Pectoserratus Block + Interscalene Block for Shoulder Surgery

Overseen By Candace Nelson

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Minnesota

Must not be taking: Opioids

Disqualifiers: Nerve damage, Severe lung disease, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

110 Participants Needed

Trial Summary

What is the purpose of this trial?

The use of ISB in patients undergoing total shoulder arthroplasty (TSA) is the gold standard and results in significantly reduced pain scores and opioid use. However, patients still have pain and the majority require opioids postoperatively as the interscalene block (ISB) doesn't cover all of the dermatomes impacted during TSA. A pectoserratus block typically provides coverage to additional dermatomes that are impacted during TSA. Currently ISB is performed for every patient and perform a pectoserratus block to a portion of our patients undergoing TSA. The purpose of the study is to determine if the addition of the pectoserratus block to the ISB will results in improvement in pain control and decrease in opioid use, among patients undergoing TSA. This is a randomized prospective controlled trial. All patients undergoing total shoulder arthroplasty or reverse total shoulder arthroplasty aged 18-85 will be considered eligible for the study. Participants will be randomized to one of 2 treatment groups. Group 1 will receive an ultrasound guided pectoserratus block with 25 mL of 0.25% bupivacaine. Group 2 will be the control and receive an ultrasound guided pectoserratus block with 25 mL of saline. The drug will be administered by the anesthesiologist in-charge of the participant's care or an anesthesiologist who is a part of the study team.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude patients who are currently using opioids or have chronic pain.

What data supports the effectiveness of the treatment Pectoserratus Block + Interscalene Block for Shoulder Surgery?

Research shows that the Interscalene Brachial Plexus Block (ISB) is effective for reducing pain and the need for opioids after shoulder surgery, and using ultrasound improves its success and safety. ^{1 2 3 4 5}

Is the Pectoserratus Block + Interscalene Block for shoulder surgery safe?

The Interscalene Block, used in shoulder surgeries, is generally safe but can have side effects like temporary voice changes, low heart rate, low blood pressure, and nerve issues. Most complications are temporary, and using ultrasound guidance can help reduce risks. ^{4 6 7 8 9}

How does the interscalene block treatment differ from other treatments for shoulder surgery?

The interscalene block (ISB) is a regional anesthesia technique that specifically targets the nerves in the neck to provide pain relief for shoulder surgeries, offering an alternative to general anesthesia or intravenous sedatives. It is often combined with a serratus plane block to enhance anesthesia quality, making it unique in its ability to provide targeted pain relief and muscle relaxation without the need for additional analgesia. ^{2 3 10 11 12}

Research Team

Jacob Hutchins, MD, MHA

Principal Investigator

University of Minnesota

Eligibility Criteria

This trial is for patients aged 18-85 undergoing total shoulder replacement surgery. It's suitable for those who can receive an ultrasound-guided block as part of their pain management.

Inclusion Criteria

I am having a total or reverse shoulder replacement surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a pectoserratus block with bupivacaine or saline during total shoulder arthroplasty

1 day

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for pain and opioid use within the first 48 hours post-operation

2 days

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including hospital length of stay and functional pain score

5 days

Treatment Details

Interventions

• Interscalene Block
• Pectoserratus Block

Trial Overview The study tests if adding a pectoserratus block with bupivacaine to the standard interscalene block improves pain control and reduces opioid use after shoulder replacement surgery, compared to using saline.

Participant Groups

Group I: Bupivacaine group Experimental Treatment 1 Intervention

Patients undergoing total shoulder arthroplasty or reverse total shoulderarthroplasty aged 18- 85, randomized to the experimental group.

Group II: control group Placebo Group 1 Intervention

Patients undergoing total shoulder arthroplasty or reverse total shoulderarthroplasty aged 18- 85, randomized to the control group.

