Analgesic Techniques for Rib Fractures

NCT06519929 | Active Not Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: IRISID-2022-1186
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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/kg) and infusion starting at 1 mg/kg/h; or 3) standard care with multimodal analgesia and opioids. Our specific aims are:

• 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

Conditions

Rib Fractures

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (28)

• Daily opioid use

  30 Days

• Daily opioid Use

  90 Days

• Brief Pain Inventory

  Days 1-3

• Brief Pain Inventory

  Day 30

• Brief Pain Inventory

  Day 90

Study Arms (3)

ESP block with catheter using ropivacaine (bolus followed by continuous infusion)

EXPERIMENTAL

Procedure: ESP block with catheter using ropivacaine (bolus followed by continuous infusion)

Lidocaine bolus (1 mg/kg) and infusion starting at 1 mg/kg/h

ACTIVE COMPARATOR

Drug: Lidocaine bolus (1 mg/kg) and infusion starting at 1 mg/kg/h

Standard care with multimodal analgesia and opioids

NO INTERVENTION

Interventions

ESP block with catheter using ropivacaine (bolus followed by continuous infusion) PROCEDURE

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.

ESP block with catheter using ropivacaine (bolus followed by continuous infusion)

Lidocaine bolus (1 mg/kg) and infusion starting at 1 mg/kg/h DRUG

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.

Lidocaine bolus (1 mg/kg) and infusion starting at 1 mg/kg/h

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Rib Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries

Study Officials

• Eric Schwenk, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants, care providers, and investigators will not be blinded but outcome assessors will be unaware of group assignment when doing baseline assessments and when performing some post-randomization assessments, such as those at 30 and 90 days by phone call.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3-arm, parallel-group, randomized controlled trial

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 25, 2024
• Study Start: September 23, 2024
• Primary Completion: August 31, 2025
• Study Completion: December 1, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)