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

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT06143306
Phase
PHASE4
Status
Recruiting
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Conditions

  • Total Shoulder Arthroplasty

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • bupivacaine. — DRUG
    an ultrasound guided pectoserratus block with 25 mL of 0.25% bupivacaine
  • Saline — DRUG
    an ultrasound guided pectoserratus block with 25 mL of saline

Study Details

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.

Key Dates

Start date
Aug 14, 2024
Status verified
Mar 2026
Primary completion
Oct 30, 2026
Completion
May 1, 2027

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Bupivacaine group
    Patients undergoing total shoulder arthroplasty or reverse total shoulderarthroplasty aged 18- 85, randomized to the experimental group.
  • Placebo Comparator: control group
    Patients undergoing total shoulder arthroplasty or reverse total shoulderarthroplasty aged 18- 85, randomized to the control group.

Primary Outcome Measure

Maximum pain [ Time Frame: 24 hours postop ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55455
Candace Nelson
[email protected]

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By research site
University of Minnesota· Minneapolis, MN

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