Actively Recruiting

Phase 4
Age: 18Years - 90Years
All Genders
Healthy Volunteers
ID05868330

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

Led by Melinda Seering · Updated on 2025-11-10

56

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating two methods for managing pain after total shoulder replacement surgery: the use of an interscalene catheter and a single injection interscalene block with liposomal bupivacaine. This study aims to compare these approaches in terms of pain control, opioid use, cost, and patient outcomes, addressing the challenge of managing intense post-operative pain and improving recovery experience. Both methods are standard care options with distinct benefits and potential drawbacks, and this research seeks to identify which offers better results for patients. Participants will be randomly assigned to receive either an interscalene catheter placed pre-operatively by a skilled anesthesiologist, delivering continuous infusion of ropivacaine for 24 to 48 hours, or a single shot interscalene block using liposomal bupivacaine combined with bupivacaine. Both treatments are administered before surgery under anesthesia. The catheter method requires ongoing management of the infusion pump, while the single injection option offers prolonged pain relief through a slow-release anesthetic formulation. The study will assess these approaches during the initial hospital stay and follow patients up to three months after surgery. Throughout the study, participants will complete questionnaires evaluating pain, functionality, and quality of life before surgery and at multiple points up to six months post-operatively. Pain scores and opioid use will be tracked closely in the hospital and after discharge, with researchers also measuring costs and environmental impact related to each technique. The primary outcome is the functional pain score at one day after surgery, with additional assessments at 7, 30, and 90 days. This comprehensive monitoring aims to capture both short-term and longer-term effects of the treatments on recovery and patient satisfaction.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 90Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients scheduled for reverse shoulder replacement surgery
  • ASA class I, II, or III
  • Age between 18 and 90 years
  • Able to give informed consent
  • Non-emergency surgery
Not Eligible

You will not qualify if you...

  • Unable to cooperate during block placement
  • Not eligible for regional block (including those on anticoagulation)
  • Significant pulmonary disease
  • Allergy to Exparel, Bupivacaine, or Ropivacaine
  • Neuropathy in the arm to be blocked
  • Documented kidney failure
  • Documented liver failure
  • Unable or unwilling to give informed consent
  • Currently incarcerated
  • Pregnant
  • Unable to communicate in English
  • Chronic opioid use over 20 MME before surgery
  • Fracture
  • Revision surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 48 hours post-operatively

Participants receive either a pre-operative interscalene catheter with continuous infusion or a single injection interscalene block with liposomal bupivacaine for pain control during shoulder replacement surgery.

1 pre-operative visit and hospital stay for surgery with 23 hours admission

Post-operative Follow-up

Duration - 3 months

Participants complete pain and functional status assessments and report opioid use and complications at several time points following surgery.

Visits or surveys at 7 days, 14 days, 30 days, 2 weeks, 6 weeks, and 3 months post-operatively

Trial Site Locations

Total: 1 location

1

University of Iowa Hospital and Clinics

Iowa City, Iowa, United States, 52242

Actively Recruiting

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Research Team

M

Melinda Seering, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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Published Research Related To This Trial

Single shot interscalene regional anesthesia provides noninferior analgesia and decreased complications compared with an indwelling catheter for arthroscopic and reconstructive shoulder surgery.

Lucas G Teske, Stephan G Pill, Adam Lutz...

https://pubmed.ncbi.nlm.nih.gov/35301140

Interscalene block with liposomal bupivacaine versus continuous interscalene catheter in primary total shoulder arthroplasty.

Jay M Levin, Lefko T Charalambous, Alex Girden...

https://pubmed.ncbi.nlm.nih.gov/35472576

Quality of Recovery After Rotator Cuff Repair With Interscalene Liposomal Bupivacaine Versus Interscalene Nerve Catheter.

Jay W Schoenherr, Michael Gonzalez, Ricardo Serrano...

https://pubmed.ncbi.nlm.nih.gov/36458106

Patient-Reported Outcomes Measurement Information System Scores Are Inconsistently Correlated With Legacy Patient-Reported Outcome Measures in Shoulder Pathology: A Systematic Review.

Robert N Matar, Nihar S Shah, Brian M Grawe

https://pubmed.ncbi.nlm.nih.gov/33253797

Establishing and comparing reference preoperative Patient-Reported Outcomes Measurement Information System (PROMIS) scores in patients undergoing shoulder surgery.

Eric W Guo, Kareem Elhage, Austin G Cross...

https://pubmed.ncbi.nlm.nih.gov/33010435