Trial Outcomes & Findings for Erector Spinae Block Versus Surgeon Infiltration in VATS Procedures (NCT NCT03859635)

NCT ID: NCT03859635

Last Updated: 2025-02-28

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 120 participants
• Primary outcome timeframe: 48 hours pain score with movement
• Results posted on: 2025-02-28

Participant Flow

Participant milestones

Measure	Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block 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. Liposomal Bupivacaine: 20 ml Bupivacaine, 0.25%: 10 ml	Ultrasound Guided Standard Bupivacaine Erector Spinae Block 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. Bupivacaine, 0.5%: 30 ml	Surgeon Infiltration At the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8. Liposomal Bupivacaine: 20 ml Bupivacaine, 0.25%: 10 ml
Overall Study STARTED	40	40	40
Overall Study COMPLETED	37	35	33
Overall Study NOT COMPLETED	3	5	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block n=37 Participants 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. Liposomal Bupivacaine: 20 ml Bupivacaine, 0.25%: 10 ml	Ultrasound Guided Standard Bupivacaine Erector Spinae Block n=35 Participants 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. Bupivacaine, 0.5%: 30 ml	Surgeon Infiltration n=33 Participants At the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8. Liposomal Bupivacaine: 20 ml Bupivacaine, 0.25%: 10 ml	Total n=105 Participants Total of all reporting groups
Age, Continuous	63 years STANDARD_DEVIATION 9 • n=37 Participants	64 years STANDARD_DEVIATION 10 • n=35 Participants	66 years STANDARD_DEVIATION 12 • n=33 Participants	64 years STANDARD_DEVIATION 10 • n=105 Participants
Sex: Female, Male Female	19 Participants n=37 Participants	26 Participants n=35 Participants	15 Participants n=33 Participants	60 Participants n=105 Participants
Sex: Female, Male Male	18 Participants n=37 Participants	9 Participants n=35 Participants	18 Participants n=33 Participants	45 Participants n=105 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
weight	76.44 weight in kg STANDARD_DEVIATION 19.02 • n=37 Participants	79.59 weight in kg STANDARD_DEVIATION 16.11 • n=35 Participants	86.19 weight in kg STANDARD_DEVIATION 15.33 • n=33 Participants	80.56 weight in kg STANDARD_DEVIATION 17.29 • n=105 Participants
BMI	25.90 Body Mass Index in kg/m^2 STANDARD_DEVIATION 5.57 • n=37 Participants	28.81 Body Mass Index in kg/m^2 STANDARD_DEVIATION 4.72 • n=35 Participants	29.89 Body Mass Index in kg/m^2 STANDARD_DEVIATION 4.89 • n=33 Participants	28.13 Body Mass Index in kg/m^2 STANDARD_DEVIATION 5.32 • n=105 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block n=37 Participants 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. Liposomal Bupivacaine: 20 ml Bupivacaine, 0.25%: 10 ml	Ultrasound Guided Standard Bupivacaine Erector Spinae Block n=35 Participants 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. Bupivacaine, 0.5%: 30 ml	Surgeon Infiltration n=33 Participants At the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8. Liposomal Bupivacaine: 20 ml Bupivacaine, 0.25%: 10 ml
The Primary Endpoint of This Study Will be 24 Hours VAS Pain Score at Rest	4.1 score on a scale Standard Deviation 2.5	4.3 score on a scale Standard Deviation 2.6	3.3 score on a scale Standard Deviation 2.3

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block n=37 Participants 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. Liposomal Bupivacaine: 20 ml Bupivacaine, 0.25%: 10 ml	Ultrasound Guided Standard Bupivacaine Erector Spinae Block n=35 Participants 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. Bupivacaine, 0.5%: 30 ml	Surgeon Infiltration n=33 Participants At the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8. Liposomal Bupivacaine: 20 ml Bupivacaine, 0.25%: 10 ml
The Primary Endpoint of This Study Will be 24 Hours VAS Pain Score With Movement	6.0 score on a scale Standard Deviation 2.8	6.3 score on a scale Standard Deviation 2.3	4.5 score on a scale Standard Deviation 2.9

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block n=37 Participants 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. Liposomal Bupivacaine: 20 ml Bupivacaine, 0.25%: 10 ml	Ultrasound Guided Standard Bupivacaine Erector Spinae Block n=35 Participants 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. Bupivacaine, 0.5%: 30 ml	Surgeon Infiltration n=33 Participants At the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8. Liposomal Bupivacaine: 20 ml Bupivacaine, 0.25%: 10 ml
The Primary Endpoint of This Study Will be 48 Hours VAS Pain Score at Rest	3.1 score on a scale Standard Deviation 2.3	3.4 score on a scale Standard Deviation 2.5	2.8 score on a scale Standard Deviation 2.1

