Exparel vs. Bupivacaine Hydrochloride vs. Placebo for Hernia Repair
Condition: Analgesia, Postoperative
MeSH terms: Hernia
Intervention: Exparel; Bupivacaine Hcl 0.25% Inj; Placebo
Intervention description: Solution of: 266mg of Bupivacaine Liposome Injectable Suspension (Exparel) mixed with 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block; Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block; Normal saline administered intraoperatively through a transversus abdominis plane (TAP) block
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 164.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Liposomal Bupivacaine; Exparel; Transversus Abdominis Plane block; Hernia

Summary:

      Patients usually experience some level of pain after their hernia repair. To control pain
      after the operation, surgeons have many options. One of them is to make some injections of
      pain blocker medications into the nerves that are responsible for the sensations the
      abdominal wall.This procedure is called TAP block (transversus abdominis place block). These
      medications are called local anesthetics, and there is a variety of medications that can be
      used. One of such medications is called Exparel® (Liposomal Bupivacaine). Exparel® has the
      potential benefit of lasting more hours than regular anesthetics. Although this drug is being
      used with increasing frequency, the investigators do not have good quality studies
      investigating the benefits of using this medication during a hernia repair, especially when
      compared to other types of local anesthetics (Bupivacaine Hydrochloride) or when compared to
      not injecting this medication at all. This study aim to investigate if Exparel®, when
      injected in the nerves of the abdominal wall during hernia repair can: (1) reduce the dose of
      additional opioid medications (morphine and similar) needed to achieve good pain control and
      (2) result in lower pain scores. The hypothesis is that Exparel® will result in a 30%
      decrease in the total requirements for opioid medications during the first 72 hours after
      surgery. Patients will be randomized to receive either Exparel®+Bupivacaine Hydrochloride,
      Bupivacaine Hydrochloride or Placebo (normal saline) during the operation through a TAP
      block. All patients will receive a patient controlled analgesia device after the operation,
      where patients can simply push a button every time they feel pain and the device will
      administer a dose of opioid medications. The investigators of the study will record the
      necessary amount of opioids used by the patients to achieve good pain control and also record
      pain scores several times during hospital stay.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with Primary Ventral or Incisional Hernias

          -  Scheduled to undergo hernia repair through an open approach

          -  Hernia repair performed in an elective setting

          -  Hernia repair performed through a midline incision

          -  Hernia repair performed in a clean wound

          -  Hernia repair performed with mesh placed in the retromuscular position

        Exclusion Criteria:

          -  patients with less than 18 years old of age

          -  patients scheduled to undergo a minimally invasive hernia repair

          -  patients where hernia repair is planned to be performed with mesh placement in a
             different position than retromuscular

          -  patient undergoing hernia repair with a clean-contaminated, contaminated or infected
             wound

          -  patients undergoing hernia repair in an non-elective fashion

          -  patients with allergy, hypersensitivity or contraindication to bupivacaine

          -  patients with history of chronic liver disease with moderate or severe impairment in
             liver function defined as a Child-Pugh class B or C

          -  patients with chronic kidney disease on dialysis

          -  chronic opioid users, defined as daily or near daily use of opioids for at least 90
             days in the past year

          -  patients unable to provide informed written consent