Interscalene Catheter vs. Single Shot Block for Postoperative Shoulder Pain

Overseen By Melinda Seering, MD

Age: 18+

Sex: Any

Trial Phase: Academic

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)

Compensation: Varies

Number of Visits: 9

Duration: 1 day

56 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Exparel Single Shot Interscalene Block, Interscalene Catheter for postoperative shoulder pain?

Research shows that the interscalene block, especially when used with a catheter for continuous pain relief, is highly effective in managing pain after shoulder surgery. It is considered the best technique for pain relief at rest and during movement, compared to other methods. ^{1 2 3 4 5}

Is the interscalene block safe for managing postoperative shoulder pain?

The interscalene block is generally considered safe for managing postoperative shoulder pain, but it can cause hemidiaphragmatic paresis (temporary partial paralysis of the diaphragm), which is a risk for people with serious lung problems. Continuous interscalene block is effective for pain relief, but like any medical procedure, it should be monitored for complications. ^{1 2 3 6 7}

How does the Exparel Single Shot Interscalene Block treatment differ from other treatments for postoperative shoulder pain?

The Exparel Single Shot Interscalene Block is unique because it provides effective early pain control with a single injection, which can be extended with a catheter for longer-lasting relief. This approach minimizes the need for opioids, which can have unwanted side effects, and is particularly beneficial for patients who need to avoid systemic medications. ^{1 2 3 6 7}

What is the purpose of this trial?

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

Research Team

Melinda Seering, MD

Principal Investigator

University of Iowa

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Anaesthesia for shoulder surgery. [2022]

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

Evaluation of the lateral modified approach for continuous interscalene block after shoulder surgery. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Postoperative analgesia for shoulder surgery. [2019]

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

Will the Real Benefits of Single-Shot Interscalene Block Please Stand Up? A Systematic Review and Meta-Analysis. [2022]

5. England 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. [2022]

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

Suprascapular and Interscalene Nerve Block for Shoulder Surgery: A Systematic Review and Meta-analysis. [2018]

7. Belgium pubmed.ncbi.nlm.nih.gov

Continuous interscalene block using a stimulating catheter: a review of the technique. [2005]