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

Total Shoulder Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06143306
• Other study ID #: ANES-2023-32053
• Status: Recruiting
• Phase: Phase 4
• Start date: March 20, 2024
• Est. completion date: May 1, 2027

Study information

• Verified date: March 2024
• Source: University of Minnesota
• Contact: Candace Nelson
• Phone: 612-625-7116
• Email: nelso377[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: May 1, 2027
• Est. primary completion date: October 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Total Shoulder Arthroplasty

Intervention

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

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum pain	This measurement is the highest pain score within the first 24 hours post-op. Please change abbreviations for time frames to minutes, hours and years respectively. And the Scale is 0 being no pain to 10 being worst pain.	24 hours postop
Secondary	Opioid use	Opioid use reported as MME	24 hours postop, 48 hours postop
Secondary	Functional pain score	The scale used in a modified QOR (quality of Recovery) scale. It's 15 questions based off the adult QOR scale which assesses impact of pain on the patient's daily activities	24 hours postop, 48hours postop
Secondary	hospital length of stay	This is a standard post-operative outcome that relates to the surgical recovery period. Idon't know what options you have to select for time frame, but please either select post-op or explain this standard.	5 days