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NCT06143306 · ClinicalTrials.gov registry record · Phase 4
Addition of a Pectoserratus Block to Interscalene Block in Patients Undergoing Total Shoulder Replacement
A Phase 4 study of Total Shoulder Arthroplasty, sponsored by University of Minnesota.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 110
- Enrollment target
- 1
- Study location
NCT06143306 is a Phase 4 study of Total Shoulder Arthroplasty that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 110 participants, above the 58-participant average among 3 other Total Shoulder Arthroplasty trials with a reported enrollment target (90% higher). The trial reports 1 study location across 1 state.
The verdict
NCT06143306, a Phase 4 study of Total Shoulder Arthroplasty, is actively recruiting participants, sponsored by University of Minnesota.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 110 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DRUG Saline
- DRUG bupivacaine.
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2024-08-14 |
| Est. Completion | 2027-05-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06143306
The ClinicalTrials.gov registry entry for NCT06143306 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 58-participant average among 3 other Total Shoulder Arthroplasty trials with a reported enrollment target (90% higher). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Total Shoulder Arthroplasty appearing as the primary indexed condition, and to 2 interventions - of which Saline is the first listed.
NCT06143306 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT06143306 about?
NCT06143306 is a clinical study titled "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 de...
What is the current status of trial NCT06143306?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 110 participants. The study started on 2024-08-14. Estimated completion is 2027-05-01.
What conditions does trial NCT06143306 study?
This clinical trial studies the following conditions: Total Shoulder Arthroplasty.
What interventions are being tested in trial NCT06143306?
The interventions under investigation include: Saline (DRUG), bupivacaine. (DRUG).
Who is sponsoring clinical trial NCT06143306?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06143306 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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