Interscalene Catheter vs. Single Shot Block for Postoperative Shoulder Pain

Overseen By Melinda Seering, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Melinda Seering

Must not be taking: Anticoagulants, Opioids

Disqualifiers: Pulmonary disease, Kidney failure, 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: 9

Duration: 1 day

56 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on finding the best way to manage pain after shoulder replacement surgery. Researchers compare two methods: an Exparel Single Shot Interscalene Block (a local anesthetic injection) and an Interscalene Catheter (a continuous pain relief method). Both methods are used before surgery to help control pain. People planning to have reverse shoulder replacement surgery, without significant lung issues or allergies to certain medications, might be a good fit. As an unphased trial, this study offers patients the chance to contribute to important research that could enhance post-surgical pain management techniques.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on anti-coagulation medication, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Exparel, when used in a single-shot interscalene block, relieves pain and reduces the need for opioids after shoulder surgery. The FDA approved it for this use in 2018, indicating its general safety. Studies have found that patients using Exparel experience fewer complications compared to traditional methods.

For the interscalene catheter, research indicates it provides excellent pain relief with low pain scores after surgery. However, some reports mention problems around the catheter site. Despite this, it usually offers effective pain management.

Both treatments are widely used and well-regarded for managing pain after shoulder surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for postoperative shoulder pain because they offer potentially improved pain management options. The Exparel Single Shot Interscalene Block uses a long-acting local anesthetic, which may provide extended pain relief from just one injection, reducing the need for continuous medication and minimizing hospital stays. On the other hand, the Interscalene Catheter involves placing a small tube for a continuous supply of anesthetic, which can offer consistent pain control but may come with the hassle of managing the catheter. By comparing these two methods, researchers hope to identify a more effective and convenient option for patients recovering from shoulder surgery.

What evidence suggests that this trial's treatments could be effective for postoperative shoulder pain?

This trial will compare the effectiveness of two treatments for postoperative shoulder pain: the Exparel Single Shot Interscalene Block and the Interscalene Catheter. Research has shown that Exparel, a long-lasting pain medication, reduces pain after shoulder surgery. The FDA approved it for this use in 2018, and studies indicate that it manages pain and decreases the need for opioids post-surgery. In contrast, the Interscalene Catheter is often considered the best option for managing pain after shoulder surgery. It provides longer-lasting relief by continuously delivering pain medication, lasting up to 48 hours post-surgery. Both treatments aim to effectively control pain, but they operate in slightly different ways. ^{1 2 6 7 8}

Who Is on the Research Team?

Melinda Seering, MD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

This trial is for adults aged 18-89 undergoing reverse shoulder replacement surgery who can give informed consent and are not on anticoagulants, without significant lung disease, kidney or liver failure, neuropathy in the affected limb, chronic opioid use over 20 MME, fractures, revision surgeries or an inability to cooperate during block placement.

Inclusion Criteria

My health is good to moderately impaired.

My upcoming surgery is not an emergency.

Patients giving informed consent

Exclusion Criteria

I have nerve pain or damage in the limb where the procedure is planned.

I cannot communicate in English.

I do not have severe lung problems or allergies to specific nerve block medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative

Patients complete pre-operative assessments including the ASES questionnaire and PROMIS measures

1 day

1 visit (in-person)

Treatment

Participants receive either an interscalene catheter or a single shot interscalene block with Exparel for pain control during shoulder arthroplasty

1 day

1 visit (in-person)

Post-operative Recovery

Participants recover in the Post-operative Care Unit (PACU) and are monitored for pain and opioid use

23 hours

Follow-up

Participants are monitored for pain scores and functional status at various intervals post-surgery

3 months

Surveys at 7 days, 14 days, 30 days, and 90 days

What Are the Treatments Tested in This Trial?

Interventions

• Exparel Single Shot Interscalene Block
• Interscalene Catheter

Trial Overview

The study compares two types of pain management after shoulder surgery: one group receives a continuous interscalene catheter delivering medication while the other gets a single injection called Exparel. The goal is to see which method better controls post-operative pain.

How Is the Trial Designed?

Group I: Interscalene Catheter Active Control 1 Intervention

One of the current standard of care for shoulder replacement surgery at our institution is to receive an interscalene catheter for pre-operatively

Group II: Exparel Single Shot Interscalene Block Active Control 1 Intervention

One of the current standard of care for shoulder replacement surgery at our institution is to receive a pre-operative single shot interscalene block with Exparel

Who Is Running the Clinical Trial?

Melinda Seering

Lead Sponsor

Trials

3

Recruited

250+

Published Research Related to This Trial

A continuous interscalene block is an effective method for managing postoperative pain after major shoulder surgery, providing significant pain relief.

The article reviews the stimulating catheter technique for this block, detailing the authors' experience with the first 200 catheters placed, indicating a practical application of the technique in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous interscalene block using a stimulating catheter: a review of the technique. van de Putte, P., van der Vorst, M.[2005]

In a meta-analysis of 16 studies involving 1,152 patients, both interscalene and suprascapular blocks showed similar effectiveness in reducing postoperative pain and opioid consumption after shoulder surgery, with no clinically meaningful differences in analgesic outcomes.

