Exparel vs. Standard Bupivicaine for Abdominoplasty
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Liposomal Injection Bupivacaine (Exparel); Standard bupivicaine
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pain, Postoperative; Analgesia; Anesthesia, local; Abdominoplasty

Summary:

      Background & study question:

      Strategies for post-operative pain control that make use of various different types of
      medicines are advantageous both for patient comfort and for minimizing the use of opioid pain
      medicines and their associated side effects, which include drowsiness, nausea, and vomiting.
      A key element of these strategies is wound injection with local anesthetic (numbing medicine)
      at the time of surgery. Local numbing procedures are used routinely in patients undergoing
      abdominoplasty (tummy tuck), most often with lidocaine or bupivacaine, which can last several
      hours. Multiple studies have shown that locally injected pain medicines achieve better pain
      control, less opioid use, and faster return to normal activities, such that the use of one of
      these local anesthetic medicines is the current standard of care.

      Exparel is an extended-release formulation of bupivacaine that can produce local pain relief
      for up to 72 hours. Studies have shown it to provide better post-operative pain control and
      decreased use of opioid medications when compared to patients who did not receive any local
      numbing agents. Exparel has been used successfully in a variety of surgical settings,
      including open colon surgery, laparoscopic gall bladder removal, abdominoplasty, and breast
      augmentation. Its effectiveness has by and large been established in comparison to no local
      anesthetic. In this study, we seek to investigate the benefit of Exparel compared to standard
      bupivacaine infiltration in patients undergoing abdominoplasty.

      Study design:

      Patients scheduled for abdominoplasty with the lead investigator will be offered inclusion in
      this study. Consenting patients will be randomly assigned to standard bupivacaine or Exparel
      by coin toss after their clinic visit. On the day of surgery, the only difference between
      patients assigned to one arm or the other is the local anesthetic used. The surgery itself
      and plan for general anesthesia will be similar. Both groups will have the same pain
      medicines available after surgery.

      Patients will be given a form on which to record twice-daily pain ratings and opioid narcotic
      needs for 3 days after surgery. For patients admitted after surgery, oral and IV narcotic use
      will be collected from their inpatient medical record.

      The primary outcome of interest is daily and cumulative pain scores through 3 days. A
      secondary endpoint is daily and total opioid use over 3 days. Additional measures include the
      time to first post-operative use of opioid medication and incidence of any adverse side
      effects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult men and women

          -  scheduled for abdominoplasty

        Exclusion Criteria:

          -  pregnant women

          -  patients with allergy to amide-type local anesthetics