Trial of Extended Release Bupivacaine for Pain Relief After Surgery

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.