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

NCT05868330 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 202301485
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post Operative Pain; Anesthesia; Nerve Block; Shoulder Osteoarthritis

Keywords

Nerve Block; Shoulder Replacement; Interscalene block; Peripheral Nerve Catheter; Exparel

Outcome Measures

Primary Outcomes (1)

• Pain Score Assessed by functional pain score at POD 1

  The primary outcome to be assessed is to determine if there is a quantitative difference in post-operative pain scores as a result of the administration of a interscalene Exparel block versus the administration of an interscalene catheter for shoulder replacement surgery. The functional pain scale is a slightly more quantifiable measure of pain used in a diverse adult population to look at functional ability with pain. The Functional Pain Scale incorporates a "0" to "5" scale, with worsening pain being registered by higher numbers.

  The primary outcome will occur at 1 day after surgery date

Secondary Outcomes (14)

• Pain Scores Assessed by functional pain scores on Post-operative day 7

  Seven days after surgery date

• Pain Scores Assessed by functional pain scores on Post-operative day 30

  At 30 days after surgery date

• Pain Scores Assessed by functional pain scores on Post-operative day 90

  At 90 days after surgery date

• Measurement of the narcotics used to control pain (PACU)

  Up to 2 hours in Post-Operative Recovery Unit

• Measurement of the narcotics used to control pain (POD 1)

  At one day after surgery (narcotic use from PACU to 24 hours after surgery)

Study Arms (2)

Interscalene Catheter

ACTIVE COMPARATOR

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

Procedure: Interscalene Catheter

Exparel Single Shot Interscalene Block

ACTIVE COMPARATOR

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

Procedure: Exparel Single Shot Interscalene Block

Interventions

Interscalene Catheter PROCEDURE

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

Interscalene Catheter

Exparel Single Shot Interscalene Block PROCEDURE

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.

Exparel Single Shot Interscalene Block

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Melinda Seering: lead

Study Sites (1)

University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242, United States

RECRUITING

Related Publications (10)

• Teske LG, Pill SG, Lutz A, Thigpen CA, Shanley E, Adams KJ, Bohon H, Graham GD, Marston G, Walker KB, Kissenberth MJ. Single shot interscalene regional anesthesia provides noninferior analgesia and decreased complications compared with an indwelling catheter for arthroscopic and reconstructive shoulder surgery. J Shoulder Elbow Surg. 2022 Jun;31(6S):S152-S157. doi: 10.1016/j.jse.2022.02.004. Epub 2022 Mar 15.

  PMID: 35301140 BACKGROUND

• Levin JM, Charalambous LT, Girden A, Twomey-Kozak J, Goltz D, Wickman J, Bullock WM, Gadsden JC, Klifto CS, Anakwenze OA. Interscalene block with liposomal bupivacaine versus continuous interscalene catheter in primary total shoulder arthroplasty. J Shoulder Elbow Surg. 2022 Oct;31(10):e473-e479. doi: 10.1016/j.jse.2022.03.013. Epub 2022 Apr 25.

  PMID: 35472576 BACKGROUND

• Schoenherr JW, Gonzalez M, Serrano R, Park M, Lee Z, Cobb K, Howard C, Flynn D, Li Q, Grant S, Bullard T. Quality of Recovery After Rotator Cuff Repair With Interscalene Liposomal Bupivacaine Versus Interscalene Nerve Catheter. Orthop J Sports Med. 2022 Nov 22;10(11):23259671221134819. doi: 10.1177/23259671221134819. eCollection 2022 Nov.

  PMID: 36458106 BACKGROUND

• Ilfeld BM, Viscusi ER, Hadzic A, Minkowitz HS, Morren MD, Lookabaugh J, Joshi GP. Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):572-82. doi: 10.1097/AAP.0000000000000283.

  PMID: 26204387 BACKGROUND

• Malik O, Kaye AD, Kaye A, Belani K, Urman RD. Emerging roles of liposomal bupivacaine in anesthesia practice. J Anaesthesiol Clin Pharmacol. 2017 Apr-Jun;33(2):151-156. doi: 10.4103/joacp.JOACP_375_15.

  PMID: 28781438 BACKGROUND

• Joshi GP, Patou G, Kharitonov V. The safety of liposome bupivacaine following various routes of administration in animals. J Pain Res. 2015 Oct 30;8:781-9. doi: 10.2147/JPR.S85424. eCollection 2015.

  PMID: 26586964 BACKGROUND

• Sercombe L, Veerati T, Moheimani F, Wu SY, Sood AK, Hua S. Advances and Challenges of Liposome Assisted Drug Delivery. Front Pharmacol. 2015 Dec 1;6:286. doi: 10.3389/fphar.2015.00286. eCollection 2015.

  PMID: 26648870 BACKGROUND

• Campos JH, Seering M, Peacher D. Is the Role of Liposomal Bupivacaine the Future of Analgesia for Thoracic Surgery? An Update and Review. J Cardiothorac Vasc Anesth. 2020 Nov;34(11):3093-3103. doi: 10.1053/j.jvca.2019.11.014. Epub 2019 Nov 18. No abstract available.

  PMID: 31899142 BACKGROUND

• Matar RN, Shah NS, Grawe BM. Patient-Reported Outcomes Measurement Information System Scores Are Inconsistently Correlated With Legacy Patient-Reported Outcome Measures in Shoulder Pathology: A Systematic Review. Arthroscopy. 2021 Apr;37(4):1301-1309.e1. doi: 10.1016/j.arthro.2020.11.039. Epub 2020 Nov 27.

  PMID: 33253797 BACKGROUND

• Guo EW, Elhage K, Cross AG, Hessburg L, Gulledge CM, Mehta N, Verma NN, Makhni EC. Establishing and comparing reference preoperative Patient-Reported Outcomes Measurement Information System (PROMIS) scores in patients undergoing shoulder surgery. J Shoulder Elbow Surg. 2021 Jun;30(6):1223-1229. doi: 10.1016/j.jse.2020.09.003. Epub 2020 Oct 1.

  PMID: 33010435 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Melinda Seering, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melinda Seering, MD

CONTACT

5156895508; melinda-seering@uiowa.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Prospective Randomized Control

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 22, 2023
• Study Start: August 19, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: IPD will be available for sharing immediately after publication and ending 5 years following article publication
• Access Criteria: IPD will be accessible to researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal

Locations

US (1)