Clinical trial: NCT03304444
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks

The most common adverse reactions include itching, constipation, nausea and vomiting (incidence greater than or equal to 10%). Other common adverse reactions include pyrexia, dizziness, anemia, hypothension, prurities (incidence between 2% and 10%). The rare adverse reactions (incidence less than 2%) include, but are not limited to, chills, erythema, bradycardia, pain, edema, syncope. You also may experience typical postoperative pain that may require additional pain medications.  
Your participation may be terminated by the investigators if there is clear advantage to using the experimental liposomal bupivacaine over conventional bupivacaine HCl during the duration of the study. Other circumstances under which your participation may be terminated include adverse effect from the local anesthetic you receive. There will be no consequences if you decide to withdraw from the study. Significant new findings that develop during the course of the research, which may affect your willingness to participate, will be provided to you. Potential health benefits to the subject may include decreased postoperative pain, reduced necessity for narcotic use, and decreased length of stay in the hospital.  
There will be no materials such as tissue or blood sent or stored for this study.  
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Clinical trial: NCT03304444
Section: Purpose of Research
Subsections: Purpose Of This Research Study

Your participation in the study includes consent for the administration of a transversus abdominis plane block ("TAP block"). This procedure is intended to augment the effects of other medications to significantly reduce the intensity of postoperative pain you will experience. An anesthesiologist who is participating in this study will describe the TAP block to you during your preoperative interview, and he or she will obtain your consent for the procedure along with your consent for the anesthesia you will receive for your intended surgery. As part of the study, you will be asked to answer various questions after your surgery regarding your experience of postoperative pain. The total number of research subjects in this study is expected to be approximately 128. The use of TAP blocks has become regarded as a significant advance in the control of postoperative pain following abdominal surgery. Traditionally TAP blocks are done with use of bupivacaine HCl. Recently a new version of this medication has been approved for injection into surgical site for longer duration pain relief. The purpose of the current study is to evaluate the use of a conventional local anesthetic agent (bupivacaine HCl) compared to the use of a novel form of the same agent (liposomal bupivacaine) which is reputed to have a longer duration of action. Given that this comparison has never been studied before, this study will be a pilot study. The study will help determine whether liposomal bupivacaine has specific advantages over conventional bupivacaine HCl when given in a TAP block for lower abdominal surgery.  
The study will measure outcomes such as length of stay in hospital, use of post operative opioids, and monitor for any adverse effects of both bupivacaine HCl and liposomal bupivacaine.  
The FDA has approved the use and infiltration of liposomal bupivacaine into the TAP for use of TAP
block, and falls within the scope of liposomal bupivicaine's current indications.  
All patients undergoing open abdominal surgery performed by Dr, Shahin, Dr. Burton, Dr. Edelson, Dr.  
Sorosky, or Dr. Kohl will be consented for TAP block by an anesthesiologist. You will be randomly assigned to receive either bupivicaine or the test material (liposomal bupivicaine) through a computer process which is blinded to the surgeon. All TAP blocks will be placed after the abdominal incision is closed but before you are allowed to awaken. Your anesthesiologist will place this TAP block under ultrasound guidance. The anesthesiologist will identify the correct site of infiltration using an ultrasound and test this area with normal saline first. They will then infiltrate the site with either the control (bupivacaine HCl) or the test material (liposomal bupivacaine). You will also receive a narcotic through your IV post operatively before you wake from anesthesia and prior to extubation, no matter which arm of the study you belong to.