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

NCT06143306 | Recruiting Phase 4 FDA Drug

• 1 other identifier: ANES-2023-32053
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Total Shoulder Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Opioid use

  24 hours postop, 48 hours postop

• Functional pain score

  24 hours postop, 48hours postop

• hospital length of stay

  5 days

Study Arms (2)

Bupivacaine group

EXPERIMENTAL

Patients undergoing total shoulder arthroplasty or reverse total shoulderarthroplasty aged 18- 85, randomized to the experimental group.

Drug: bupivacaine.

control group

PLACEBO COMPARATOR

Patients undergoing total shoulder arthroplasty or reverse total shoulderarthroplasty aged 18- 85, randomized to the control group.

Drug: Saline

Interventions

bupivacaine. DRUG

an ultrasound guided pectoserratus block with 25 mL of 0.25% bupivacaine

Bupivacaine group

Saline DRUG

an ultrasound guided pectoserratus block with 25 mL of saline

control group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Interventions

Bupivacaine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Jacob Hutchins, MD, MHA

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Candace Nelson

CONTACT

612-625-7116; nelso377@umn.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This will be double blinded. The surgeon performing the surgery and the research team member collecting follow-up pain and opioid data will be blinded to the randomization assigned to the patient. The anesthesiologist performing the block and the medical assistant preparing the drugs for the anesthesiologist will be unblinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: November 22, 2023
• Study Start: August 14, 2024
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

US (1)