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

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Start date: Mar 20, 2024 to Aug 14, 2024v6
  2. Minor Re-verified, no change to tracked fieldsv5
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 1, 2024 to Mar 20, 2024
    • Site details revised
    v4
  4. Notable Start date: Feb 1, 2024 to Apr 1, 2024
    • Primary completion date: Aug 30, 2026 to Oct 30, 2026
    • Study completion date: Mar 1, 2027 to May 1, 2027
    v3
  5. Notable Start date: Nov 30, 2023 to Feb 1, 2024
    • Primary completion date: May 30, 2026 to Aug 30, 2026
    • Study completion date: Nov 30, 2026 to Mar 1, 2027
    v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06143306
Lead Sponsor University of Minnesota
Conditions
(from sponsor)
Total Shoulder Arthroplasty
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov