NCT06143306 Addition of a Pectoserratus Block to Interscalene Block in Patients Undergoing Total Shoulder Replacement
| NCT ID | NCT06143306 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Minnesota |
| Condition | Total Shoulder Arthroplasty |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2024-08-14 |
| Primary Completion | 2026-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 110 participants in total. It began in 2024-08-14 with a primary completion date of 2026-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Jacob Hutchins, MD, MHA
PRINCIPAL INVESTIGATOR
University of Minnesota
Frequently Asked Questions
Who can join the NCT06143306 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Total Shoulder Arthroplasty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06143306 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06143306 currently recruiting?
Yes, NCT06143306 is actively recruiting participants. Contact the research team at nelso377@umn.edu for enrollment information.
Where is the NCT06143306 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT06143306 clinical trial?
NCT06143306 is sponsored by University of Minnesota. The principal investigator is Jacob Hutchins, MD, MHA at University of Minnesota. The trial plans to enroll 110 participants.