Trial of Extended Release Bupivacaine for Pain Relief After Surgery

Inclusion Criteria:

- Patients scheduled for elective outpatient laparoscopic cholecystectomy using a
conventional 4-port laparoscopic procedure.

- Must be able and willing to provide written informed consent, complete trial-related
procedures, and communicate with the trial staff.

- Males and females 18 years of age or older.

- ASA Class I, II, or III.

- Patients of child-bearing potential must agree to use a medically acceptable method of
contraception to prevent pregnancy for the duration of their participation in the
trial.

- Must be living close enough to the investigative site to attend the four scheduled
follow-up clinic visits.

Exclusion Criteria:

- Pregnant or nursing females.

- Patients with absolute or relative contraindications to laparoscopic cholecystectomy.

- Patients with prior midline abdominal surgery who are at risk for adhesions that may
complicate laparoscopic cholecystectomy and/or accurate pain assessments.

- Patients requiring emergency surgery or urgent surgery (fewer than 5 days between
screening and surgery).

- Patients with a pre-planned overnight stay or pre-planned hospital admission.

- Patients scheduled for single incision, mini trocars, natural orifice transluminal
endoscopic surgery (NOTES), robotic laparoscopic procedures, or any procedure (other
than cholangiograms and minimal adhesiolysis) in addition to laparoscopic
cholecystectomy.

- Patients with known hypersensitivity to amide local anesthetics such as bupivacaine.

- Patients with acute pain that is not due to cholecystitis.

- Patients with a history of chronic pain unrelated to gallbladder disease.

- Patients with ongoing depression or psychosis.

- Patients undergoing long-term treatment with opioids or other analgesics, including
acetaminophen, NSAIDs, anticonvulsants (gabapentin or pregabalin), and antidepressants
(SSRIs, SNRIs, and tricyclics), but not including daily low-dose aspirin.

- Patients who are being treated chronically with systemic corticosteroids or who will
require peri-operative corticosteroids because of adrenal insufficiency (inhalational
or topical corticosteroids are permitted).

- Patients who may be unsuitable for opioid administration (such as sensitivity [e.g.,
history of severe nausea and vomiting] hypersensitivity, known history of abuse or
addiction, or unwillingness to take prescribed rescue opioids).

- Use of anticoagulants and antiplatelet drugs (with exception of low dose aspirin) in
the 1 week prior to surgery.

- Patients who are incapable of operating the electronic diary.

- Patients participating in any other trial with an investigational drug or device
concurrently or less than 30 days prior to surgery for this trial.

- Patients who, in the Investigator's opinion, should not participate in the trial or
may not be capable of following the trial procedures for any reason.