Postoperative Pain, Shoulder Arthroscopic Surgeries
Conditions
Brief summary
This prospective randomized clinical trial evaluates the duration of sensory blockade in patients undergoing shoulder surgery receiving interscalene brachial plexus blocks with either liposomal bupivacaine alone or liposomal bupivacaine combined with dexamethasone.
Interventions
Administration of an interscalene brachial plexus nerve block using 10 mL liposomal bupivacaine (133 mg) and 20 mL of 0.5% bupivacaine for postoperative analgesia following shoulder surgery.
DRUGDexamethasone
6 mg preservative-free dexamethasone
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
Provider given care is not preparing study drug
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Adults aged 18 to 80 years 2. ASA physical status 1-3 3. Undergoing primary shoulder surgery with interscalene nerve block
Exclusion criteria
1. ASA 4 or 5 2. Revision shoulder surgery 3. Daily chronic opioid use (over 3 months of continuous opioid use) 4. Inability to communicate pain scores or need for analgesia 5. Infection at the site of block placement 6. Age under 18 years old or greater than 80 years old 7. Pregnant women (as determined by point-of-care serum bHCG) 8. Intolerance/allergy to local anesthetics 9. Weight \<50 kg 10. BMI \> 40 11. severe pulmonary disease including chronic obstructive pulmonary disease and restrictive lung disease 12. Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years. 13. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance. 14. Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time until resolution of sensory block | 0-10 days | Patients will be called daily until resolution of their sensory block |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| duration of motor blockade | 2, 12, 24, 36, 48, 72, and 96 hours postoperatively | — |
| pain scores (scale of 0-10) | 2, 12, 24, 36, 48, 72, and 96 hours postoperatively | Numeric Pain Rating Scale (NPRS): A score of 0 means "no pain," and 10 means "the worst pain imaginable |
| opioid consumption (in oral morphine equivalents) | 2, 12, 24, 36, 48, 72, and 96 hours postoperatively | — |
| known side effects of interscalene blocks | 2, 12, 24, 36, 48, 72, and 96 hours postoperatively | — |
Contacts
PRINCIPAL_INVESTIGATOREmily Hall
Duke University
Outcome results
None listed