A Health Economic Trial in Adult Patients Undergoing Laparoscopic Colectomy (IMPROVE-Lap Colectomy) MA402S23B606

This is a phase 3b, prospective, sequential, open-label study designed to evaluate the
efficacy, safety, and health economic benefits of intraoperative local wound infiltration
with SKY0402 (bupivacaine liposome extended-release injectable suspension), compared with
postsurgical administration of standardized intravenous (IV) morphine sulfate, for
postsurgical analgesia in adult patients undergoing laparoscopic colectomy with general
anesthesia.

Inclusion Criteria:

- Male or female, >/= 18 years of age

- Patients scheduled to undergo laparoscopic-assisted colectomy with planned primary
anastamosis, as defined by cecectomy, right hemicolectomy, resection of transverse
colon, left hemicolectomy, or sigmoidectomy. (Note: patients who convert from a
planned laparoscopic colectomy to an open colectomy are not eligible)

- Ability to provide informed consent, adhere to study visit schedule, and complete all
assessments.

Exclusion Criteria:

- Patients with a history of hypersensitivity or idiosyncratic reactions or intolerance
to any local anesthetic, opioid, or propofol.

- Patients who abuse alcohol or other drug substance.

- Patients with severe hepatic impairment.

- Patients currently pregnant or who may become pregnant during the course of the
study.

- Patients with any psychiatric, psychological, or other condition that the
Investigator feels may make the patient an inappropriate candidate for this clinical
study.

- Patients who have participated in a SKY0402 study within the last 30 days.

- Patients who have received an investigational drug within 30 days prior to study drug
administration, or planned administration of another investigational product or
procedure during the patient's participation in this study.

In addition, the patient will be ineligible if he/she meets the following criteria during
surgery:

- Patients with unplanned multiple segmental resections or large intestine.

- Patients who convert from laparoscopic-assisted colectomy to traditional open
colectomy.

- Patients who have unplanned, temporary, or permanent colostomies placed.

- Patients who receive intraoperative administration of opioids (other than fentanyl or
analogs) or any other analgesic, local anesthetics, or anti-inflammatory agents.

- Patients who receive Entereg(R).