PAIN - Postoperative Analgesia INvestigation (PAIN)
Postoperative Pain
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring Postoperative pain, sternotomy, laparotomy, thoracotomy, mini-thoracotomy, truncal surgical incisions, local anaesthetics, bupivacaine
Eligibility Criteria
Inclusion Criteria:
- 18 years-old or older, and
- Sternotomy, thoracotomy, laparotomy or mini-thoracotomy incision is planned
- There is reasonable expectation that the patient will be extubated within 24 hours after surgery
Exclusion Criteria:
- The patient has a known allergy to morphine or any opioid
- The patient has a known chronic pain disorder or takes daily opioid medication > 1 month prior to surgery
- There is anticipated difficulty communicating pain status due to language or other barriers at the investigator discretion
- High postoperative morbidity index based on preoperative assessment, such as, low likelihood of extubation within 24 hours, extensive thoracoabdominal aortic aneurysm (Extent 2 TAAA), preoperative renal insufficiency/failure, etc.
Sites / Locations
- Department of Cardiothoracic and Vascular Surgery and Memorial Hermann Heart and Vascular Institute - Texas Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Exparel®
Regular Bupivacaine
Patients in this group will receive will receive the study drug [bupivacaine liposomal injectable suspension (Exparel®)] and Patient Controlled Analgesia (PCA). Exparel® is an FDA-approved bupivacaine liposome injectable suspension produced by Pacira Pharmaceuticals.
Patients in this group will receive will receive the standard regular bupivacaine hydrochloride (HCl) and PCA. Bupivacaine HCl is an FDA-approved injectable suspension. The standard non-liposomal bupivacaine will be from Hospira pharmaceuticals