Recruiting

Interscalene Catheter vs. Block

Sponsor:

Melinda Seering

Code:

NCT05868330

Conditions

Post Operative Pain

Anesthesia

Nerve Block

Shoulder Osteoarthritis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Interscalene Catheter

Exparel Single Shot Interscalene Block

Study Details

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

Study ID

NCT05868330

Start date

Aug 19, 2024

Status verified date

Nov, 2025

Completion date

Jan, 2027

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

56 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Interscalene Catheter

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

active comparator: Exparel Single Shot Interscalene Block

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

Interventions

Interscalene 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

Exparel 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.

Primary outcome measure

  • Pain Score Assessed by functional pain score at POD 1 [ Time Frame: The primary outcome will occur at 1 day after surgery date ]

Central Contacts and Locations

Central contacts

Locations

University of Iowa Hospital and Clinics

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

More Information

Sponsor

Melinda Seering

Last update posted

Nov 10, 2025

Last verified

Nov, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Melinda Seering on 2025-11-10.