Erector Spinae Versus Paravertebral Nerve Blocks for Breast Surgery
Condition: Breast Surgery
Intervention: Erector Spinae (single injection); Paravertebral (single injection)
Intervention description: Ropivacaine 0.5% (with epinephrine 1:200,000-400,000) will be administered via the needle into the target plane.; Ropivacaine 0.5% (with epinephrine 1:200,000-400,000) will be administered via the needle into the target plane.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Regional anesthesia; Paravertebral; Erector spinae; Nerve block

Summary:

      Following painful surgical procedures of the breast, postoperative analgesia is often
      provided with a paravertebral nerve block (PVB). For intense, but shorter-duration acute
      pain, a single-injection of local anesthetic is used with a duration of approximately 12
      hours. The PVB has several limitations: it can decrease blood pressure, and very rare-but
      serious-complications have occurred, including neuraxial injection, neuraxial hematoma, and
      pleural puncture. An alternative block has been described: the erector spinae plane block.
      The theoretical benefits include ease of administration since it is a plane superficial to
      the PVB and therefore easier to identify and target with ultrasound (therefore increasing
      success rate); and an increased safety margin: there are few anatomic structures in the
      immediate area which could be injured with the needle; and, the target plane is much further
      from the intrathecal/epidural space relative to the PVB. Lastly, the plane may be easier to
      catheterize for continuous peripheral nerve blocks relative to the relatively-small volume
      PVB.

      There are therefore multiple theoretical reasons to prefer the erector spinae plane block.
      Unfortunately, it remains unknown if the analgesia provided by this new technique is
      comparable to that provided with the PVB. The investigators therefore propose to compare
      these two techniques with a randomized, subject-masked, active-controlled, parallel-arm,
      human subjects clinical trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  undergoing unilateral or bilateral breast surgery with at least moderate postoperative
             pain anticipated

          -  analgesic plan includes a single-injection peripheral nerve block(s)

          -  age 18 years or older.

        Exclusion Criteria:

          -  morbid obesity as defined by a body mass index > 40 (BMI=weight in kg / [height in
             meters]2)

          -  renal insufficiency (preoperative creatinine > 1.5 mg/dL)

          -  chronic opioid use (daily use within the 2 weeks prior to surgery and duration of use
             > 4 weeks)

          -  history of opioid abuse

          -  any comorbidity which results in moderate or severe functional limitation

          -  inability to communicate with the investigators or hospital staff

          -  pregnancy

          -  planned regional analgesic with perineural catheter placement

          -  incarceration