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block n=37 Participants 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. Liposomal Bupivacaine: 20 ml Bupivacaine, 0.25%: 10 ml	Ultrasound Guided Standard Bupivacaine Erector Spinae Block n=35 Participants 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. Bupivacaine, 0.5%: 30 ml	Surgeon Infiltration n=33 Participants At the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8. Liposomal Bupivacaine: 20 ml Bupivacaine, 0.25%: 10 ml
The Primary Endpoint of This Study Will be 48 Hours VAS Pain Score With Movement	4.6 score on a scale Standard Deviation 2.6	5.3 score on a scale Standard Deviation 2.4	3.8 score on a scale Standard Deviation 2.6

SECONDARY outcome

Timeframe: Opioid consumption will be measured at 72 hours post op. The total amount will be recorded.]

Population: Total of 120 patients consented for the study. 15 patients were excluded from the study, leaving a total of 105 patients at study completion.

Opioid consumption between 48-72hr will be collected by a study team member per protocol time requirements

Outcome measures

Measure	Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block n=37 Participants 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. Liposomal Bupivacaine: 20 ml Bupivacaine, 0.25%: 10 ml	Ultrasound Guided Standard Bupivacaine Erector Spinae Block n=35 Participants 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. Bupivacaine, 0.5%: 30 ml	Surgeon Infiltration n=33 Participants At the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8. Liposomal Bupivacaine: 20 ml Bupivacaine, 0.25%: 10 ml
Secondary Endpoint Includes Total Opioid Consumption at 72 Hours	26 mg morphine equivalant/day Interval 18.0 to 68.0	48 mg morphine equivalant/day Interval 28.0 to 72.0	40 mg morphine equivalant/day Interval 20.0 to 136.0

SECONDARY outcome

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

Population: Total of 120 patients consented for the study. 15 patients were excluded from the study, leaving a total of 105 patients at study completion.

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.

Outcome measures

Measure	Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block n=37 Participants 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. Liposomal Bupivacaine: 20 ml Bupivacaine, 0.25%: 10 ml	Ultrasound Guided Standard Bupivacaine Erector Spinae Block n=35 Participants 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. Bupivacaine, 0.5%: 30 ml	Surgeon Infiltration n=33 Participants At the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8. Liposomal Bupivacaine: 20 ml Bupivacaine, 0.25%: 10 ml
Average Nausea Scores Over 72 Hours	0.14 units on a scale Interval 0.0 to 3.0	0.14 units on a scale Interval 0.0 to 2.0	0.06 units on a scale Interval 0.0 to 2.0

SECONDARY outcome

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.]

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

Outcome measures

Measure	Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block n=37 Participants 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. Liposomal Bupivacaine: 20 ml Bupivacaine, 0.25%: 10 ml	Ultrasound Guided Standard Bupivacaine Erector Spinae Block n=35 Participants 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. Bupivacaine, 0.5%: 30 ml	Surgeon Infiltration n=33 Participants At the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8. Liposomal Bupivacaine: 20 ml Bupivacaine, 0.25%: 10 ml
Average Sedation Scores Over 72 Hours	0.08 units on a scale Interval 0.0 to 2.0	0.03 units on a scale Interval 0.0 to 1.0	0 units on a scale Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block n=37 Participants 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. Liposomal Bupivacaine: 20 ml Bupivacaine, 0.25%: 10 ml	Ultrasound Guided Standard Bupivacaine Erector Spinae Block n=35 Participants 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. Bupivacaine, 0.5%: 30 ml	Surgeon Infiltration n=33 Participants At the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8. Liposomal Bupivacaine: 20 ml Bupivacaine, 0.25%: 10 ml
Subjects Overall Satisfaction Scores at Hour 24	3.5 units on a scale Interval 3.0 to 4.0	4 units on a scale Interval 1.0 to 4.0	3 units on a scale Interval 2.0 to 4.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block n=37 Participants 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. Liposomal Bupivacaine: 20 ml Bupivacaine, 0.25%: 10 ml	Ultrasound Guided Standard Bupivacaine Erector Spinae Block n=35 Participants 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. Bupivacaine, 0.5%: 30 ml	Surgeon Infiltration n=33 Participants At the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8. Liposomal Bupivacaine: 20 ml Bupivacaine, 0.25%: 10 ml
Subjects Overall Satisfaction Scores at Hour 48	3 units on a scale Interval 2.0 to 4.0	4 units on a scale Interval 1.0 to 4.0	4 units on a scale Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: Opioid consumption will be measured at 48 hours post op. The total amount will be recorded.]

