Trial of Extended Release Bupivacaine for Pain Relief After Surgery (PERSIST)

This is an interventional treatment trial for Post Operative Pain focused on measuring Post-operative pain, non-opioid analgesic, opioid reduction, laparoscopic cholecystectomy, laparoscopic surgery, bupivacaine, extended release, locally acting analgesic Read More

Inclusion Criteria:

• Patients scheduled for elective outpatient laparoscopic cholecystectomy using a conventional 4-port laparoscopic procedure.
• Must be able and willing to provide written informed consent, complete trial-related procedures, and communicate with the trial staff.
• Males and females 18 years of age or older.
• ASA Class I, II, or III.
• Patients of child-bearing potential must agree to use a medically acceptable method of contraception to prevent pregnancy for the duration of their participation in the trial.
• Must be living close enough to the investigative site to attend the four scheduled follow-up clinic visits.

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.