Clinical trial

Randomized Prospective Study Comparing Exparel Erector Spinae Plane Block vs Simple Bupivacaine Erector Spinae Plane Block vs Exparel Surgeon Infiltration for Postoperative Analgesia Following Video-assisted Thoracoscopic Surgery

Name
1809656804
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.
Trial arms
Trial start
2019-02-07
Estimated PCD
2022-11-06
Trial end
2022-11-07
Status
Completed
Phase
Early phase I
Treatment
Liposomal Bupivacaine
20 ml
Arms:
Surgeon Infiltration, Ultrasound guided Liposomal Bupivacaine Erector Spinae Block
Bupivacaine, 0.25%
10 ml
Arms:
Surgeon Infiltration, Ultrasound guided Liposomal Bupivacaine Erector Spinae Block
Bupivacaine, 0.5%
30 ml
Arms:
Ultrasound guided Standard Bupivacaine Erector Spinae Block
Size
125
Primary endpoint
The Primary endpoint of this study will be VAS pain score at 24 hours
Pain scores will be measured 24 hours after surgery
The Primary endpoint of this study will be VAS pain score at.48 hours
Pain scores will be measured 48 hours after surgery
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients are randomized into one of three groups:\n\n1. Ultrasound guided LB Erector Spinae Plane Block with 20ml of Exparel and 10ml 0.25% bupivacaine\n2. Ultrasound guided SB Erector Spinae Plane Block with 30ml 0.5% bupivacaine\n3. Surgeon Infiltration under video guidance with 20ml of Exparel and 10ml of 0.25% bupivacaine', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 125, 'type': 'ACTUAL'}}
Updated at
2023-08-16

1 organization

2 products

3 indications

Organization
Indiana University
Indication
Pain
Indication
Postoperative
Indication
Thoracic