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Active, Not Recruiting

NCT Number: NCT06519929

Analgesic Techniques 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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Opioid Use in oral morphine equivalents (OME)

    Time frame: 72 Hours

    This will include both IV and oral opioids. Opioids given via PCA will also be prospectively recorded and included.

  2. Brief Pain Inventory - current pain subscale (0-10)

    Time frame: 0-72 Hours

    The Brief Pain Inventory (short form) - average of all "current pain" ratings).

Secondary outcomes

  1. Daily opioid use

    Time frame: 30 Days

    The total daily opioid use will be recorded and converted to OMEs. The PDMP will be used to confirm if needed.

  2. Daily opioid Use

    Time frame: 90 Days

    The total daily opioid use will be recorded and converted to OMEs. The PDMP will be used to confirm if needed.

  3. Brief Pain Inventory

    Time frame: Days 1-3

    Average pain (0-10) - this is the average of the "average pain" scores

  4. Brief Pain Inventory

    Time frame: Day 30

    Average pain (0-10)

  5. Brief Pain Inventory

    Time frame: Day 90

    Average pain (0-10)

  6. Vital capacity (mL)

    Time frame: Baseline prior to intervention

    Volume of air expired after a maximal inspiration in mL measured with spirometer

  7. Vital capacity (mL)

    Time frame: Day 1

    Volume of air expired after a maximal inspiration in mL measured with spirometer

  8. Vital capacity (mL)

    Time frame: Day 2

    Volume of air expired after a maximal inspiration in mL measured with spirometer

  9. Vital capacity (mL)

    Time frame: Day 3

    Volume of air expired after a maximal inspiration in mL measured with spirometer

  10. Duke Activity Status Index

    Time frame: Baseline prior to intervention

    Functional status assessment (0-60 with 60 representing the best function)

  11. Short-form 12

    Time frame: Baseline prior to intervention

    Functional status assessment (0-100 with 100 representing best function)

  12. Short-form 12

    Time frame: Day 30

    Functional status assessment (0-100 with 100 representing best function)

  13. Short-form 12

    Time frame: Day 90

    Functional status assessment (0-100 with 100 representing best function)

  14. 3D-CAM/CAM-ICU

    Time frame: Day 1

    Delirium assessment (yes or no)

  15. 3D-CAM/CAM-ICU

    Time frame: Day 2

    Delirium assessment (yes or no)

  16. 3D-CAM/CAM-ICU

    Time frame: Day 3

    Delirium assessment (yes or no)

  17. Respiratory depression

    Time frame: Days 1-3

    Naloxone use

  18. Epidural eligibility

    Time frame: Day 1

    Clinical judgment of physician

  19. RibScore

    Time frame: Day 1

    Score includes: >= 6 ribs fractured, flail chest, bilateral fractures, first rib fracture, >= 3 displaced fractures, fracture in each anatomical area

  20. Presence of perioral numbness

    Time frame: Day 1

    Patient self report

  21. Presence of perioral numbness

    Time frame: Day 2

    Patient self report

  22. Presence of perioral numbness

    Time frame: Day 3

    Patient self report

  23. Presence of tinnitus

    Time frame: Day 1

    Patient self report

  24. Presence of tinnitus

    Time frame: Day 2

    Patient self report

  25. Presence of tinnitus

    Time frame: Day 3

    Patient self report

  26. Presence of metallic taste

    Time frame: Day 1

    Patient self report

  27. Presence of metallic taste

    Time frame: Day 2

    Patient self report

  28. Presence of metallic taste

    Time frame: Day 3

    Patient self report

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study title

A Pilot Study Comparing Three Analgesia Approaches for Rib Fractures

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 25, 2024
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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