Wound Infiltration With Liposomal Bupivacaine vs. Standard Wound Infiltration With Bupivacaine in Patient's Undergoing Open Gynecologic Surgery on an Enhanced Recovery Pathway

• Status: Terminated
• Trial end date: 2020-07-23
• Target enrollment: 0
• Participant gender: Female

Summary

Bupivacaine is a drug that is traditionally given as an injection to numb surgical sites. Liposomes are molecules that are similar to fats. Sometimes drugs are combined with liposomes to make them able to stay in the body for longer periods of time. This has been done with bupivacaine to create liposomal bupivacaine.

The goal of this clinical research study is to compare the effects of bupivacaine to those of liposomal bupivacaine when given to patients who are having gynecologic surgery. Researchers want to compare how long the drugs work to numb the wound and how long patients take to recover from surgery.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Pacira Pharmaceuticals, Inc
• Treatments: Bupivacaine; Oxycodone

Criteria

Inclusion Criteria:

1. Undergoing an exploratory laparotomy for suspected gynecologic cancer, which includes metastatic disease from neoplasia originating in other organs

2. Planned participation in the Gynecologic Enhanced Recovery Pathway

3. Female 18 years of age or older

4. Patient must be able to read and speak English

5. Consents to being part of a randomized, single-blinded study

6. Patient has physical and mental capabilities to take part in study

7. Bilirubin less than or equal to 1.5 x upper limit of the normal range (ULN); Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic-Pyruvic Transaminase (SGPT)

8. If the patient is of childbearing potential, the patient must have a negative blood or urine pregnancy test within 14 days of surgical treatment on study

Exclusion Criteria:

1. Sensitivity to amide-type local anesthetics

2. Patients on long-acting opioid medications, or scheduled (four or more times a day for seven or more days) short-acting opioid medications within the last 30 days

3. Emergency surgery of any type that does not allow for proper time for protocol review by the patient

4. Surgery that involves known/anticipated resection of anterior abdominal wall with plastic surgery reconstruction

5. Patients undergoing pelvic exenteration

6. Patients undergoing known/anticipated anterior abdominal wall hernia repairs

7. Patients weighing <50 kg