Interscalene Block is already approved in United States, European Union, Canada for the following indications:

Approved in United States as ISB for:

• Shoulder surgery
• Total shoulder arthroplasty
• Reverse total shoulder arthroplasty

Approved in European Union as ISB for:

• Shoulder surgery
• Total shoulder arthroplasty
• Reverse total shoulder arthroplasty

Approved in Canada as ISB for:

• Shoulder surgery
• Total shoulder arthroplasty
• Reverse total shoulder arthroplasty

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Findings from Research

Ultrasound-guided interscalene brachial plexus block (ISB) is an effective method for providing anesthesia and pain relief during shoulder and proximal arm surgeries, enhancing recovery after these procedures.

The use of ultrasound technology has significantly increased the success rates of ISB while also reducing the risk of complications associated with the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound guided interscalene brachial plexus block. Serchan, P., Griseto, L., Armissoglio, G., et al.[2023]

In a study of 70 patients undergoing major open-shoulder surgery, the use of a patient-controlled interscalene catheter delivering ropivacaine significantly reduced the need for rescue pain medication in the first 24 hours post-surgery compared to a single-shot block with saline.

Both methods had similar rates of side effects, indicating that the patient-controlled catheter system is a safe and effective option for managing postoperative pain in shoulder surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interscalene brachial plexus block for open-shoulder surgery: a randomized, double-blind, placebo-controlled trial between single-shot anesthesia and patient-controlled catheter system. Goebel, S., Stehle, J., Schwemmer, U., et al.[2022]

In a study of 109 patients undergoing shoulder surgery, ultrasound-guided blocks provided faster onset of anesthesia and greater effectiveness compared to peripheral nerve stimulator-confirmed blocks, which had a higher rate of conversion to general anesthesia due to insufficient block.

The dual guidance technique, combining ultrasound and peripheral nerve stimulation, is recommended as it may reduce complications while maintaining effective anesthesia for shoulder surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, comparative study of the effectiveness of three different techniques of interscalene brachial plexus block using 0.5% ropivacaine for shoulder arthroscopy. Kolny, M., Stasiowski, MJ., Zuber, M., et al.[2019]

A case of bupivacaine toxicity was reported in a 66-year-old man after an interscalene brachial plexus block for rotator cuff surgery, leading to severe bradycardia and hypotension shortly after the procedure.

This incident highlights the importance for emergency physicians to recognize and manage local anesthetic systemic toxicity (LAST), as it can occur despite the generally safe profile of local anesthetics used in regional anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Profound Prolonged Bradycardia and Hypotension after Interscalene Brachial Plexus Block with Bupivacaine. Nelson, M., Reens, A., Reda, L., et al.[2018]

In a study of 78 patients undergoing elective elbow surgery, the interscalene brachial plexus block (ISB) successfully provided anesthesia in 96% of cases, allowing surgeries to be completed without the need for opioids or general anesthesia.

Postoperative pain levels were low, with verbal rating scores ranging from 0 to 2, indicating effective pain management following the ISB procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low interscalene block provides reliable anesthesia for surgery at or about the elbow. Gadsden, JC., Tsai, T., Iwata, T., et al.[2018]

In a study of 133 patients undergoing shoulder surgery, interscalene block (ISB) anesthesia was successful in 98% of cases, demonstrating its efficacy for pain management during ambulatory procedures.

The incidence of neurologic complications after ISB was low at 1.4%, with only two cases of transient neurapraxia and one major complication (a seizure), indicating that ISB is a safe technique when performed by experienced anesthesiologists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interscalene block anesthesia at an ambulatory surgery center performing predominantly regional anesthesia: a prospective study of one hundred thirty-three patients undergoing shoulder surgery. Faryniarz, D., Morelli, C., Coleman, S., et al.[2016]

In a study of 100 patients undergoing major shoulder surgery, interscalene brachial and cervical plexus block anesthesia was successful in 82% of cases, significantly reducing the need for postoperative pain medication.

