Liposomal Bupivacaine in Total Shoulder Arthroplasty

Study Design: A randomized single blinded standard of care controlled clinical trial
comparing pain management interventions. All patients over age eighteen and scheduled for
primary shoulder arthroplasty (SA) a three fellowship trained surgeons will be eligible for
inclusion. Patients will be excluded if their medical history presents known allergies or
intolerance to dexamethasone, opioid or bupivacaine, substantial alcohol or drug abuse, and
pregnancy.

Liposomal Bupivacaine has a refrigerated shelf life of one month the investigational
facility. Patients will be sequentially recruited into the randomization process. Liposomal
Bupivacaine will be held by the Henry Ford hospital pharmacy up to one month prior to
planned shoulder arthroplasty in anticipation of surgery on eligible patients. The sterile
solutions will be delivered to and kept by the inpatient clinical pharmacy until the date of
surgery and delivered to the operating room at the beginning of a surgical case. The current
dose of Liposomal Bupivacaine has been chosen based on previously published data of local
infiltrative analgesia with Liposomal Bupivacaine and one published study on Liposomal
Bupivacaine efficacy.

The week prior to surgery, patients will be randomized to receive Local infiltration
anesthesia (LIA) with Liposomal Bupivacaine, or Inter-scalene nerve block (INB) using a
computer generated sequence. The results of randomization will be securely delivered to the
anesthesiologist and the surgeon the week prior. The anesthesiologist will view the assigned
group to determine if a preoperative INB will be given. Depending on the randomization group
either an Liposomal Bupivacaine solution will be delivered to the operating room for local
infiltration or the anesthesiologist will perform a preoperative INB.

Patients in the Liposomal Bupivacaine group will receive LIA with 10cc(133mg) of Liposomal
Bupivacaine solution dissolved in 20cc of sterile saline before wound closure. The solution
will be applied to the wound bed, muscles, and periosteum. The solution will be left
unperturbed for five minutes. Thereafter the solution will be suctioned from the wound and
the shoulder joint. Incisions will be closed in typical fashion and the wound dressed.The
tourniquet will be deflated.

Patients in the INB will receive postoperative ultrasound guided INB. Experienced
anesthesiologists will apply all INBs in this study.

Following the procedure pain will be accessed subjectively through visual analog scale and
numeric rating scale pain scores, pain diaries given to the patient to record at home, pain
summary scores at follow up visits and objectively through narcotic pain requirement. A
blind observer will also access outcomes.

Planned Data Analysis:

Means and standard deviations, as well as medians and interquartile ranges will be computed
for pain scores.These outcomes will be compared by Wilcoxon rank sum tests. The amount of
pain medication and pain scores will be compared by Wilcoxon rank sum tests.

Inclusion Criteria:

- Patients over the age of 18 scheduled for primary shoulder arthroplasty by three
fellowship trained surgeons will be eligible for inclusion

Exclusion Criteria:

- Patients will be excluded if their medical history presents known allergies or
intolerance to dexamethasone, opioid or bupivacaine, substantial alcohol or drug
abuse, and pregnancy.