Overview

Improving Pain Management After Total Shoulder Replacement Using Bupivacaine Liposome

Status:
Recruiting

Trial end date:
2022-05-01

Target enrollment:
0

Participant gender:
All

Summary

To improve pain control and decrease opioid requirements for subjects undergoing Total Shoulder Replacement.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Massachusetts, Worcester

Treatments:

Acetaminophen
Bupivacaine
Epinephrine
Epinephryl borate
Gabapentin
Oxycodone
Racepinephrine

Criteria

Inclusion Criteria:

1. Adult subjects older than 18years old undergoing Total Shoulder Replacement (TSR) or
reverse TSR surgery.

2. Meet criteria for regional nerve block.

3. Weight greater than 60kg (safety to keep liposomal bupivacaine and bupivacaine dosing
below 3mg/kg).

Exclusion Criteria:

1. Recent drug use

2. Subjects on chronic buprenorphine therapy (either for opioid replacement or pain
control).

3. Nerve injury (cervical stenosis, trauma, etc) of the surgical limb.

4. Coagulopathy

5. Subjects with significant liver disease (as amide type local anesthetics such as
bupivacaine are metabolized by the liver).

6. Infection near or in the area of the nerve block.

7. Subject refusal of regional anesthesia.

8. Vulnerable populations (prisoners, mental impairment / dementia, etc).

9. Subjects requiring interpreter services (not proficient in English).

10. Subjects with poor cardio-pulmonary reserve who might not tolerate a
hemi-diaphragmatic paralysis or hemi-diaphragmatic paresis.