A Phase 4 interventional study of ESP block with catheter using ropivacaine (bolus followed by continuous infusion) and Lidocaine bolus (1 mg/kg) and infusion starting at 1 mg/kg/h in Rib Fractures, sponsored by Thomas Jefferson University. Active, not recruiting at 1 site in United States. Open to participants aged 55 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-09.
Sponsored by Thomas Jefferson University · Phase 4, Interventional, and Treatment
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:
Inclusion Criteria:
Exclusion Criteria:
131 studies on the registry are indexed under Rib Fractures; 27 are open to participants now.
This study's planned enrollment of 24 is below the median of 60 across 99 interventional studies indexed under Rib Fractures.
Browse Rib Fractures studies →Thomas Jefferson University is the lead sponsor of 384 studies on the registry; 71 are open to participants now.
Of its 44 completed or terminated interventional studies of FDA-regulated products, 20 (45%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
A total of ropivacaine 75mg will be injected into the plane via the needle, followed by placement of a catheter 3-5 cm into the plane. A continuous infusion of ropivacaine 0.2% will be started at 8 mL/h and may be titrated up to a maximum of 10mL/h. Bolus doses of 5 mL using ropivacaine 0.2% will be permitted for breakthrough pain (pain score ≥ 7/10) and may be administered no more frequently than every 6 hours. Patients will be assessed for LAST twice daily by asking about tinnitus, perioral numbness, or metallic taste. Any patient who responds positively to these symptoms will have infusion stopped for 2 h and then restarted at a rate 2 mL/h lower. If the symptoms occur again, the catheter infusion will be stopped and the catheter removed. After the 72-hour study period the ESP catheter may remain in place if the patient has ongoing analgesia needs or if analgesia is controlled with oral medication the catheter may be removed at request of the treating team.
A bolus of 1 mg/kg based on ideal body weight will be given over 10 minutes with a physician present and infusions will be started at 1 mg/kg/h based on IBW. Infusions will run continuously for the first 72 h and can be continued beyond that at the discretion of the treating team if pain persists. Patients will be assessed for LAST twice daily. Any patient with suspected LAST will have lidocaine infusion stopped and a lidocaine plasma level will be sent. If symptoms resolve, the lidocaine infusion can be restarted at a rate 25% lower. If pain is refractory to the lidocaine infusion and multimodal adjuncts, the infusion may be increased to a maximum of 1.5 mg/kg/h (during first 24 h only). The actual duration of the infusion as well as total lidocaine dose given in mg will be recorded. Stopping criteria for lidocaine will include the occurrence of new EKG changes for which an alternative explanation is not more likely as well as LAST symptoms.
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.
Time frame: 72 Hours
Brief Pain Inventory - current pain subscale (0-10)
The Brief Pain Inventory (short form) - average of all "current pain" ratings).
Time frame: 0-72 Hours
Daily opioid use
The total daily opioid use will be recorded and converted to OMEs. The PDMP will be used to confirm if needed.
Time frame: 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.
Time frame: 90 Days
Brief Pain Inventory
Average pain (0-10) - this is the average of the "average pain" scores
Time frame: Days 1-3
Brief Pain Inventory
Average pain (0-10)
Time frame: Day 30
Brief Pain Inventory
Average pain (0-10)
Time frame: Day 90
Vital capacity (mL)
Volume of air expired after a maximal inspiration in mL measured with spirometer
Time frame: Baseline prior to intervention
Vital capacity (mL)
Volume of air expired after a maximal inspiration in mL measured with spirometer
Time frame: Day 1
Vital capacity (mL)
Volume of air expired after a maximal inspiration in mL measured with spirometer
Time frame: Day 2
Vital capacity (mL)
Volume of air expired after a maximal inspiration in mL measured with spirometer
Time frame: Day 3
Duke Activity Status Index
Functional status assessment (0-60 with 60 representing the best function)
Time frame: Baseline prior to intervention
Short-form 12
Functional status assessment (0-100 with 100 representing best function)
Time frame: Baseline prior to intervention
Short-form 12
Functional status assessment (0-100 with 100 representing best function)
Time frame: Day 30
Short-form 12
Functional status assessment (0-100 with 100 representing best function)
Time frame: Day 90
3D-CAM/CAM-ICU
Delirium assessment (yes or no)
Time frame: Day 1
3D-CAM/CAM-ICU
Delirium assessment (yes or no)
Time frame: Day 2
3D-CAM/CAM-ICU
Delirium assessment (yes or no)
Time frame: Day 3
Respiratory depression
Naloxone use
Time frame: Days 1-3
Epidural eligibility
Clinical judgment of physician
Time frame: Day 1
RibScore
Score includes: \>= 6 ribs fractured, flail chest, bilateral fractures, first rib fracture, \>= 3 displaced fractures, fracture in each anatomical area
Time frame: Day 1
Presence of perioral numbness
Patient self report
Time frame: Day 1
Presence of perioral numbness
Patient self report
Time frame: Day 2
Presence of perioral numbness
Patient self report
Time frame: Day 3
Presence of tinnitus
Patient self report
Time frame: Day 1
Presence of tinnitus
Patient self report
Time frame: Day 2
Presence of tinnitus
Patient self report
Time frame: Day 3
Presence of metallic taste
Patient self report
Time frame: Day 1
Presence of metallic taste
Patient self report
Time frame: Day 2
Presence of metallic taste
Patient self report
Time frame: Day 3
Plan to share: No
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