Addition of a Pectoserratus Block to Interscalene Block in Patients Undergoing Total Shoulder Replacement

The use of ISB in patients undergoing total shoulder arthroplasty (TSA) is the gold standard and results in significantly reduced pain scores and opioid use. However, patients still have pain and the majority require opioids postoperatively as the interscalene block (ISB) doesn't cover all of the dermatomes impacted during TSA. A pectoserratus block typically provides coverage to additional dermatomes that are impacted during TSA. Currently ISB is performed for every patient and perform a pectoserratus block to a portion of our patients undergoing TSA. The purpose of the study is to determine if the addition of the pectoserratus block to the ISB will results in improvement in pain control and decrease in opioid use, among patients undergoing TSA. This is a randomized prospective controlled trial. All patients undergoing total shoulder arthroplasty or reverse total shoulder arthroplasty aged 18-85 will be considered eligible for the study. Participants will be randomized to one of 2 treatment groups. Group 1 will receive an ultrasound guided pectoserratus block with 25 mL of 0.25% bupivacaine. Group 2 will be the control and receive an ultrasound guided pectoserratus block with 25 mL of saline. The drug will be administered by the anesthesiologist in-charge of the participant's care or an anesthesiologist who is a part of the study team.

Study Overview

• Status: Recruiting
• Conditions: Total Shoulder Arthroplasty
• Intervention / Treatment: Drug: bupivacaine.; Drug: Saline

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Candace Nelson; Phone Number: 612-625-7116; Email: nelso377@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota
      • Contact: Candace Nelson; Email: nelso377@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients undergoing total shoulder arthroplasty or reverse total shoulder arthroplasty;
• Patients aged 18-85 years old.

Exclusion Criteria:

• Patients who have an exclusion to regional anesthesia such as pre-existing nerve damage to their brachial plexus or infection at the site of injection.
• Patients who have exclusion to interscalene blockade such as severe lung disease.
• Non-English speakers will be excluded because pain scales are not validated in other languages and there is lack of standardization of pain reporting.
• Pregnant patients
• Patients who are currently using opioids and patients with a diagnosis of chronic pain will be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bupivacaine group; Patients undergoing total shoulder arthroplasty or reverse total shoulderarthroplasty aged 18- 85, randomized to the experimental group.	Drug: bupivacaine.; an ultrasound guided pectoserratus block with 25 mL of 0.25% bupivacaine
Placebo Comparator: control group; Patients undergoing total shoulder arthroplasty or reverse total shoulderarthroplasty aged 18- 85, randomized to the control group.	Drug: Saline; an ultrasound guided pectoserratus block with 25 mL of saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum pain	This measurement is the highest pain score within the first 24 hours post-op. Please change abbreviations for time frames to minutes, hours and years respectively. And the Scale is 0 being no pain to 10 being worst pain.	24 hours postop

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid use	Opioid use reported as MME	24 hours postop, 48 hours postop
Functional pain score	The scale used in a modified QOR (quality of Recovery) scale. It's 15 questions based off the adult QOR scale which assesses impact of pain on the patient's daily activities	24 hours postop, 48hours postop
hospital length of stay	This is a standard post-operative outcome that relates to the surgical recovery period. Idon't know what options you have to select for time frame, but please either select post-op or explain this standard.	5 days

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Jacob Hutchins, MD, MHA, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2024
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Actual): November 22, 2023

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Bupivacaine; Sodium Chloride
• Other Study ID Numbers: ANES-2023-32053

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No