Erector Spinae Block Versus Surgeon Infiltration in VATS Procedures

Phase 3

Completed

Conditions: Pain, Postoperative
Thoracic
Acute Pain

Interventions: Drug: Liposomal Bupivacaine
Drug: Bupivacaine, 0.5%
Drug: Bupivacaine, 0.25%

Registration Number: NCT03859635

Lead Sponsor: Indiana University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 120

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

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgeon Infiltration	Bupivacaine, 0.25%	At the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8.
Surgeon Infiltration	Liposomal Bupivacaine	At the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8.
Ultrasound guided Liposomal Bupivacaine Erector Spinae Block	Liposomal Bupivacaine	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.
Ultrasound guided Liposomal Bupivacaine Erector Spinae Block	Bupivacaine, 0.25%	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.
Ultrasound guided Standard Bupivacaine Erector Spinae Block	Bupivacaine, 0.5%	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.

Primary Outcome Measures

Name	Time	Method
The Primary Endpoint of This Study Will be 24 Hours VAS Pain Score at Rest	24 hours pain score at rest	The VAS score will be taken at rest using Visual Analog Scale (VAS). Using a scale of 0-10 for documentation with 10 being the worst pain and 0 being no pain
The Primary Endpoint of This Study Will be 24 Hours VAS Pain Score With Movement	24 hours pain score with movement	The VAS score will be taken after movement (knee flexion) using Visual Analog Scale (VAS). Using a scale of 0-10 for documentation with 10 being the worst pain and 0 being no pain
The Primary Endpoint of This Study Will be 48 Hours VAS Pain Score at Rest	48 hours pain score at rest	The VAS score will be taken at rest using Visual Analog Scale (VAS). Using a scale of 0-10 for documentation with 10 being the worst pain and 0 being no pain
The Primary Endpoint of This Study Will be 48 Hours VAS Pain Score With Movement	48 hours pain score with movement	The VAS score will be taken after movement (knee flexion) using Visual Analog Scale (VAS). Using a scale of 0-10 for documentation with 10 being the worst pain and 0 being no pain

Secondary Outcome Measures

Name	Time	Method
Secondary Endpoint Includes Total Opioid Consumption at 72 Hours	Opioid consumption will be measured at 72 hours post op. The total amount will be recorded.]	Opioid consumption between 48-72hr will be collected by a study team member per protocol time requirements
Average Nausea Scores Over 72 Hours	Nausea scores will be documented at 1 hour post op, 24,48,and 72 hours after the block. The scores will then be averaged	Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as None=0, Mild=1, Moderate=2, Severe=3.
Average Sedation Scores Over 72 Hours	Sedation scores will be documented at 1 hour post op, 24,48,and 72 hours after the block. The scores will then be averaged.]	Sedation scores will be documented by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is Awake/Alert=0, Quietly Awake=1, Asleep but Arousable=2, or Deep Sleep=3
Subjects Overall Satisfaction Scores at Hour 24	post operatively at hour 24	Subjects will be followed up at 24 hours post operatively by a study team member to document patient overall satisfaction scores. The scores are collected as Very Unsatisfied=0, Unsatisfied=1, Neutral=2, Satisfied=3, Very Satisfied=4
Subjects Overall Satisfaction Scores at Hour 48	post operatively at hour 48	Subjects will be followed up at 48 hours post operatively by a study team member to document patient overall satisfaction scores. The scores are collected as Very Unsatisfied=0, Unsatisfied=1, Neutral=2, Satisfied=3, Very Satisfied=4
Secondary Endpoint Includes Total Opioid Consumption at 48 Hours	Opioid consumption will be measured at 48 hours post op. The total amount will be recorded.]	Opioid consumption at 24-48hr post op will be collected by a study team member per protocol time requirements
Secondary Endpoint Includes Total Opioid Consumption at 24 Hours	Opioid consumption will be measured at 24 hours post op. The total amount will be recorded.]	Opioid consumption at 1-24 hr postop will be collected by a study team member per protocol time requirements
Secondary Endpoint Includes Total Opioid Consumption at 1 Hour	Opioid consumption will be measured at 1 hour post op. The total amount will be recorded.]	Opioid consumption at 1hr will be collected by a study team member per protocol time requirements