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Procedure

Pectoserratus Block + Interscalene Block for Shoulder Surgery

Phase 4

Recruiting

Led By Jacob Hutchins, MD, MHA

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients aged 18-85 years old

Patients undergoing total shoulder arthroplasty or reverse total shoulder arthroplasty

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours postop, 48hours postop

Awards & highlights

Study Summary

This trial studies if adding a nerve block to a common shoulder surgery reduces pain and opioid use. All patients 18-85 years old undergoing shoulder surgery are eligible.

Who is the study for?

This trial is for patients aged 18-85 undergoing total shoulder replacement surgery. It's suitable for those who can receive an ultrasound-guided block as part of their pain management.Check my eligibility

What is being tested?

The study tests if adding a pectoserratus block with bupivacaine to the standard interscalene block improves pain control and reduces opioid use after shoulder replacement surgery, compared to using saline.See study design

What are the potential side effects?

Bupivacaine may cause side effects like numbness and weakness in the area it's injected, low blood pressure, nausea, or headaches. Saline is generally safe but might cause mild discomfort at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 85 years old.

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I am having a total or reverse shoulder replacement surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours postop, 48hours postop

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours postop, 48hours postop

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours postop, 48hours postop for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum pain

Secondary outcome measures

Functional pain score

Opioid use

hospital length of stay

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Bupivacaine groupExperimental Treatment1 Intervention

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

Group II: control groupPlacebo Group1 Intervention

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor

1,381 Previous Clinical Trials

1,588,865 Total Patients Enrolled

Jacob Hutchins, MD, MHAPrincipal InvestigatorUniversity of Minnesota

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Food and Drug Administration sanctioned Bupivacaine group for therapeutic applications?

"There is sufficient evidence from prior clinical trials to suggest that Bupivacaine group has a high safety rating of 3 on the scale. This treatment is approved and ready for use in this Phase 4 trial."

Answered by AI

Are there any remaining vacancies in this experiment?

"Clinicaltrials.gov shows that this trial, which initially opened enrollment on November 30th 2023 and was last updated a fortnight later, is no longer recruiting patients. However, 3 other trials are still actively searching for volunteers at the present moment in time."

Answered by AI

Are individuals over the age of 45 eligible to participate in this investigation?

"According to the parameters of this clinical trial, prospective participants need to be aged 18 or above and no older than 85."

Answered by AI

Does my profile meet the criteria for this experiment?

"Potential participants of this clinical trial must have had a total shoulder replacement and be between 18 to 85 years old. The research team is seeking 110 enrollees for the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Addition of a Pectoserratus Block to Interscalene Block in Patients Undergoing Total Shoulder Replacement". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06143306.

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