Erector Spinae Block Versus Surgeon Infiltration in VATS Procedures

Indiana University

Status and phase: Completed; Phase 3

Conditions: Thoracic; Pain, Postoperative; Acute Pain

Treatments: Drug: Liposomal Bupivacaine; Drug: Bupivacaine, 0.25%; Drug: Bupivacaine, 0.5%

Study type: Interventional

Funder types: Other

Identifiers

NCT03859635

1809656804

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Ultrasound guided Liposomal Bupivacaine Erector Spinae Block

Active Comparator group

Description:

All the erector spinae plane blocks will be placed preoperatively using Liposomal Buvicaine. 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.

Treatment:

Drug: Bupivacaine, 0.25%

Drug: Liposomal Bupivacaine

Ultrasound guided Standard Bupivacaine Erector Spinae Block

Active Comparator group

Description:

All the erector spinae plane blocks will be placed preoperatively using Liposomal Buvicaine. 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.

Treatment:

Drug: Bupivacaine, 0.5%

Surgeon Infiltration

Active Comparator group

Description:

At the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8.

Treatment:

Drug: Bupivacaine, 0.25%

Drug: Liposomal Bupivacaine