Analgesic Techniques for Rib Fractures

A Pilot Study Comparing Three Analgesia Approaches for Rib Fractures

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

Study Overview

• Status: Active, not recruiting
• Conditions: Rib Fractures
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ESP block with catheter using ropivacaine (bolus followed by continuous infusion)	Procedure: ESP block with catheter using ropivacaine (bolus followed by continuous infusion); 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.
Active Comparator: Lidocaine bolus (1 mg/kg) and infusion starting at 1 mg/kg/h	Drug: Lidocaine bolus (1 mg/kg) and infusion starting at 1 mg/kg/h; 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.
No Intervention: Standard care with multimodal analgesia and opioids

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Investigators: Principal Investigator: Eric Schwenk, MD, Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2024
• Primary Completion (Actual): August 31, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: July 16, 2024
• First Submitted That Met QC Criteria: July 19, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Estimated): September 9, 2025
• Last Update Submitted That Met QC Criteria: September 2, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Thoracic Injuries; Rib Fractures; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Ropivacaine; Lidocaine
• Other Study ID Numbers: IRISID-2022-1186

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No