Pain Relief Techniques for Rib Fractures

Overseen By George Koenig, DO

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Thomas Jefferson University

Must not be taking: Amide anesthetics

Disqualifiers: Pregnancy, Bilateral rib fractures, Coagulopathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 72 hours

24 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment ESP block with catheter using ropivacaine for rib fractures?

Research shows that the Erector Spinae Plane (ESP) block, when used with catheters, can effectively relieve pain in patients with rib fractures, improving their breathing and reducing the need for respiratory support. This technique has been successfully used in cases where other pain management methods were not suitable, providing a simpler and less invasive option for pain relief. ^{1 2 3 4 5}

Is the ESP block with ropivacaine or lidocaine safe for humans?

The ESP block is considered relatively safe and noninvasive, providing effective pain relief for conditions like rib fractures and thoracic surgery, with no major safety concerns reported in the studies. ^{1 3 4 6 7}

How is the ESP block treatment for rib fractures different from other treatments?

The ESP block treatment for rib fractures is unique because it uses a regional anesthetic technique that can be administered even when other methods are not possible due to spine injuries or blood clotting issues. It is simple to perform with ultrasound guidance, making it suitable for use in intensive care settings, and it can be managed in outpatient settings with a better safety profile. ^{1 3 5 8 9}

Research Team

Eric Schwenk, MD

Principal Investigator

Thomas Jefferson University

Eligibility Criteria

This trial is for adults over 55 with at least three rib fractures on one side, admitted to the hospital. They can't join if they're allergic to certain anesthetics, pregnant, have bilateral rib fractures, blood clotting issues, heart conduction problems, weigh under 40 kg or have other severe injuries or infections that could interfere.

Inclusion Criteria

I am 55 years old or older.

I have three or more broken ribs on one side and am hospitalized.

Exclusion Criteria

I am allergic to certain local anesthetics or study drugs.

Pregnancy

Coagulopathy (INR > 1.5; platelets < 100,000)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants are randomly assigned to one of three analgesic techniques for rib fractures: ESP block with ropivacaine, lidocaine bolus and infusion, or standard care with multimodal analgesia and opioids

72 hours

Continuous monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness, including opioid use and pain ratings, and the development of chronic pain and post-discharge opioid use

90 days

Regular follow-up visits and assessments

Treatment Details

Interventions

• ESP block with catheter using ropivacaine
• Lidocaine

Trial Overview The study compares three pain management methods for rib fractures: ESP block with ropivacaine infusion; lidocaine bolus and infusion; versus standard care including opioids. It aims to assess opioid use, pain levels, lung function improvements and potential reduction in chronic pain or long-term opioid need.

Participant Groups

Group I: ESP block with catheter using ropivacaine (bolus followed by continuous infusion) Experimental Treatment 1 Intervention

Group II: Standard care with multimodal analgesia and opioids Active Control 1 Intervention

Group III: Lidocaine bolus (1 mg/kg) and infusion starting at 1 mg/kg/h Active Control 1 Intervention

ESP block with catheter using ropivacaine is already approved in United States, European Union for the following indications:

Approved in United States as Erector Spinae Plane Block for:

• Rib fractures
• Thoracic pain management

Approved in European Union as Erector Spinae Plane Block for:

• Rib fractures
• Thoracic pain management

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Findings from Research

Erector spinae plane (ESP) blocks can effectively manage pain in trauma patients with acute rib and spine fractures, providing a viable alternative when traditional neuraxial techniques are contraindicated.

In a case study of a patient with bilateral rib and spine fractures, the use of bilateral ESP catheters significantly improved pain control and allowed for weaning off respiratory support, highlighting their potential in surgical and trauma analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective Analgesia with Bilateral Erector Spinae Plane Catheters for a Patient with Traumatic Rib and Spine Fractures. Klesius, L., Schroeder, K.[2020]

The erector spinae plane (ESP) block is a safe and effective technique for providing thoracic analgesia, as demonstrated in a case report involving three patients undergoing thoracic surgery.

Using ultrasound guidance for the ESP block reduces the risk of complications compared to more invasive procedures, making it a preferable option for postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Erector Spinae Plane Block Catheter Insertion under Ultrasound Guidance for Thoracic Surgery: Case Series of Three Patients. Ince, I., Ozmen, O., Aksoy, M., et al.[2020]

The erector spinae plane (ESP) block is an effective alternative for pain relief in patients with acute rib fractures, which is important for preventing pulmonary complications.

This case report introduces the use of unilateral bilevel ESP catheters for a patient with flail chest, suggesting a novel approach to enhance analgesia in severe rib injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unilateral Bilevel Erector Spinae Plane Catheters for Flail Chest: A Case Report. Liu, R., Clark, L., Bautista, A.[2021]

The ultrasound-guided erector spinae plane (ESP) block is a simple and noninvasive technique for providing effective thoracic pain relief, making it a good alternative to traditional thoracic epidural analgesia.

