Erector Spinae Block Versus Surgeon Infiltration in VATS Procedures



Status:Recruiting
Conditions:Chronic Pain, Post-Surgical Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - 100
Updated:3/3/2019
Start Date:February 7, 2019
End Date:June 1, 2021
Contact:Lyla S Farlow, LPN
Email:lychrist@iupui.edu
Phone:317-948-9804

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Randomized Prospective Study Comparing Exparel Erector Spinae Plane Block vs Simple Bupivacaine Erector Spinae Plane Block vs Exparel Surgeon Infiltration for Postoperative Analgesia Following Video-assisted Thoracoscopic Surgery

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.

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.

Inclusion Criteria:

- Pt undergoing VATS (including but not limited to wedge, lobectomy, pleurodesis,
decortication, esophagectomy) at Indiana University Hospital

- ASA 1,2,3 or 4

- Age 18 or older, male or female

- Desires regional anesthesia for postoperative pain control

Exclusion criteria:

- Any contraindication for Erector Spinae Plane block

- History of substance abuse in the past 6 months which would include heroin, marijuana
or any other illegal street drugs

- Patient staying intubated after surgery

- Patient (home dose) taking more than 30mg PO morphine equivalent per day

- Known allergy or other contraindications to the study medications, which include
dilaudid and bupivacaine.
We found this trial at
1
site
550 University Boulevard
Indianapolis, Indiana 46202
Phone: 317-274-0275
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mi
from
Indianapolis, IN
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