Nerve Block for Rib Fractures

Overseen By Brent Becker, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: WellSpan Health

Must be taking: IV analgesia, oral opioids

Disqualifiers: Age <18, Allergy to anesthesia, others

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

Compensation: Varies

Number of Visits: 3

Duration: Up to 24 hours

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is a single center, randomized controlled trial examining the effect of serratus anterior plane block (SAPB) on pain, PIC scores and other clinical outcomes in emergency department patients with multiple rib fractures in comparison to the use of analgesic medication alone. Objectives 1. Compare SAPB performed in the ED setting to analgesic medication alone with regard to pain, respiratory status and PIC score of patients with multiple rib fractures. 2. Assess the safety and feasibility of performing ultrasound-guided SAPB in the ED. 3. Evaluate outcomes of patients receiving the SAPB in the ED including amount of analgesic medications used, level of care required, need for upgrading level of care, and length of stay.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on comparing a nerve block to pain medication, so you might continue your current meds, but it's best to confirm with the trial coordinators.

What data supports the effectiveness of the treatment Serratus Anterior Plane Block (SAPB) for rib fractures?

Research shows that the serratus anterior plane block (SAPB) is effective in reducing pain and the need for additional pain medication in patients with rib fractures. It has been successfully used for pain management in similar conditions like breast surgery and thoracic surgeries, indicating its potential effectiveness for rib fracture pain. ^{1 2 3 4 5}

Is the serratus anterior plane block (SAPB) safe for humans?

The serratus anterior plane block (SAPB) is considered a safe method for pain control in patients with rib fractures, as indicated by studies teaching its use to medical residents and its application in various pain management scenarios. ^{1 2 3 4 6}

How is the serratus anterior plane block (SAPB) treatment different from other treatments for rib fractures?

The serratus anterior plane block (SAPB) is unique because it is an ultrasound-guided procedure that provides targeted pain relief by blocking nerves in the chest area, which can reduce the need for other pain medications like opioids. This treatment is particularly beneficial for rib fractures as it can cover a large area of the chest without affecting major blood vessels or nerves. ^{1 2 3 6 7}

Research Team

Daniel Kreider, MD

Principal Investigator

WellSpan Health

Eligibility Criteria

This trial is for adults over 18 with one or more rib fractures confirmed by X-ray or CT scan, who visit WellSpan York Hospital's ED and need IV painkillers or oral opioids. It excludes those under 18, unable to consent, allergic to local anesthesia, needing urgent surgery, discharged immediately, revisiting for the same injury, or with other major injuries.

Inclusion Criteria

I am older than 18 years.

>1 Unilateral, acute rib fractures diagnosed on x-ray or CT imaging

Patient presenting to the WellSpan York Hospital ED

Exclusion Criteria

I have severe injuries that pain medication for the chest wouldn't help.

Inability to provide informed consent

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive either serratus anterior plane block (SAPB) or standard analgesic medications in the emergency department

Up to 24 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain scores and adverse outcomes

30 days

1 phone call at 1 week, electronic medical record review at 30 days

Treatment Details

Interventions

• Serratus Anterior Plane Block (SAPB)
• Standard Analgesic Medications

Trial Overview The study compares a pain relief technique called Serratus Anterior Plane Block (SAPB) guided by ultrasound against standard pain medications in patients with multiple rib fractures. The focus is on pain management effectiveness and overall patient outcomes like medication use and hospital stay length.

Participant Groups

Group I: Serratus Anterior Plane Block Experimental Treatment 2 Interventions

Subjects will undergo serratus anterior plane block, in addition to standard of care analgesic medications at the discretion of the treatment team.

Group II: Standard Analgesic Medications Active Control 1 Intervention

Subjects will receive standard of care analgesic medications at the discretion of the treatment team.

Serratus Anterior Plane Block (SAPB) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Serratus Anterior Plane Block for:

• Rib fractures
• Chest wall pain

Approved in European Union as Serratus Anterior Plane Block for:

• Rib fractures
• Thoracic surgery pain

Approved in Canada as Serratus Anterior Plane Block for:

• Rib fractures
• Chest wall pain

Who Is Running the Clinical Trial?

WellSpan Health

Lead Sponsor

Trials

32

Recruited

2,005,000+

Findings from Research

In a study of 60 patients with rib fractures, the serratus anterior plane block (SAPB) significantly reduced total tramadol consumption and pain scores compared to the control group, indicating its effectiveness in managing acute pain.