While interscalene block provided slightly better pain control during recovery, suprascapular block was associated with fewer block-related and respiratory complications, suggesting it may be a safer alternative for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suprascapular and Interscalene Nerve Block for Shoulder Surgery: A Systematic Review and Meta-analysis. Hussain, N., Goldar, G., Ragina, N., et al.[2018]

Interscalene block (ISB) provides effective pain relief for up to 8 hours at rest and 6 hours with motion after shoulder surgery, but patients may experience rebound pain at 24 hours, leading to similar pain levels as those who did not receive ISB.

ISB significantly reduces opioid consumption and related side effects in the first 12 to 24 hours post-surgery, making it a valuable option for managing postoperative pain while minimizing opioid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Will the Real Benefits of Single-Shot Interscalene Block Please Stand Up? A Systematic Review and Meta-Analysis. Abdallah, FW., Halpern, SH., Aoyama, K., et al.[2022]

The modified lateral approach for interscalene catheter placement in 700 patients resulted in a high success rate for anesthesia (97%) and effective postoperative pain relief (99%), indicating its efficacy for shoulder surgery.

The study reported low rates of complications, with only 0.7% experiencing local infections and minor neurologic issues observed in 2.4% of patients, while patient satisfaction averaged 9.6 out of 10, highlighting the safety and acceptability of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the lateral modified approach for continuous interscalene block after shoulder surgery. Borgeat, A., Dullenkopf, A., Ekatodramis, G., et al.[2019]

The modified lateral technique for interscalene block is highlighted as the safest and most effective method for pain control after major shoulder surgery, facilitating early rehabilitation.

Continuous infusion of local anesthetics through an interscalene catheter provides superior pain relief both at rest and during movement, making it the best technique for managing postoperative pain in shoulder surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anaesthesia for shoulder surgery. Borgeat, A., Ekatodramis, G.[2022]

The anterior suprascapular nerve block (SSNB) provided slightly better pain control than the interscalene brachial plexus block (ISB) after shoulder surgery, with a mean pain level 0.32 units lower, while still being noninferior in effectiveness.

SSNB resulted in significantly less grip strength impairment, with 99% of patients maintaining unimpaired grip strength compared to only 49% in the ISB group, making SSNB a safer and more effective option for postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anterior Suprascapular Nerve Block Versus Interscalene Brachial Plexus Block for Shoulder Surgery in the Outpatient Setting: A Randomized Controlled Patient- and Assessor-Blinded Trial. Wiegel, M., Moriggl, B., Schwarzkopf, P., et al.[2022]

Both arthroscopic and open shoulder surgeries lead to significant postoperative pain, and a multi-modal approach to pain management is recommended to reduce opioid use and its side effects.

Interscalene block provides effective pain relief for shoulder surgery but carries a risk of hemidiaphragmatic paresis, especially in patients with serious lung issues; continuous interscalene block may be beneficial for more invasive procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative analgesia for shoulder surgery. Desai, N.[2019]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7231813/

Single-shot liposomal bupivacaine interscalene block ...

Interscalene nerve blocks have been shown to improve postoperative pain and reduce opioid use in the early postoperative period in patients ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2059775423005825

Liposomal bupivacaine interscalene blocks demonstrate a ...

Liposomal bupivacaine was FDA approved for use in patients undergoing single shot interscalene block in 2018 to reduce postoperative pain from shoulder surgery ...

3.

jshoulderelbow.org

jshoulderelbow.org/article/S1058-2746(24)00868-1/abstract

Randomized clinical trial comparing mixed liposomal ...

The purpose of this investigation was to examine the analgesic efficacy, quality of recovery, and treatment costs between interscalene nerve ...

4.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/13/NCT03827213/Prot_SAP_000.pdf

2018-9707 irb approval date

The purpose of the study we are proposing is to determine if single shot interscalene nerve blocks using Exparel can provide equivalent or better analgesia than ...

5.

trialx.com

trialx.com/clinical-trials/listings/304314/comparison-of-interscalene-catheter-to-single-injection-interscalene-blocks-for-total-shoulder-arthroplasties/

Comparison of Interscalene Catheter to Single Injection ...

Overview. Comparison of post-operative pain after total shoulder surgery. The Principle Investigator will be comparing Exparel single shot ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06139666

The Effect of Liposomal Bupivacaine Nerve Block (Exparel) ...

The goal of this clinical trial is to investigate if there is a difference in pain after an arthroscopic rotator cuff surgery when a nerve block is performed ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36115616/

Nerve block with liposomal bupivacaine yields fewer ...

Patients receiving liposomal bupivacaine experienced fewer complications than traditional ISCs after arthroscopic shoulder surgery.

8.

jshoulderelbow.org

jshoulderelbow.org/article/S1058-2746(16)30674-7/fulltext

A prospective randomized trial to identify the optimal ...

Patients in Group 1 received a continuous interscalane peripheral nerve block (CISB) with 0.125% bupivacaine at a rate of 6 ml/hour postoperatively. Patients in ...