Erector Spinae Block Versus Surgeon Infiltration in VATS Procedures

NCT03859635 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 1809656804
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Thoracic; Acute Pain

Keywords

acute pain; VATS

Outcome Measures

Primary Outcomes (4)

• The Primary Endpoint of This Study Will be 24 Hours VAS 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

  24 hours pain score at rest

• The Primary Endpoint of This Study Will be 24 Hours VAS 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

  24 hours pain score with movement

• The Primary Endpoint of This Study Will be 48 Hours VAS 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

  48 hours pain score at rest

• The Primary Endpoint of This Study Will be 48 Hours VAS 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

  48 hours pain score with movement

Secondary Outcomes (8)

• 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.]

• 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

• 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.]

• Subjects Overall Satisfaction Scores at Hour 24

  post operatively at hour 24

• Subjects Overall Satisfaction Scores at Hour 48

  post operatively at hour 48

Study Arms (3)

Ultrasound guided Liposomal Bupivacaine Erector Spinae Block

ACTIVE COMPARATOR

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.

Drug: Liposomal Bupivacaine; Drug: Bupivacaine, 0.25%

Ultrasound guided Standard Bupivacaine Erector Spinae Block

ACTIVE COMPARATOR

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.

Drug: Bupivacaine, 0.5%

Surgeon Infiltration

ACTIVE COMPARATOR

At the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8.

Drug: Liposomal Bupivacaine; Drug: Bupivacaine, 0.25%

Interventions

Liposomal Bupivacaine DRUG

20 ml

Surgeon Infiltration; Ultrasound guided Liposomal Bupivacaine Erector Spinae Block

Bupivacaine, 0.25% DRUG

10 ml

Surgeon Infiltration; Ultrasound guided Liposomal Bupivacaine Erector Spinae Block

Bupivacaine, 0.5% DRUG

30 ml

Ultrasound guided Standard Bupivacaine Erector Spinae Block

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (15)

• Bottiger BA, Esper SA, Stafford-Smith M. Pain management strategies for thoracotomy and thoracic pain syndromes. Semin Cardiothorac Vasc Anesth. 2014 Mar;18(1):45-56. doi: 10.1177/1089253213514484. Epub 2013 Dec 12.

  PMID: 24336691 BACKGROUND

• Singh S, Chowdhary NK. Erector spinae plane block an effective block for post-operative analgesia in modified radical mastectomy. Indian J Anaesth. 2018 Feb;62(2):148-150. doi: 10.4103/ija.IJA_726_17. No abstract available.

  PMID: 29491525 BACKGROUND

• Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15.

  PMID: 29913392 BACKGROUND

• Rao Kadam V, Currie J. Ultrasound-guided continuous erector spinae plane block for postoperative analgesia in video-assisted thoracotomy. Anaesth Intensive Care. 2018 Mar;46(2):243-245. No abstract available.

  PMID: 29519230 BACKGROUND

• Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

  PMID: 27501016 BACKGROUND

• Forero M, Rajarathinam M, Adhikary S, Chin KJ. Erector spinae plane (ESP) block in the management of post thoracotomy pain syndrome: A case series. Scand J Pain. 2017 Oct;17:325-329. doi: 10.1016/j.sjpain.2017.08.013. Epub 2017 Sep 12.

  PMID: 28919152 BACKGROUND

• Taylor R, Massey S, Stuart-Smith K. Postoperative analgesia in video-assisted thoracoscopy: the role of intercostal blockade. J Cardiothorac Vasc Anesth. 2004 Jun;18(3):317-21. doi: 10.1053/j.jvca.2004.03.012.

  PMID: 15232812 BACKGROUND

• Wu ZQ, Min JK, Wang D, Yuan YJ, Li H. Liposome bupivacaine for pain control after total knee arthroplasty: a meta-analysis. J Orthop Surg Res. 2016 Jul 22;11(1):84. doi: 10.1186/s13018-016-0420-z.

  PMID: 27443874 BACKGROUND

• Yu ZX, Yang ZZ, Yao LL. Effectiveness of liposome bupivacaine for postoperative pain control in total knee arthroplasty: A PRISMA-compliant meta-analysis of randomized controlled trials. Medicine (Baltimore). 2018 Mar;97(13):e0171. doi: 10.1097/MD.0000000000010171.

  PMID: 29595645 BACKGROUND

• Ma TT, Wang YH, Jiang YF, Peng CB, Yan C, Liu ZG, Xu WX. Liposomal bupivacaine versus traditional bupivacaine for pain control after total hip arthroplasty: A meta-analysis. Medicine (Baltimore). 2017 Jun;96(25):e7190. doi: 10.1097/MD.0000000000007190.

  PMID: 28640101 BACKGROUND

• Raman S, Lin M, Krishnan N. Systematic review and meta-analysis of the efficacy of liposomal bupivacaine in colorectal resections. J Drug Assess. 2018 Jun 29;7(1):43-50. doi: 10.1080/21556660.2018.1487445. eCollection 2018.

  PMID: 29988796 BACKGROUND

• Knudson RA, Dunlavy PW, Franko J, Raman SR, Kraemer SR. Effectiveness of Liposomal Bupivacaine in Colorectal Surgery: A Pragmatic Nonsponsored Prospective Randomized Double Blinded Trial in a Community Hospital. Dis Colon Rectum. 2016 Sep;59(9):862-9. doi: 10.1097/DCR.0000000000000648.

  PMID: 27505115 BACKGROUND

• Knight RB, Walker PW, Keegan KA, Overholser SM, Baumgartner TS, Ebertowski JS 2nd, Aden JK, White MA. A Randomized Controlled Trial for Pain Control in Laparoscopic Urologic Surgery: 0.25% Bupivacaine Versus Long-Acting Liposomal Bupivacaine. J Endourol. 2015 Sep;29(9):1019-24. doi: 10.1089/end.2014.0769. Epub 2015 Jun 5.

  PMID: 25897552 BACKGROUND

• Noviasky J, Pierce DP, Whalen K, Guharoy R, Hildreth K. Bupivacaine liposomal versus bupivacaine: comparative review. Hosp Pharm. 2014 Jun;49(6):539-43. doi: 10.1310/hpj4906-539.

  PMID: 24958971 BACKGROUND

• Kaplowitz J, Papadakos PJ. Acute pain management for video-assisted thoracoscopic surgery: an update. J Cardiothorac Vasc Anesth. 2012 Apr;26(2):312-21. doi: 10.1053/j.jvca.2011.04.010. Epub 2011 Jun 25. No abstract available.

  PMID: 21705236 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Yar Luan Yeap, MD
• Organization: Indiana University Department of Anesthesiology

yyeap@iu.edu

3172740275

Study Officials

• Yar Yeap, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Anesthesiology. Director, Acute Pain Service

Model Details: Patients are randomized into one of three groups: 1. Ultrasound guided LB Erector Spinae Plane Block with 20ml of Exparel and 10ml 0.25% bupivacaine 2. Ultrasound guided SB Erector Spinae Plane Block with 30ml 0.5% bupivacaine 3. Surgeon Infiltration under video guidance with 20ml of Exparel and 10ml of 0.25% bupivacaine

Study Record Dates

• First Submitted: February 28, 2019
• First Posted: March 1, 2019
• Study Start: February 7, 2019
• Primary Completion: November 6, 2022
• Study Completion: November 7, 2022
• Last Updated: February 28, 2025
• Results First Posted: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)