Trial of Extended Release Bupivacaine for Pain Relief After Surgery
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Intervention: SABER-Bupivacaine (Part 1); SABER-Bupivacaine (Part 2); Saline Placebo; Bupivacaine HCl
Intervention description: 5 ml once at end of surgery; 5 ml once at end of surgery; 5 ml once at end of surgery; 0.5%, 15 ml, once at end of surgery
Intervention MeSH terms: Bupivacaine; Pharmaceutical Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 399.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Post-operative pain; non-opioid analgesic; opioid reduction; laparoscopic cholecystectomy; laparoscopic surgery; bupivacaine; extended release; locally acting analgesic

Summary:

      This is a research study of SABER® -Bupivacaine, an experimental medication designed to
      reduce pain for up to 3 days after surgery. Given once by the surgeon at the end of surgery,
      SABER® - Bupivacaine delivers a locally-acting pain reliever directly to the surgical wound.

      The purpose of this study is to measure how well it works in reducing pain after laparoscopic
      cholecystectomy (surgery to remove the gall bladder) and to investigate the safety of
      SABER®-Bupivacaine (its side effects).
    

Eligibility criteria:

        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.