Clinical trial NCT03859635: Erector Spinae Block Versus Surgeon Infiltration in VATS Procedures
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain, Postoperative
Thoracic
Acute Pain
Keywords: acute pain
VATS
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2019-03-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are randomized into one of three groups:

1. Ultrasound guided LB Erector Spinae Plane Block with 20ml of Exparel and 10ml 0.25% bupivacaine
2. Ultrasound guided SB Erector Spinae Plane Block with 30ml 0.5% bupivacaine
3. Surgeon Infiltration under video guidance with 20ml of Exparel and 10ml of 0.25% bupivacaine
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Pt undergoing VATS including but not limited to wedge or lobectomy 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.
* Pts. scheduled for a pleurodesis, decortication or esophagectomy at Indiana University Hospital

Primary outcomes:
measure: The Primary Endpoint of This Study Will be 24 Hours VAS Pain Score at Rest
timeFrame: 24 hours pain score at rest
measure: The Primary Endpoint of This Study Will be 24 Hours VAS Pain Score With Movement
timeFrame: 24 hours pain score with movement
measure: The Primary Endpoint of This Study Will be 48 Hours VAS Pain Score at Rest
timeFrame: 48 hours pain score at rest
measure: The Primary Endpoint of This Study Will be 48 Hours VAS Pain Score With Movement
timeFrame: 48 hours pain score with movement
Secondary outcomes:
measure: Secondary Endpoint Includes Total Opioid Consumption at 72 Hours
timeFrame: Opioid consumption will be measured at 72 hours post op. The total amount will be recorded.]
measure: Average Nausea Scores Over 72 Hours
timeFrame: Nausea scores will be documented at 1 hour post op, 24,48,and 72 hours after the block. The scores will then be averaged
measure: Average Sedation Scores Over 72 Hours
timeFrame: Sedation scores will be documented at 1 hour post op, 24,48,and 72 hours after the block. The scores will then be averaged.]
measure: Subjects Overall Satisfaction Scores at Hour 24
timeFrame: post operatively at hour 24
measure: Subjects Overall Satisfaction Scores at Hour 48
timeFrame: post operatively at hour 48
measure: Secondary Endpoint Includes Total Opioid Consumption at 48 Hours
timeFrame: Opioid consumption will be measured at 48 hours post op. The total amount will be recorded.]
measure: Secondary Endpoint Includes Total Opioid Consumption at 24 Hours
timeFrame: Opioid consumption will be measured at 24 hours post op. The total amount will be recorded.]
measure: Secondary Endpoint Includes Total Opioid Consumption at 1 Hour
timeFrame: Opioid consumption will be measured at 1 hour post op. The total amount will be recorded.]
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: Yar Yeap, MD
role: PRINCIPAL_INVESTIGATOR
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