While the block provided effective anesthesia lasting an average of eight hours, there were some complications, including loss of consciousness and respiratory depression in three patients, highlighting the importance of monitoring anesthetic levels during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interscalene block anesthesia for shoulder surgery. Conn, RA., Cofield, RH., Byer, DE., et al.[2022]

An interscalene brachial plexus block is effective for providing anesthesia and pain relief during shoulder surgery, but it can lead to significant side effects.

In this case, a patient experienced lung atelectasis and pleural effusion, resulting in chest discomfort, highlighting the potential risks associated with this anesthesia technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pleural effusion and atelectasis during continuous interscalene brachial plexus block -A case report-. Yang, CW., Jung, SM., Cho, CK., et al.[2021]

The interscalene block (ISB) is a widely used technique for anesthesia in shoulder surgery, but it carries risks, particularly neurological complications, which are often temporary.

Using ultrasound guidance during ISB can help visualize critical structures and reduce the risk of complications, although nerve stimulation alone does not ensure safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prolonged dysphonia as a complication of interscalene block. Villar, T., Pacreu, S., Zalbidea, M., et al.[2022]

Interscalene brachial plexus block is an effective alternative to general anesthesia for shoulder dislocation reduction, with 14 out of 30 blocks completely abolishing pain and 13 improving it.

The procedure provided sufficient muscle relaxation in 21 patients, allowing for successful dislocation reduction in 26 cases without the need for additional sedation, and it was performed with no significant complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interscalene brachial plexus blocks in the management of shoulder dislocations. Underhill, TJ., Wan, A., Morrice, M.[2019]

Adding a serratus plane block (SPB) to the standard interscalene brachial plexus block (ISBPB) significantly reduces the need for intraoperative sedative and analgesic medications during arthroscopic shoulder surgery, indicating improved anesthesia quality.

While the combination of SPB and ISBPB did not show a difference in postoperative opioid consumption or pain scores, it suggests that SPB enhances the overall effectiveness of anesthesia without increasing postoperative discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does the Serratus Plane Block Added to the Interscalene Block Improve the Quality of Anesthesia in Arthroscopic Shoulder Surgery? A Prospective Randomized Study. Demir, U., Yayik, AM., Köse, M., et al.[2020]

A single injection of local anaesthetic into the interscalene space effectively blocks both the brachial and cervical plexuses, providing pain relief for shoulder surgeries.

The report discusses the benefits and potential complications of using the interscalene block for shoulder operations, highlighting its effectiveness and the need for careful consideration of risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical report: interscalene block for shoulder operations. Lim, EK.[2018]

References

1. Romania pubmed.ncbi.nlm.nih.gov

Ultrasound guided interscalene brachial plexus block. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Interscalene brachial plexus block for open-shoulder surgery: a randomized, double-blind, placebo-controlled trial between single-shot anesthesia and patient-controlled catheter system. [2022]

3. Poland pubmed.ncbi.nlm.nih.gov

Randomized, comparative study of the effectiveness of three different techniques of interscalene brachial plexus block using 0.5% ropivacaine for shoulder arthroscopy. [2019]

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

Profound Prolonged Bradycardia and Hypotension after Interscalene Brachial Plexus Block with Bupivacaine. [2018]

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

Low interscalene block provides reliable anesthesia for surgery at or about the elbow. [2018]

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

Interscalene block anesthesia at an ambulatory surgery center performing predominantly regional anesthesia: a prospective study of one hundred thirty-three patients undergoing shoulder surgery. [2016]

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

Interscalene block anesthesia for shoulder surgery. [2022]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

Pleural effusion and atelectasis during continuous interscalene brachial plexus block -A case report-. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Prolonged dysphonia as a complication of interscalene block. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Interscalene brachial plexus blocks in the management of shoulder dislocations. [2019]

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

Does the Serratus Plane Block Added to the Interscalene Block Improve the Quality of Anesthesia in Arthroscopic Shoulder Surgery? A Prospective Randomized Study. [2020]

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

Clinical report: interscalene block for shoulder operations. [2018]