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

Study Overview
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Brief Summary
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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.

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

Conditions
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Total Shoulder Arthroplasty

Intervention / Treatment
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* Drug: bupivacaine.
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bupivacaine group<br>Patients undergoing total shoulder arthroplasty or reverse total shoulderarthroplasty aged 18- 85, randomized to the experimental group. | Drug: bupivacaine.<br>* an ultrasound guided pectoserratus block with 25 mL of 0.25% bupivacaine<br>|
| Placebo Comparator: control group<br>Patients undergoing total shoulder arthroplasty or reverse total shoulderarthroplasty aged 18- 85, randomized to the control group. | Drug: Saline<br>* an ultrasound guided pectoserratus block with 25 mL of saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid use | Opioid use reported as MME | 24 hours postop, 48 hours postop | 
| 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 | 
| 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 |