NCT03859635

Erector Spinae Block Versus Surgeon Infiltration in VATS Procedures

Completed Phase 3 Results posted Last updated 28 February 2025

What this trial tests

Phase 3 trial testing Liposomal Bupivacaine in Pain, Postoperative in 120 participants. Completed in 7 November 2022.

Timeline

7 February 2019

Primary endpoint
6 November 2022

7 November 2022

Quick facts

Lead sponsor	Indiana University
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	120
Start date	7 February 2019
Primary completion	6 November 2022
Estimated completion	7 November 2022
Sites	1 location across United States

Drugs / interventions tested

• Liposomal Bupivacaine — full drug profile →
• Bupivacaine, 0.25%
• Bupivacaine, 0.5%

Conditions studied

• Pain, Postoperative — all drugs for Pain, Postoperative →
• Thoracic — all drugs for Thoracic →
• Acute Pain — all drugs for Acute Pain →

Sponsor

Indiana University

Who can join

Adults 18 to 100, any sex, with Pain, Postoperative or Thoracic. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Primary Endpoint of This Study Will be 24 Hours VAS Pain Score at Rest Primary · 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

Group	Value	95% CI
Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block	4.1	± 2.5
Ultrasound Guided Standard Bupivacaine Erector Spinae Block	4.3	± 2.6
Surgeon Infiltration	3.3	± 2.3

The Primary Endpoint of This Study Will be 24 Hours VAS Pain Score With Movement Primary · 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

Group	Value	95% CI
Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block	6.0	± 2.8
Ultrasound Guided Standard Bupivacaine Erector Spinae Block	6.3	± 2.3
Surgeon Infiltration	4.5	± 2.9

The Primary Endpoint of This Study Will be 48 Hours VAS Pain Score at Rest Primary · 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

Group	Value	95% CI
Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block	3.1	± 2.3
Ultrasound Guided Standard Bupivacaine Erector Spinae Block	3.4	± 2.5
Surgeon Infiltration	2.8	± 2.1

Secondary Endpoint Includes Total Opioid Consumption at 72 Hours Secondary · 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

Group	Value	95% CI
Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block	26	18 – 68
Ultrasound Guided Standard Bupivacaine Erector Spinae Block	48	28 – 72
Surgeon Infiltration	40	20 – 136

Average Nausea Scores Over 72 Hours Secondary · 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.

Group	Value	95% CI
Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block	0.14	0 – 3
Ultrasound Guided Standard Bupivacaine Erector Spinae Block	0.14	0 – 2
Surgeon Infiltration	0.06	0 – 2

Average Sedation Scores Over 72 Hours Secondary · 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

Group	Value	95% CI
Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block	0.08	0 – 2
Ultrasound Guided Standard Bupivacaine Erector Spinae Block	0.03	0 – 1
Surgeon Infiltration	0	0 – 0

Subjects Overall Satisfaction Scores at Hour 24 Secondary · 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

Group	Value	95% CI
Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block	3.5	3 – 4
Ultrasound Guided Standard Bupivacaine Erector Spinae Block	4	1 – 4
Surgeon Infiltration	3	2 – 4

Subjects Overall Satisfaction Scores at Hour 48 Secondary · 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

Group	Value	95% CI
Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block	3	2 – 4
Ultrasound Guided Standard Bupivacaine Erector Spinae Block	4	1 – 4
Surgeon Infiltration	4	1 – 4

Secondary Endpoint Includes Total Opioid Consumption at 48 Hours Secondary · 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

Group	Value	95% CI
Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block	48	16 – 88
Ultrasound Guided Standard Bupivacaine Erector Spinae Block	34	22 – 76
Surgeon Infiltration	60	28 – 80

Secondary Endpoint Includes Total Opioid Consumption at 24 Hours Secondary · 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

Group	Value	95% CI
Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block	38	18 – 62
Ultrasound Guided Standard Bupivacaine Erector Spinae Block	40	24 – 96
Surgeon Infiltration	36	20 – 68

Secondary Endpoint Includes Total Opioid Consumption at 1 Hour Secondary · 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

Group	Value	95% CI
Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block	16	8 – 20
Ultrasound Guided Standard Bupivacaine Erector Spinae Block	12	8 – 20
Surgeon Infiltration	8	4 – 16

The Primary Endpoint of This Study Will be 48 Hours VAS Pain Score With Movement Primary · 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

Group	Value	95% CI
Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block	4.6	± 2.6
Ultrasound Guided Standard Bupivacaine Erector Spinae Block	5.3	± 2.4
Surgeon Infiltration	3.8	± 2.6

Adverse events — posted to ClinicalTrials.gov

Time frame: Any adverse events from day of surgery til 6 months after surgery are documented... Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Ultrasound Guided Loposomal Erector Spinae Block

Serious: 0/37 (0%)

Deaths: 0/37

Ultrasound Guided Standard Bupivacaine Erector Spinae Block

Serious: 0/35 (0%)

Deaths: 0/35

Surgeon Infiltration

Serious: 0/33 (0%)

Deaths: 0/33

Other adverse events (2 terms — click to expand)

Reaction	System	Ultrasound Guided Loposoma…	Ultrasound Guided Standard…	Surgeon Infiltration
Ileus	Gastrointestinal disorders	—	—	—
Respiratory Depression	Respiratory, thoracic and mediastinal disorders	—	—	—

Data from ClinicalTrials.gov NCT03859635 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.