Analgesic Techniques for Rib Fractures
NCT Number: NCT06519929
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Rib Fractures
Interventions: PROCEDURE: ESP block with catheter using ropivacaine (bolus followed by continuous infusion)|DRUG: Lidocaine bolus (1 mg/kg) and infusion starting at 1 mg/kg/h
Sponsor: Thomas Jefferson University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-08
Locations: Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, 19107, United States

Summary:
This study will be a 3-arm, parallel-group, randomized controlled trial comparing three analgesic techniques for rib fractures with a sample size of 24 patients (8 per group). Patients will be randomly assigned to one of the following three groups: 1) ESP block with catheter using ropivacaine (bolus followed by continuous infusion); 2) lidocaine bolus (1 mg/kg) and infusion starting at 1 mg/kg/h; or 3) standard care with multimodal analgesia and opioids.

Our specific aims are:

1. To compare the opioid use and pain ratings over the first 72 hours after enrollment.
2. To quantify the changes in vital capacity, oxygen requirement, and freedom from mechanical ventilation that result from the intervention.
3. To explore the impact of ESP blocks and lidocaine infusions on the development of chronic pain and post-discharge opioid use (exploratory).

Inclusion Criteria:

• Adult patients ≥ 55 years old who have sustained 3 or more unilateral rib fractures and are admitted to the hospital.

Exclusion Criteria:

* Allergy to amide local anesthetics, lidocaine, or ropivacaine
* Pregnancy
* Bilateral rib fractures
* Coagulopathy (INR \> 1.5; PTT \> 1.5 times ULN, or platelets \< 75,000)
* Conduction block on EKG
* Total body weight \< 40 kg
* Painful distracting injuries: acute thoracic spine fracture, severe traumatic brain injury or spinal cord injury, unstable pelvic fracture, open abdomen
* Spine fracture at the level of intended ESP block
* Infection near the ESP insertion site or active bacteremia or sepsis
* Any patient deemed a poor candidate for ESP block and/or lidocaine infusion will also be excluded

Primary Outcome Measures: Opioid Use in oral morphine equivalents (OME), This will include both IV and oral opioids. Opioids given via PCA will also be prospectively recorded and included., 72 Hours|Brief Pain Inventory - current pain subscale (0-10), The Brief Pain Inventory (short form) - average of all "current pain" ratings)., 0-72 Hours
Secondary Outcome Measures: Daily opioid use, The total daily opioid use will be recorded and converted to OMEs. The PDMP will be used to confirm if needed., 30 Days|Daily opioid Use, The total daily opioid use will be recorded and converted to OMEs. The PDMP will be used to confirm if needed., 90 Days|Brief Pain Inventory, Average pain (0-10) - this is the average of the "average pain" scores, Days 1-3|Brief Pain Inventory, Average pain (0-10), Day 30|Brief Pain Inventory, Average pain (0-10), Day 90|Vital capacity (mL), Volume of air expired after a maximal inspiration in mL measured with spirometer, Baseline prior to intervention|Vital capacity (mL), Volume of air expired after a maximal inspiration in mL measured with spirometer, Day 1|Vital capacity (mL), Volume of air expired after a maximal inspiration in mL measured with spirometer, Day 2|Vital capacity (mL), Volume of air expired after a maximal inspiration in mL measured with spirometer, Day 3|Duke Activity Status Index, Functional status assessment (0-60 with 60 representing the best function), Baseline prior to intervention|Short-form 12, Functional status assessment (0-100 with 100 representing best function), Baseline prior to intervention|Short-form 12, Functional status assessment (0-100 with 100 representing best function), Day 30|Short-form 12, Functional status assessment (0-100 with 100 representing best function), Day 90|3D-CAM/CAM-ICU, Delirium assessment (yes or no), Day 1|3D-CAM/CAM-ICU, Delirium assessment (yes or no), Day 2|3D-CAM/CAM-ICU, Delirium assessment (yes or no), Day 3|Respiratory depression, Naloxone use, Days 1-3|Epidural eligibility, Clinical judgment of physician, Day 1|RibScore, Score includes: \>= 6 ribs fractured, flail chest, bilateral fractures, first rib fracture, \>= 3 displaced fractures, fracture in each anatomical area, Day 1|Presence of perioral numbness, Patient self report, Day 1|Presence of perioral numbness, Patient self report, Day 2|Presence of perioral numbness, Patient self report, Day 3|Presence of tinnitus, Patient self report, Day 1|Presence of tinnitus, Patient self report, Day 2|Presence of tinnitus, Patient self report, Day 3|Presence of metallic taste, Patient self report, Day 1|Presence of metallic taste, Patient self report, Day 2|Presence of metallic taste, Patient self report, Day 3