Addition of a Pectoserratus Block to Interscalene Block in Patients Undergoing Total Shoulder Replacement
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: bupivacaine., Saline.
- Who it may be relevant to
- Registry conditions: Total Shoulder Arthroplasty. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug bupivacaine.
an ultrasound guided pectoserratus block with 25 mL of 0.25% bupivacaine - Drug Saline
an ultrasound guided pectoserratus block with 25 mL of saline
Primary outcome measures
- Maximum pain [Time frame: 24 hours postop]
Secondary outcome measures (3)
- Opioid use [Time frame: 24 hours postop, 48 hours postop]
- Functional pain score [Time frame: 24 hours postop, 48hours postop]
- hospital length of stay [Time frame: 5 days]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of Minnesota — Minneapolis
Identifiers
NCT: NCT06143306 · ANES-2023-32053