Comparing two methods for pain control after shoulder surgery

A Feasibility Randomized Control Comparison of Peripheral Interscalene Catheter to Liposomal Bupivacaine Single Injection for Interscalene Blocks Used in Pain Control for Total Shoulder Arthroplasties

This study is testing whether a new way of delivering pain relief after shoulder surgery works better than the standard method to help patients feel less pain and recover more comfortably.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 56 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: University of Iowa (other)
• Locations: 1 site (Iowa City, Iowa)
• Trial ID: NCT05868330 on ClinicalTrials.gov

What this trial studies

This study compares the effectiveness of an interscalene catheter versus a single injection interscalene block for managing post-operative pain in patients undergoing total shoulder arthroplasties. The research focuses on the use of liposomal bupivacaine, which may provide longer-lasting pain relief compared to traditional methods. By evaluating patient outcomes such as pain levels and satisfaction, the study aims to determine which method offers better recovery experiences and reduces the need for narcotics. The study is conducted at the University of Iowa Hospital and Clinics, targeting patients who meet specific eligibility criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 90 undergoing reverse shoulder replacement surgery who can provide informed consent.

Not a fit: Patients with significant medical conditions, chronic opioid use, or those unable to cooperate during the procedure may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing shoulder surgery, enhancing recovery and reducing opioid use.

How similar studies have performed: Previous studies have shown promise in using regional anesthesia techniques for post-operative pain management, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

Patients who have or are:

1. Orthopedics service patients having reverse shoulder replacement surgery
2. ASA class I, II, or III.
3. Patients at least 18 years old but less than 90 years old.
4. Patients giving informed consent.
5. Non-Emergency Surgery

Exclusion Criteria:

Patients who have or are:

1. An inability to cooperate during the block placement.
2. Patients who do not meet criteria for a regional block: such as those on anti-coagulation,
3. Significant pulmonary disease or allergy to medications used for peripheral nerve blocks (Exparel, Bupivacaine and Ropivacaine)
4. Neuropathy of the planned extremity to block
5. Documented Kidney Failure
6. Documented Liver Failure
7. A lack of or inability to give informed consent.
8. Currently incarcerated.
9. Pregnant
10. Unable to communicate in English
11. Chronic pre-operative opioid use (greater than 20 MME opioid used)
12. Fracture
13. Revision surgery

Where this trial is running

Iowa City, Iowa

• University of Iowa Hospital and Clinics — Iowa City, Iowa, United States (RECRUITING)

Study contacts

• Principal investigator: Melinda Seering, MD — University of Iowa
• Study coordinator: Melinda Seering, MD

Conditions: Post Operative Pain, Anesthesia, Nerve Block, Shoulder Osteoarthritis, Shoulder Replacement, Interscalene block, Peripheral Nerve Catheter, Exparel