RecruitingPhase 4NCT05868330

Comparison of Interscalene Catheter to Single Injection Interscalene Blocks for Total Shoulder Arthroplasties

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


Sponsor

Melinda Seering

Enrollment

56 participants

Start Date

Aug 19, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria6

  • Patients who have or are:
  • Orthopedics service patients having reverse shoulder replacement surgery
  • ASA class I, II, or III.
  • Patients at least 18 years old but less than 90 years old.
  • Patients giving informed consent.
  • Non-Emergency Surgery

Exclusion Criteria14

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

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Interventions

PROCEDUREInterscalene Catheter

Pre-operatively the patient will have a interscalene catheter placed by a regional skilled anesthesiologist. The initial block will be with 20 cc of 0.5% Bupivacaine and maintained on an infusion post-operatively at 8cc/hr of 0.2% ropivacaine as is our intuitions protocol

PROCEDUREExparel Single Shot Interscalene Block

Pre-operatively the patient will have a interscalene single shot block with 133 mg Liposomal Bupivacaine and 10 ccs 0.5% Bupivacaine placed by a regional skilled anesthesiologist.


Locations(1)

University of Iowa Hospital and Clinics

Iowa City, Iowa, United States

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NCT05868330


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