ventilated/sedated patients or Moderate to severe traumatic brain injury) - Chronic pain (opioid use > 30mg oral morphine equivalent per day) - Substance use disorder - CrCl < 50 - BMI > 45 - Significant distracting injuries (unreduced long bone fractures, unstable pelvic or spine fractures and patients requiring trauma laparotomy- also preclude positioning for block placement (lateral decubitus or sitting up)) - Contraindications for ESP catheter placement (pre-existing medical/neurological/hematologic diseases, localized infection/trauma at site of intervention, allergy to amide local anesthetics) - Contraindications to CN (cryoglobulinemia, paroxysmal cold hemoglobinuria, multiple myeloma and cold urticarial). - Unable to return to Trauma Recovery Clinic (in-person or virtual) at 3 months |
Country | Name | City | State |
---|---|---|---|
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Sunnybrook Health Sciences Centre |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Pain Intensity | As measured using NRS-11, at rest and during deep inspiration | 1h and 48h, post block placement, daily in hospital, weekly post discharge and at 1 week follow-up | |
Primary | Number of participants randomized over an 8 month period | Goal of 3 participants per month for 8 months | Entire pilot study (approximately 8 months) | |
Primary | Number of participants able to adhere to the protocol | Goal of > 90% | Entire pilot study (approximately 8 months + 3 month follow-up) | |
Primary | Number of participants able to adhere to the follow-up | Goal of > 90% | 3 month follow-up | |
Primary | Rate of Adverse events | Ensure no adverse events (short or long term) associated with CN | 3 month follow-up | |
Secondary | Pain Severity during deep inspiration 24 hours post ESP catheter placement | Pain measured using Numeric Pain Rating Scale | 24 hours post placement of ESP catheter | |
Secondary | Time to discontinuation of ESP catheter | Based on when 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 | Until ESP catheter removal (usually < 7 days) | |
Secondary | ESP catheter use | Cumulative volume of local anesthetic solution used via ESP catheter patient controlled reginal analgesia | Until ESP catheter removal (usually < 7 days) | |
Secondary | Opioid consumption in hospital and after discharge | Determined from medical records (in-hospital) and via a daily pain diary (post-discharge). Calculated in Oral Morphine Equivalents. | Daily for 90 days after block placement | |
Secondary | Pain Intensity at 1 and 3 months | As measured using Numeric Pain Rating Scale (0-10) , at rest and during deep inspiration | 1 and 3 month follow-ups | |
Secondary | Oxygen requirements | Room air oxygen saturation (SpO2) and requirement for supplementary O2 to maintain SpO2 > 92% | Pre-intervention, post intervention, then daily until discharge | |
Secondary | Pulmonary Function Testing | FVC | Pre-intervention, post intervention, then daily until discharge | |
Secondary | Pulmonary Function Testing | FEV1 | Pre-intervention, post intervention, then daily until discharge | |
Secondary | Pulmonary Function Testing | Peak Inspiratory flow | Pre-intervention, post intervention, then daily until discharge | |
Secondary | Pulmonary Function Testing | Peak Expiratory Flow | Pre-intervention, post intervention, then daily until discharge | |
Secondary | Length of Stay in hospital | Hospital discharge date | Date of admission to date discharge | |
Secondary | Length of Stay on acute pain service (APS) | Criteria include on oral meds without continuous regional analgesia or intravenous opioids | Date of admission to date of discharge from acute pain service | |
Secondary | Time to achieve discharge criteria for isolated chest injury | Criteria include on oral meds without continuous regional analgesia, chest tube out and chest well evacuated (e.g. no evidence of retained hemothorax), and no supplemental O2 | Date of admission until discharge criteria met | |
Secondary | Patient satisfaction | Patient satisfaction assessed using Patients' Global Impression of Change (PGIC) scale | 48 post block procedure, and 1 week, 1 month and 3 month follow-ups | |
Secondary | Incidence of chronic rib fracture pain | As assessed using Brief Pain Inventory (BPI) questionnaire | 3 month follow-up | |
Secondary | Adverse events | Adverse events to be recorded include: local anesthetic complications, catheter related complications (clotting, migration), procedural complications (pneumothorax, bleeding, infection), and neurological disturbances (dysesthesia, hyperalgesia, allodynia) in area of rib fracture | until 3 month follow-up |
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