Erector Spinae Block Versus Surgeon Infiltration in VATS Procedures

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03859635
• Other study ID #: 1809656804
• Status: Completed
• Phase: Phase 3
• Start date: February 7, 2019
• Est. completion date: November 7, 2022

Study information

• Verified date: August 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

A total of 120 subjects will be randomized by a computer program into three groups (40 per group): The primary investigator will inform the anesthesiologist who will be doing the block as to what group the patients are randomized to. The research staff completing the patients assessments will be blinded to the randomization. For the LB group (Ultrasound guided LB Erector Spinae Plane Block), patients should receive a total of 10ml 0.25% bupivacaine plus 20ml Exparel® (15ml at T4 and 15ml at T8) For the SB group (Ultrasound guided SB Erector Spinae Plane Block), patients should receive a total of 30ml 0.5% bupivacaine. (15ml at T4 and 15ml at T8) For the SI group (under video guidance) injected by surgeon using 10ml 0.25% bupivacaine plus 20ml Exparel All the erector spinae plane blocks will be placed preoperatively after sedation, before intubation and prior to surgery. 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. For the ESP block, an ultrasound probe is used to visualize the ES musculature about 3 cm laterally from the spinous process. In a cephalad-to-caudad direction advance the needle and inject the anesthetic in the interfacial plane deep to the ES muscles. Confirm positioning by visualization of needle tip and elevation of ES muscles off the transverse process with anesthetic injection. Injection will be performed at T4 and T8 level. Surgeon infiltration is performed intraoperatively under direct thoracoscopic guidance. The intercostal space will be visualized and injected with LB. Typically, T4 through T8 are infiltrated with the anesthetic mixture. All patients will be placed on ERAS protocol, which is our standard of practice. Opioid usage after the block will be recorded by a member of the research team. Pain scores at rest and on movement (knee flexion) will be measured by the investigator using Visual Analog Scale (VAS). Nausea will be measured using a categorical scoring system (none=0; mild=1; moderate=2; severe=3). Sedation scores will also be assessed by a member of the study team using a sedation scale (awake and alert=0; quietly awake=1; asleep but easily roused=2; deep sleep=3). All these parameters will be measured at 1, 24, 48 and 72 hours after the surgery. All patients will receive a phone call 6 months after surgery for assessment for chronic post-surgical pain. Patients will be assessed by a member of the research team over the phone. They will be assessed on their pain score and narcotic usage by using the Brief Pain Inventory. Study participation will conclude after the 6 month follow questionnaire has been completed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: November 7, 2022
• Est. primary completion date: November 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Pain, Postoperative
• Thoracic

Intervention

Drug:
• Liposomal Bupivacaine
20 ml
• Bupivacaine, 0.25%
10 ml
• Bupivacaine, 0.5%
30 ml

Locations

Country	Name	City	State
United States	Indiana University Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Primary endpoint of this study will be VAS pain score at 24 hours	The VAS score will be taken with both rest and movement (knee flexion) and will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain	Pain scores will be measured 24 hours after surgery
Primary	The Primary endpoint of this study will be VAS pain score at.48 hours	The VAS score will be taken with both rest and movement (knee flexion) and will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain	Pain scores will be measured 48 hours after surgery
Secondary	Secondary endpoint includes total opioid consumption at 72 hours	Opioid consumption will be collected by a study team member post operatively up to 3 days per protocol time requirements	Opioid consumption will be measured at 1 hour post op, 24,48, and 72 hours post op. The total amount will be recorded.]
Secondary	Average Nausea scores over 72 hours	Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe	Nausea scores will be documented at 1 hour post op, 24,48,and 72 hours after the block. The scores will then be averaged
Secondary	Average Sedation scores over 72 hours	Sedation scores will be documented by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is awake and alert, quietly awake, asleep and arousable, or deep sleep.	Sedation scores will be documented at 1 hour post op, 24,48,and 72 hours after the block. The scores will then be averaged.]
Secondary	Subjects overall satisfaction scores at hour 24	Subjects will be followed up at 24 hours post operatively by a study team member to document patient overall satisfaction scores	post operatively at hour 24
Secondary	Subjects overall satisfaction scores at hour 48	Subjects will be followed up at 48 hours post operatively by a study team	post operatively at hour 48