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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different methods to manage pain from rib fractures. Participants will join one of three groups: one using an ESP block (a type of nerve block) with ropivacaine, another using lidocaine infusions, and the last receiving standard pain treatment with various painkillers, including opioids. The researchers aim to determine which method most effectively reduces pain and opioid use in the first few days, as well as its impact on breathing and long-term pain. Individuals aged 55 and older with three or more broken ribs on one side who are hospitalized might be suitable for this trial. As a Phase 4 trial, this study involves treatments already FDA-approved and proven effective, aiming to understand how they can benefit more patients.

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 is the safety track record for these treatments?

Previous studies have shown promising safety results when using the Erector Spinae Plane (ESP) block with a catheter and ropivacaine. Research indicates that this method effectively manages pain from rib fractures, reducing pain and improving breathing without serious side effects. For instance, patients have reported better breathing and less pain without experiencing issues like low blood pressure.

Lidocaine, administered as an infusion, is also well-tolerated in controlled amounts. The FDA has approved it for various uses, suggesting it is generally safe. While side effects can occur, they are usually mild and manageable.

Overall, both treatments in the trial have demonstrated good safety records based on past research and FDA approvals, indicating they are generally safe for use in humans with minimal risk of severe side effects. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study's treatments?

Researchers are excited about these treatments because they offer new ways to manage pain from rib fractures. The ESP block with catheter using ropivacaine is unique because it provides continuous pain relief directly at the site of injury, potentially reducing the need for opioids, which can have significant side effects. On the other hand, the use of lidocaine as a bolus and infusion offers a systemic pain relief alternative with a different mechanism, acting as an anesthetic by blocking nerve signals throughout the body. These treatments aim to enhance pain management while minimizing reliance on standard care options like opioids and multimodal analgesia.

What evidence suggests that this trial's treatments could be effective for rib fractures?

In this trial, participants will receive one of the following treatments for rib fracture pain: the erector spinae plane (ESP) block with ropivacaine or lidocaine infusions. Research has shown that the ESP block with ropivacaine effectively reduces pain from broken ribs, lowering pain levels by about 21% and aiding in breathing without affecting blood pressure. It also reduces the need for opioids, offering a significant advantage. Meanwhile, lidocaine infusions provide quick pain relief and are often used for their numbing effect. Both treatments in this trial aim to manage pain effectively after rib injuries. ^{4 6 7 8 9}

Who Is on the Research Team?

Eric Schwenk, MD

Principal Investigator

Thomas Jefferson University

Are You a Good Fit for This Trial?

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

Pregnancy

I am allergic to certain local anesthetics or study drugs.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

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

Group III: Standard care with multimodal analgesia and opioids 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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10275321/

Erector Spinae Plane Block as an Analgesic Intervention in ... Six studies reported pain scores 24 to 48 hours post block, maintaining an average reduction of 21% from pre block baseline, while a further ...

2. associationofanaesthetists-publications.onlinelibrary.wiley.com associationofanaesthetists-publications.onlinelibrary.wiley.com/doi/10.1111/anae.14579

The effect of erector spinae plane block on respiratory and ... Erector spinae plane blocks were associated with improved inspiratory capacity and analgesic outcomes following rib fracture, without haemodynamic instability.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0104001421003614

Continuous erector spinae plane block for analgesia and ... Conclusion. Continuous ESP block provide adequate analgesia with better respiratory functions in patients with multiple rib fractures.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04558281

Continuous Erector Spinae Plane Blocks for Rib Fractures The erector spinae plane block (ESPB) is a nerve block that covers multiple rib fractures with a single injection. This block entails injecting local anesthetic ...

5. wjes.biomedcentral.com wjes.biomedcentral.com/articles/10.1186/s13017-024-00567-2

Erector spinae plane block (ESPB) enhances hemodynamic ... ESPB was shown to enhance intraoperative hemodynamic stability, reduce opioid consumption and decrease postoperative analgesic consumption in patients who ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12550286/

Erector Spinae Plane block with fascial plane catheter for the ... Adults with rib fractures were randomised in a 1:1 ratio to either (i) ESP blockade and catheter, or (ii) placebo ESP blockade and catheter, ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0735675724006971

Continuous regional anesthesia with erector spinae plane ... ESP catheter placement and continuous regional anesthesia by EP is a safe, reasonable adjunct to treat pain from rib fractures.

8. rapm.bmj.com rapm.bmj.com/content/70/Suppl_1/A96

183 A case report of erector spinae plane block ... Conclusions The ESP block both reduced the patients pain symptoms and improved his respiratory function. The patient much preferred the ESP block to the PCA he ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT03540095

Study Details | NCT03540095 | Erector Spinae Plane (ESP ... The primary outcome will be total opioid consumption in the first 3 days of nerve block. Secondary outcomes include highest visual analog pain score (VAS) with ...