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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether adding a pectoserratus block (a type of nerve block) to the standard interscalene block can better manage pain and reduce opioid use after shoulder replacement surgery. This procedure might cover more areas affected during surgery, potentially lowering pain and opioid use. It suits adults undergoing total or reverse shoulder replacement surgery, excluding those with severe lung issues or existing nerve damage. Participants will be randomly assigned to receive either bupivacaine (a numbing medication) or saline as part of the pectoserratus block. As a Phase 4 trial, this study involves an FDA-approved treatment and aims to understand its benefits for more patients.

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 is the safety track record for the Interscalene Block and Pectoserratus Block treatments?

Research has shown that both the interscalene block (ISB) and the pectoserratus block are generally safe for individuals undergoing shoulder surgery. Studies have found that ISB effectively manages shoulder pain and is well-tolerated, even in patients with other health conditions.

The pectoserratus block is often used to relieve pain after chest or rib surgeries. Patients have reported pain relief with few side effects, indicating its safety for shoulder surgery as well.

Overall, both treatments maintain a strong safety record, with no major issues reported in the studies. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

The Pectoserratus Block combined with the Interscalene Block is unique because it offers a potentially enhanced method of pain management for shoulder surgery, which is commonly addressed with general anesthesia and opioid medications. Unlike traditional options that often rely heavily on opioids, this technique uses a local anesthetic approach, which can reduce the risk of opioid-related side effects and improve recovery times. Researchers are particularly excited about the possibility of providing effective pain relief with less reliance on narcotics, potentially leading to better patient outcomes and a smoother post-surgery experience.

What evidence suggests that the addition of a pectoserratus block to an interscalene block could be effective for improving pain control and reducing opioid use in shoulder surgery?

Research has shown that the interscalene block (ISB) effectively relieves pain in shoulder surgeries and is considered the best method for reducing pain and limiting opioid use. However, it does not relieve pain in all areas affected by total shoulder replacement surgery. In this trial, some participants will receive the pectoserratus block in addition to the ISB. The pectoserratus block can help by covering more areas affected by the surgery. Studies have demonstrated that adding the pectoserratus block can further reduce pain and decrease the need for opioids. This combination aims to provide better pain management for patients undergoing total shoulder replacement. ^{1 2 4 5 6}

Who Is on the Research Team?

Jacob Hutchins, MD, MHA

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8067774/

Safety and Cost-Effectiveness of Interscalene Brachial Plexus ... This retrospective study included 15 patients with symptomatic rotator cuff arthropathy who underwent reverse total shoulder arthroplasty (rTSA) ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9902626/

Recent updates on interscalene brachial plexus block for ... Interscalene brachial plexus block (ISBPB) provides optimal analgesia for shoulder surgery. However, several limitations still exist.

3. mayo.edu mayo.edu/research/clinical-trials/cls-20239340

A Study of the Pain Control Effectiveness of Interscalene ... The purpose of this study is to compare the effectiveness of pain control between a single shot interscalene brachial plexus nerve block, a continuous ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2059775423005825

Liposomal bupivacaine interscalene blocks demonstrate a ... We hypothesized that the addition of liposomal bupivacaine to interscalene blocks would demonstrate an increase in the proportion of total shoulder arthroplasty ...

5. aoj.amegroups.org aoj.amegroups.org/article/view/9312/html

An update on regional anesthesia in shoulder surgery In shoulder surgery, the most notable regional anesthesia techniques are interscalene brachial plexus block (ISB), supraclavicular brachial ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04415931?tab=table

Local Infiltration Analgesia Vs. Interscalene Block in Total ... The purpose of the proposed study is to determine the efficacy and safety of local infiltration analgesia in shoulder arthroplasty in comparison to interscalene ...