In a case report, the ESP block was successfully used as a rescue method for post-thoracotomy pain management in a patient who did not respond to epidural analgesia, highlighting its potential effectiveness in challenging situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Erector Spinae Plane Block for Rescue Analgesia in Thoracotomy After Epidural Failure: A Case Report. Forero, M., Rajarathinam, M., Adhikary, S., et al.[2022]

In a study of 80 patients with multiple rib fractures, the Retrolaminar Block (RLB) provided significantly better pain relief compared to the Erector Spinae Plane Block (ESPB), as evidenced by lower intraoperative remifentanil and postoperative morphine usage.

Patients receiving RLB reported lower pain scores at multiple time points after surgery and showed better respiratory function, indicating that RLB is a more effective analgesic technique for managing pain in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of erector spinae plane block and retrolaminar block on analgesia for multiple rib fractures: a randomized, double-blinded clinical trial. Zhao, Y., Tao, Y., Zheng, S., et al.[2022]

In a case series of 10 patients undergoing bilateral erector spinae plane (ESP) block for lumbar spine surgery, lidocaine showed a rapid absorption with peak concentrations (Cmax) ranging from 1.2 to 3.8 mg/L, which remained below toxicity limits.

The pharmacokinetics of lidocaine after ESP block indicated high bioavailability (average AUC0-3 of 76%) and a slightly prolonged elimination half-life in older patients, suggesting that age may influence drug metabolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of lidocaine after bilateral ESP block. De Cassai, A., Bonanno, C., Padrini, R., et al.[2021]

In a study of 60 patients undergoing lumbar spinal surgery, those who received bilateral ultrasound-guided erector spinae plane block (ESPB) with ropivacaine reported significantly lower postoperative pain levels (NRS 1.9) compared to those who received local infiltration (NRS 5.9).

Patients in the ESPB group also required less opioid medication and had a shorter hospital stay, with 73.3% discharged within 72 hours compared to 100% in the control group, indicating that ESPB is a more effective analgesic technique for this type of surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral lumbar ultrasound-guided erector spinae plane block versus local anesthetic infiltration for perioperative analgesia in lumbar spine surgery: a randomized controlled trial. Vergari, A., Frassanito, L., DI Muro, M., et al.[2022]

The ultrasound-guided erector spinae plane block (ESP) is an effective and simple method for managing pain in patients with rib fractures, which can help prevent complications like atelectasis and pneumonia.

In a case study, the ESP block successfully managed pain in a patient with multiple rib fractures in the ICU, demonstrating its potential for improving patient outcomes in critical care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain Management for Traumatic Rib Fractures with ESP Block in ICU. Gursoy, C., Kuscu, Y., Demirbilek, SG.[2021]

The continuous erector spinae plane block was effective in improving pain control and incentive spirometry in a 72-year-old man with multiple rib fractures, suggesting its utility as a regional anesthesia technique for managing rib fracture pain.

However, the technique had limitations, as the patient ultimately required a thoracic epidural catheter for effective pain management and to prevent respiratory failure, highlighting the need for careful consideration of anesthesia options in complex trauma cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thoracic Epidural as a Rescue Analgesic in a Patient with a Continuous Erector Spinae Plane Block for Rib Fractures: A Case Report. Coblentz, IJ., Ilfeld, BM., Finneran Iv, JJ.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effective Analgesia with Bilateral Erector Spinae Plane Catheters for a Patient with Traumatic Rib and Spine Fractures. [2020]

2. Turkey pubmed.ncbi.nlm.nih.gov

Erector Spinae Plane Block Catheter Insertion under Ultrasound Guidance for Thoracic Surgery: Case Series of Three Patients. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Unilateral Bilevel Erector Spinae Plane Catheters for Flail Chest: A Case Report. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Continuous Erector Spinae Plane Block for Rescue Analgesia in Thoracotomy After Epidural Failure: A Case Report. [2022]

5. Brazil pubmed.ncbi.nlm.nih.gov

Effects of erector spinae plane block and retrolaminar block on analgesia for multiple rib fractures: a randomized, double-blinded clinical trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of lidocaine after bilateral ESP block. [2021]

7. Italy pubmed.ncbi.nlm.nih.gov

Bilateral lumbar ultrasound-guided erector spinae plane block versus local anesthetic infiltration for perioperative analgesia in lumbar spine surgery: a randomized controlled trial. [2022]

8. Pakistan pubmed.ncbi.nlm.nih.gov

Pain Management for Traumatic Rib Fractures with ESP Block in ICU. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Thoracic Epidural as a Rescue Analgesic in a Patient with a Continuous Erector Spinae Plane Block for Rib Fractures: A Case Report. [2023]