Patients receiving SAPB reported lower rates of chronic pain at rest and during activity, suggesting that this technique not only alleviates immediate pain but may also help prevent long-term pain issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesic efficacy of the serratus anterior plane block in rib fractures pain: A randomized controlled trial. Tekşen, Ş., Öksüz, G., Öksüz, H., et al.[2021]

The study successfully trained 28 emergency medicine residents to perform the serratus anterior plane block (SAPB) using a mastery learning approach, with all participants achieving mastery by scoring 17 out of 19 items correctly on a checklist after training.

Residents reported a significant increase in confidence regarding the SAPB procedure, moving from a median score of 2 to 5 on a 5-point scale, indicating that the training effectively improved both skills and self-assurance in performing this pain control technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a Simulated Model and Mastery Learning Approach to Teach the Ultrasound-guided Serratus Anterior Plane Block to Emergency Medicine Residents: A Pilot Study. Rider, AC., Miller, DT., Ashenburg, N., et al.[2022]

The bilateral ultrasound-guided serratus anterior plane block (SAPB) effectively relieved severe pain in a 72-year-old male with deep partial-thickness burns, providing complete pain resolution for about 15 hours.

This case suggests that SAPB can be a valuable part of a multimodal analgesic approach for managing pain in patients with superficial and partial-thickness burns on the anterior chest wall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case Report: Bilateral Ultrasound-guided Serratus Anterior Plane Blocks for a Chest Wall Burn. Benesch, T., Mantuani, D., Nagdev, A.[2021]

In a case series of 10 patients with multiple rib fractures experiencing severe pain, ultrasound-guided serratus anterior plane block (SAPB) significantly reduced pain scores by a median of 5 points within 30 minutes and 7.5 points after 60 minutes.

The technique was safely administered by trained emergency physicians, with no reported block failures or complications, indicating its potential as an effective pain management option for rib fracture patients in the emergency department.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-Guided Serratus Anterior Plane Block for Rib Fracture-Associated Pain Management in Emergency Department. Paul, S., Bhoi, SK., Sinha, TP., et al.[2022]

In a study of 72 patients with multiple rib fractures, those receiving continuous serratus anterior plane block (SAPB) experienced significantly lower pain scores and reduced fentanyl consumption compared to those treated with fentanyl alone.

The use of ultrasound-guided SAPB was found to be safe, with no complications reported, and it offers an effective, opioid-sparing pain management option that can enhance recovery and facilitate early mobilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A retrospective study comparing analgesic efficacy of ultrasound-guided serratus anterior plane block versus intravenous fentanyl infusion in patients with multiple rib fractures. Diwan, S., Nair, A.[2022]

The serratus anterior plane block (SAPB) significantly reduced pain in patients with multiple rib fractures, with mean pain scores decreasing by 1.8 at 15 minutes and 2.5 at 60 minutes after the procedure.

SAPB also improved lung function, as indicated by a mean increase in maximal vital capacity of 232 mL at 60 minutes, and no complications were reported within 24 hours, suggesting it is a safe and effective pain management option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-Guided Serratus Anterior Plane Block (SAPB) Improves Pain Control in Patients With Rib Fractures. Kring, RM., Mackenzie, DC., Wilson, CN., et al.[2022]

The serratus anterior plane block (SAPB) can be safely and efficiently performed in the emergency department for patients with multiple rib fractures, with a median procedure time of just 5.5 minutes and 80% completed in a single attempt.

Patients experienced a significant reduction in pain scores from 6.5 to 3 within 4 hours after the SAPB, and no complications were reported, suggesting that this technique could be a valuable addition to pain management protocols in trauma settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regional anaesthesia for rib fractures: A pilot study of serratus anterior plane block. Schnekenburger, M., Mathew, J., Fitzgerald, M., et al.[2021]

References

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

Analgesic efficacy of the serratus anterior plane block in rib fractures pain: A randomized controlled trial. [2021]

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

Using a Simulated Model and Mastery Learning Approach to Teach the Ultrasound-guided Serratus Anterior Plane Block to Emergency Medicine Residents: A Pilot Study. [2022]

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

Case Report: Bilateral Ultrasound-guided Serratus Anterior Plane Blocks for a Chest Wall Burn. [2021]

4. India pubmed.ncbi.nlm.nih.gov

Ultrasound-Guided Serratus Anterior Plane Block for Rib Fracture-Associated Pain Management in Emergency Department. [2022]

5. India pubmed.ncbi.nlm.nih.gov

A retrospective study comparing analgesic efficacy of ultrasound-guided serratus anterior plane block versus intravenous fentanyl infusion in patients with multiple rib fractures. [2022]

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

Ultrasound-Guided Serratus Anterior Plane Block (SAPB) Improves Pain Control in Patients With Rib Fractures. [2022]

7. Australia pubmed.ncbi.nlm.nih.gov

Regional anaesthesia for rib fractures: A pilot study of serratus anterior plane block. [2021]