Erector Spinae Block Versus Surgeon Infiltration in VATS Procedures
Condition: Pain, Postoperative; Thoracic; Acute Pain
MeSH terms: Pain, Postoperative; Acute Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is comparing the difference between erector spinae block and surgeon infiltration
      after VATS (Video Assisted Thoracoscopic Surgery). The outcomes measured are pain scores,
      opioid usage, opioid side effects, and patient satisfaction.We are also also studying the
      effectiveness of liposomal bupivacaine (EXPAREL) in a block by randomizing patients to both
      EXPAREL erector spinae block and simple bupivacaine erector spinae block.
    

Detailed description: 
      A total of 120 subjects will be randomized by a computer program into three groups (40 per
      group): The primary investigator will inform the anesthesiologist who will be doing the block
      as to what group the patients are randomized to. The research staff completing the patients
      assessments will be blinded to the randomization.

      For the LB group (Ultrasound guided LB Erector Spinae Plane Block), patients should receive a
      total of 10ml 0.25% bupivacaine plus 20ml Exparel® (15ml at T4 and 15ml at T8) For the SB
      group (Ultrasound guided SB Erector Spinae Plane Block), patients should receive a total of
      30ml 0.5% bupivacaine. (15ml at T4 and 15ml at T8) For the SI group (under video guidance)
      injected by surgeon using 10ml 0.25% bupivacaine plus 20ml Exparel

      All the erector spinae plane blocks will be placed preoperatively after sedation, before
      intubation and prior to surgery. All procedures will be placed under the supervision of the
      attending anesthesiologist on the acute pain service or the attending anesthesiologist in the
      operating room.

      For the ESP block, an ultrasound probe is used to visualize the ES musculature about 3 cm
      laterally from the spinous process. In a cephalad-to-caudad direction advance the needle and
      inject the anesthetic in the interfacial plane deep to the ES muscles. Confirm positioning by
      visualization of needle tip and elevation of ES muscles off the transverse process with
      anesthetic injection. Injection will be performed at T4 and T8 level.

      Surgeon infiltration is performed intraoperatively under direct thoracoscopic guidance. The
      intercostal space will be visualized and injected with LB. Typically, T4 through T8 are
      infiltrated with the anesthetic mixture.

      All patients will be placed on ERAS protocol, which is our standard of practice.

      Opioid usage after the block will be recorded by a member of the research team. Pain scores
      at rest and on movement (knee flexion) will be measured by the investigator using Visual
      Analog Scale (VAS). Nausea will be measured using a categorical scoring system (none=0;
      mild=1; moderate=2; severe=3). Sedation scores will also be assessed by a member of the study
      team using a sedation scale (awake and alert=0; quietly awake=1; asleep but easily roused=2;
      deep sleep=3). All these parameters will be measured at 1, 24, 48 and 72 hours after the
      surgery.

      All patients will receive a phone call 6 months after surgery for assessment for chronic
      post-surgical pain. Patients will be assessed by a member of the research team over the
      phone. They will be assessed on their pain score and narcotic usage by using the Brief Pain
      Inventory. Study participation will conclude after the 6 month follow questionnaire has been
      completed.
    

Intervention name(s): Liposomal Bupivacaine; Bupivacaine, 0.25%; Bupivacaine, 0.5%
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 20 ml; 10 ml; 30 ml
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients are randomized into one of three groups:
Ultrasound guided LB Erector Spinae Plane Block with 20ml of Exparel and 10ml 0.25% bupivacaine
Ultrasound guided SB Erector Spinae Plane Block with 30ml 0.5% bupivacaine
Surgeon Infiltration under video guidance with 20ml of Exparel and 10ml of 0.25% bupivacaine
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acute pain; VATS