Analgesic Techniques for Rib Fractures

Phase 4

Recruiting

• Conditions: Rib Fractures
• Interventions: Drug: Lidocaine bolus (1 mg/kg) and infusion starting at 1 mg/kg/h; Procedure: ESP block with catheter using ropivacaine (bolus followed by continuous infusion)

• Registration Number: NCT06519929
• Lead Sponsor: Thomas Jefferson University

Brief 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/...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-07-16
• Study First Submitted QC: 2024-07-19
• Study First Posted: 2024-07-25
• Status Verified: 2024-08
• Study Start: 2024-09-01
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-24
• Primary Completion: 2025-07
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• ≥ 55 years old
• Sustained 3 or more unilateral rib fractures and are admitted to the hospital

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Exclusion Criteria

• Allergy to amide local anesthetics or any study medications
• Pregnancy
• Bilateral rib fractures
• Coagulopathy (INR > 1.5; platelets < 100,000)
• Conduction block on EKG
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine bolus (1 mg/kg) and infusion starting at 1 mg/kg/h	Lidocaine bolus (1 mg/kg) and infusion starting at 1 mg/kg/h	-
ESP block with catheter using ropivacaine (bolus followed by continuous infusion)	ESP block with catheter using ropivacaine (bolus followed by continuous infusion)	-

Primary Outcome Measures

Name	Time	Method
Opioid Use in oral morphine equivalents (OME)	72 Hours	This will include both IV and oral opioids. Opioids given via PCA will also be prospectively recorded and included.
Brief Pain Inventory - current pain subscale (0-10)	0-72 Hours	The Brief Pain Inventory (short form) - average of all "current pain" ratings).

Secondary Outcome Measures

Name	Time	Method
Brief Pain Inventory	Day 90	Average pain (0-10)
Daily opioid use	30 Days	The total daily opioid use will be recorded and converted to OMEs. The PDMP will be used to confirm if needed.
Daily opioid Use	90 Days	The total daily opioid use will be recorded and converted to OMEs. The PDMP will be used to confirm if needed.
Vital capacity (mL)	Day 3	Volume of air expired after a maximal inspiration in mL measured with spirometer
Duke Activity Status Index	Baseline prior to intervention	Functional status assessment (0-60 with 60 representing the best function)
Short-form 12	Day 90	Functional status assessment (0-100 with 100 representing best function)
Respiratory depression	Days 1-3	Naloxone use
Epidural eligibility	Day 1	Clinical judgment of physician
3D-CAM/CAM-ICU	Day 3	Delirium assessment (yes or no)
Presence of perioral numbness	Day 3	Patient self report
Presence of metallic taste	Day 3	Patient self report
RibScore	Day 1	Score includes: \>= 6 ribs fractured, flail chest, bilateral fractures, first rib fracture, \>= 3 displaced fractures, fracture in each anatomical area
Presence of tinnitus	Day 3	Patient self report

Trial Locations

Locations (1)

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States