Population: Total of 120 patients consented for the study. 15 patients were excluded from the study, leaving a total of 105 patients at study completion.

Opioid consumption at 24-48hr post op will be collected by a study team member per protocol time requirements

Outcome measures

Measure	Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block n=37 Participants 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. Liposomal Bupivacaine: 20 ml Bupivacaine, 0.25%: 10 ml	Ultrasound Guided Standard Bupivacaine Erector Spinae Block n=35 Participants 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. Bupivacaine, 0.5%: 30 ml	Surgeon Infiltration n=33 Participants At the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8. Liposomal Bupivacaine: 20 ml Bupivacaine, 0.25%: 10 ml
Secondary Endpoint Includes Total Opioid Consumption at 48 Hours	48 mg morphine equivalant/day Interval 16.0 to 88.0	34 mg morphine equivalant/day Interval 22.0 to 76.0	60 mg morphine equivalant/day Interval 28.0 to 80.0

SECONDARY outcome

Timeframe: Opioid consumption will be measured at 24 hours post op. The total amount will be recorded.]

Population: Total of 120 patients consented for the study. 15 patients were excluded from the study, leaving a total of 105 patients at study completion.

Opioid consumption at 1-24 hr postop will be collected by a study team member per protocol time requirements

Outcome measures

Measure	Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block n=37 Participants 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. Liposomal Bupivacaine: 20 ml Bupivacaine, 0.25%: 10 ml	Ultrasound Guided Standard Bupivacaine Erector Spinae Block n=35 Participants 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. Bupivacaine, 0.5%: 30 ml	Surgeon Infiltration n=33 Participants At the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8. Liposomal Bupivacaine: 20 ml Bupivacaine, 0.25%: 10 ml
Secondary Endpoint Includes Total Opioid Consumption at 24 Hours	38 mg morphine equivalant/day Interval 18.0 to 62.0	40 mg morphine equivalant/day Interval 24.0 to 96.0	36 mg morphine equivalant/day Interval 20.0 to 68.0

SECONDARY outcome

Timeframe: Opioid consumption will be measured at 1 hour post op. The total amount will be recorded.]

Population: Total of 120 patients consented for the study. 15 patients were excluded from the study, leaving a total of 105 patients at study completion.

Opioid consumption at 1hr will be collected by a study team member per protocol time requirements

Outcome measures

Measure	Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block n=37 Participants 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. Liposomal Bupivacaine: 20 ml Bupivacaine, 0.25%: 10 ml	Ultrasound Guided Standard Bupivacaine Erector Spinae Block n=35 Participants 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. Bupivacaine, 0.5%: 30 ml	Surgeon Infiltration n=33 Participants At the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8. Liposomal Bupivacaine: 20 ml Bupivacaine, 0.25%: 10 ml
Secondary Endpoint Includes Total Opioid Consumption at 1 Hour	16 mg morphine equivalant Interval 8.0 to 20.0	12 mg morphine equivalant Interval 8.0 to 20.0	8 mg morphine equivalant Interval 4.0 to 16.0

Adverse Events

Ultrasound Guided Loposomal Erector Spinae Block

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Ultrasound Guided Standard Bupivacaine Erector Spinae Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Surgeon Infiltration

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ultrasound Guided Loposomal Erector Spinae Block n=37 participants at risk Group 1-Ultrasound guided Liposomal Erector Spinae Block	Ultrasound Guided Standard Bupivacaine Erector Spinae Block n=35 participants at risk Group-2-Ultrasound guided Standard Bupivacaine Erector Spinae Block	Surgeon Infiltration n=33 participants at risk Group 3-Surgeon Infiltration
Gastrointestinal disorders Ileus	2.7% 1/37 • Number of events 1 • Any adverse events from day of surgery til 6 months after surgery are documented..	0.00% 0/35 • Any adverse events from day of surgery til 6 months after surgery are documented..	3.0% 1/33 • Number of events 33 • Any adverse events from day of surgery til 6 months after surgery are documented..
Respiratory, thoracic and mediastinal disorders Respiratory Depression	0.00% 0/37 • Any adverse events from day of surgery til 6 months after surgery are documented..	0.00% 0/35 • Any adverse events from day of surgery til 6 months after surgery are documented..	3.0% 1/33 • Number of events 33 • Any adverse events from day of surgery til 6 months after surgery are documented..

Additional Information

Yar Luan Yeap, MD

Indiana University Department of Anesthesiology

Phone: 3172740275

Email: yyeap@iu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place