Clinical trial NCT06143306: Addition of a Pectoserratus Block to Interscalene Block in Patients Undergoing Total Shoulder Replacement
Official title: Addition of a Pectoserratus Block to Interscalene Block in Patients Undergoing Total Shoulder Replacement
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Total Shoulder Arthroplasty
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2023-11-22
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Primary outcomes:
measure: Maximum pain
timeFrame: 24 hours postop
Secondary outcomes:
measure: Opioid use
timeFrame: 24 hours postop, 48 hours postop
measure: Functional pain score
timeFrame: 24 hours postop, 48hours postop
measure: hospital length of stay
timeFrame: 5 days
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Jacob Hutchins, MD, MHA
role: PRINCIPAL_INVESTIGATOR
References: