Phase 3
N=120
Erector Spinae Block Versus Surgeon Infiltration in VATS Procedures
Pain, Postoperative · Thoracic · Acute Pain
Bottom Line
View on ClinicalTrials.gov: NCT03859635 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: The Primary Endpoint of This Study Will be 24 Hours VAS Pain Score at Rest — 4.1; 4.3; 3.3 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Liposomal Bupivacaine (Drug); Bupivacaine, 0.25% (Drug); Bupivacaine, 0.5% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Endpoint of This Study Will be 24 Hours VAS Pain Score at Rest |
4.1; 4.3; 3.3 | — |
| PRIMARY The Primary Endpoint of This Study Will be 24 Hours VAS Pain Score With Movement |
6.0; 6.3; 4.5 | — |
| PRIMARY The Primary Endpoint of This Study Will be 48 Hours VAS Pain Score at Rest |
3.1; 3.4; 2.8 | — |
| PRIMARY The Primary Endpoint of This Study Will be 48 Hours VAS Pain Score With Movement |
4.6; 5.3; 3.8 | — |
| SECONDARY Secondary Endpoint Includes Total Opioid Consumption at 72 Hours |
26; 48; 40 | — |
| SECONDARY Average Nausea Scores Over 72 Hours |
0.14; 0.14; 0.06 | — |
| SECONDARY Average Sedation Scores Over 72 Hours |
0.08; 0.03; 0 | — |
| SECONDARY Subjects Overall Satisfaction Scores at Hour 24 |
3.5; 4; 3 | — |
| SECONDARY Subjects Overall Satisfaction Scores at Hour 48 |
3; 4; 4 | — |
| SECONDARY Secondary Endpoint Includes Total Opioid Consumption at 48 Hours |
48; 34; 60 | — |
| SECONDARY Secondary Endpoint Includes Total Opioid Consumption at 24 Hours |
38; 40; 36 | — |
| SECONDARY Secondary Endpoint Includes Total Opioid Consumption at 1 Hour |
16; 12; 8 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03859635). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.