Obstetric Liposomal Bupivacaine Via Surgical Transversus Abdominis Plane Block for Post Cesarean Pain Control
Condition: Cesarean Section Complications; Pain; Opioid Use
Intervention: Liposomal bupivacaine; Bupivacaine Hydrochloride; saline
Intervention description: 20 mL prior to closing fascia, the active drug (bupivacaine) is encapsulated in a liposomal platform and released slowly over the course of days with an approximate 72 hour duration.; 30 mL bupivacaine hydrochloride 0.25 percent, local post-surgical anesthetic; post-surgical saline
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 60.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: cesarean

Summary:

      This study seeks to identify whether the addition of liposomal bupivacaine to regular
      bupivacaine and saline administered via surgical transversus abdominis plane (TAP) block will
      reduce the cumulative opioid dose in the first 48 hours after cesarean. 60 women scheduled
      for cesarean at Unity-Point Health Meriter Hospital in Madison, Wisconsin will be enrolled
      and can be expect to be on study for up to 6 weeks post-partum.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Maternal age greater than or equal to 18

          -  Singleton or multifetal pregnancy

          -  Able to receive neuraxial analgesia

          -  Planned/ scheduled Cesarean delivery OR non-urgent Cesarean delivery at
             UnityPoint-Health Meriter with adequate time to consider and consent to the study

          -  Able to provide consent in English

        Exclusion Criteria:

          -  Known hypersensitivity to bupivacaine (defined as a history of a reaction or allergy
             to bupivacaine (injectable, intravenous, or transdermal) reported by patient or
             documented in the medical record

          -  Contraindication to regional analgesia

          -  Positive urine drug screen at admission to the hospital, if ordered for clinical
             purposes.

          -  Current opioid use or opioid use disorder per patient report or documented in the
             medical record

          -  Chronic opioid use or opioid use disorder, either patient reported or documented in
             the medical record, defined as opioid use on most days for greater than 3 months

          -  Planned cesarean hysterectomy (excluded due to anticipated blood loss and alternative
             pain control measures, possible prolonged intubation)

          -  Planned vertical midline incision (excluded due to possible different postpartum pain)

          -  Presence of renal dysfunction precluding the use of NSAIDs (NSAIDs are part of the
             usual postpartum pain regimen/ hospital protocol) per discretion of the treating
             physician or PI

          -  Ischemic heart disease, congestive heart failure, or cardiomyopathy of pregnancy
             precluding the use of NSAIDs (NSAIDs are part of the usual postpartum pain regimen/
             hospital protocol) per discretion of the treating physician or PI

          -  Significant liver dysfunction precluding the use of acetaminophen (acetaminophen is
             part of the usual postpartum pain regimen/ hospital protocol) per discretion of the
             treating physician or PI

          -  Coagulopathy

          -  Planned discharge from the hospital less than 48 hours postpartum

          -  Unable to receive post-operative scheduled acetaminophen for any reason, such as
             allergy to acetaminophen or elevated liver function tests precluding acetaminophen use

          -  Unable to receive post-operative scheduled NSAIDs for any reason, such as allergy to
             ketorolac or ibuprofen, or renal dysfunction precluding NSAID use

          -  Seizure disorder: Specifically, poorly controlled seizure disorder defined as having
             had a seizure within the last three years despite antiepileptic use or poorly managed
             seizure disorder due to medication non-compliance.

          -  Cardiac disease or arrhythmia: Defined as ischemic heart disease, peripartum
             cardiomyopathy, heart failure (with reduced or preserved ejection fraction,
             compensated or decompensated). Patients with a remote history of non-cyanotic
             pediatric cardiac surgery (like a VSD closure or PDA ligation as a child) do not need
             to be excluded. History of adult cardiac surgery without ongoing problems or
             treatments other than chronic anticoagulation (mitral valve repair for MVP or aortic
             valve replacement for bicuspid aortic valve for example) would not need to be
             excluded. History of repaired congenital cyanotic heart disease should be considered
             for exclusion, ultimately up to the anesthesiologist that day. A patient with a
             history of arrhythmias not requiring medication or ablation would NOT need to be
             excluded and could be included in the study. History of ablation or active
             anti-arrhythmic medication should be considered for exclusion.

          -  Hypoxia: Defined as requiring supplemental oxygen during the day.

          -  Acidosis. This will be uncommon in our population, but if someone has active diabetic
             ketoacidosis will exclude.