Erector Spinae Plane Block vs Erector Spinae Plane Block With Serratus Anterior Plane Block in Thoracic Surgery

NCT04349774 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: STUDY19090184
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study will prospectively compare continuous Erector Spinae Plane block (ESP) versus combination of continuous Erector Spinae Plane block and single shot Serratus Anterior Plane block for post-operative pain management in subjects undergoing primary thoracic surgery.

Conditions

Pain, Postoperative

Keywords

Erector Spinae Plane block; Serratus Anterior Plane block; Thoracic Surgery; Post-operative pain

Outcome Measures

Primary Outcomes (1)

• Total narcotic medication consumption 24 hours after surgery

  Total narcotic medication consumption - reported as total Morphine equivalent 24 hours after surgery

  24 hours after surgery

Secondary Outcomes (5)

• Pain score after surgery

  6,12, and 24 hours after surgery

• Total dose of local anesthetic medication administered after surgery

  12 and 24 hours after surgery

• Percent change from baseline using incentive spirometer after nerve block administration

  6,12,and 24 hours after nerve block administration

• Total length of hospital stay

  up to one month

• Incidence of adverse effects

  up to one month

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Continuous Erector Spinae Plane block with 20ml 0.375% Bupivacaine and continuous infusion of 0.25% Lidocaine @ 12ml/hr, with single shot Serratus Anterior Plane block with 20ml 0.375% Bupivacaine

Drug: Control Group - ESP block with SAP block

Treatment Group

ACTIVE COMPARATOR

Continuous Erector Spinae Plane block with 20ml 0.375% Bupivacaine and continuous infusion of 0.25% Lidocaine @ 12ml/hr, with single shot Serratus Anterior Plane block with 20ml Normal Saline.

Drug: Treatment Group - ESP block with SAP normal saline

Interventions

Control Group - ESP block with SAP block DRUG

None - Control Group

Also known as: ESP block with SAP block

Control Group

Treatment Group - ESP block with SAP normal saline DRUG

Substitution of normal saline in place of 0.375% Bupivacaine in SAP block

Also known as: ESP block with SAP normal saline

Treatment Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18-80 years old
• Primary Unilateral Thoracic Surgery
• BMI 20 - 36, weight \> or = to 50kg
• Male and Female
• All races

You may not qualify if:

• Patient refusal
• Inpatient status at time of surgery
• ASA class \> or = 4
• Bilateral thoracic surgery
• Pregnancy
• Non-English speaking or inability to participate in the study
• Patients with coagulopathy or on therapeutic anticoagulation
• Chronic Steroid Use
• Narcotic Addiction
• Patients with contraindication to performing either block - active infection at block site, systemic infection, allergy to local anesthetic medications
• Patients undergoing second surgery or urgent/emergent surgery
• Patients weighing \<50kg

Sponsors & Collaborators

• Anna Uskova: lead

Study Sites (1)

University of Pittsburgh Medical Center (UPMC) Shadyside Hospital

Pittsburgh, Pennsylvania, 15232, United States

Location

Related Publications (40)

• Adhikary SD, Pruett A, Forero M, Thiruvenkatarajan V. Erector spinae plane block as an alternative to epidural analgesia for post-operative analgesia following video-assisted thoracoscopic surgery: A case study and a literature review on the spread of local anaesthetic in the erector spinae plane. Indian J Anaesth. 2018 Jan;62(1):75-78. doi: 10.4103/ija.IJA_693_17.

  PMID: 29416155 BACKGROUND

• Baidya DK, Khanna P, Maitra S. Analgesic efficacy and safety of thoracic paravertebral and epidural analgesia for thoracic surgery: a systematic review and meta-analysis. Interact Cardiovasc Thorac Surg. 2014 May;18(5):626-35. doi: 10.1093/icvts/ivt551. Epub 2014 Jan 31.

  PMID: 24488821 BACKGROUND

• Bang S, Chung K, Chung J, Yoo S, Baek S, Lee SM. The erector spinae plane block for effective analgesia after lung lobectomy: Three cases report. Medicine (Baltimore). 2019 Jul;98(29):e16262. doi: 10.1097/MD.0000000000016262.

  PMID: 31335674 BACKGROUND

• Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.

  PMID: 23923989 BACKGROUND

• Chin KJ. Thoracic wall blocks: From paravertebral to retrolaminar to serratus to erector spinae and back again - A review of evidence. Best Pract Res Clin Anaesthesiol. 2019 Mar;33(1):67-77. doi: 10.1016/j.bpa.2019.02.003. Epub 2019 Apr 5.

  PMID: 31272655 BACKGROUND

• Chin KJ, Malhas L, Perlas A. The Erector Spinae Plane Block Provides Visceral Abdominal Analgesia in Bariatric Surgery: A Report of 3 Cases. Reg Anesth Pain Med. 2017 May/Jun;42(3):372-376. doi: 10.1097/AAP.0000000000000581.

  PMID: 28272292 BACKGROUND

• Chu GM, Jarvis GC. Serratus Anterior Plane Block to Address Postthoracotomy and Chest Tube-Related Pain: A Report on 3 Cases. A A Case Rep. 2017 Jun 15;8(12):322-325. doi: 10.1213/XAA.0000000000000502.

  PMID: 28614112 BACKGROUND

• Cook TM, Riley RH. Analgesia following thoracotomy: a survey of Australian practice. Anaesth Intensive Care. 1997 Oct;25(5):520-4.

  PMID: 9352765 BACKGROUND

• Davies RG, Myles PS, Graham JM. A comparison of the analgesic efficacy and side-effects of paravertebral vs epidural blockade for thoracotomy--a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2006 Apr;96(4):418-26. doi: 10.1093/bja/ael020. Epub 2006 Feb 13.

  PMID: 16476698 BACKGROUND

• Fang B, Wang Z, Huang X. Ultrasound-guided preoperative single-dose erector spinae plane block provides comparable analgesia to thoracic paravertebral block following thoracotomy: a single center randomized controlled double-blind study. Ann Transl Med. 2019 Apr;7(8):174. doi: 10.21037/atm.2019.03.53.

  PMID: 31168455 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. Continuous Erector Spinae Plane Block for Rescue Analgesia in Thoracotomy After Epidural Failure: A Case Report. A A Case Rep. 2017 May 15;8(10):254-256. doi: 10.1213/XAA.0000000000000478.

  PMID: 28252539 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

• Gaio-Lima C, Costa CC, Moreira JB, Lemos TS, Trindade HL. Continuous erector spinae plane block for analgesia in pediatric thoracic surgery: A case report. Rev Esp Anestesiol Reanim (Engl Ed). 2018 May;65(5):287-290. doi: 10.1016/j.redar.2017.11.010. Epub 2018 Jan 19. English, Spanish.

  PMID: 29370900 BACKGROUND

• Gerner P. Postthoracotomy pain management problems. Anesthesiol Clin. 2008 Jun;26(2):355-67, vii. doi: 10.1016/j.anclin.2008.01.007.

  PMID: 18456219 BACKGROUND

• Kelava M, Anthony D, Elsharkawy H. Continuous Erector Spinae Block for Postoperative Analgesia After Thoracotomy in a Lung Transplant Recipient. J Cardiothorac Vasc Anesth. 2018 Oct;32(5):e9-e11. doi: 10.1053/j.jvca.2018.04.041. Epub 2018 Apr 26. No abstract available.

  PMID: 29801724 BACKGROUND

• Khalil AE, Abdallah NM, Bashandy GM, Kaddah TA. Ultrasound-Guided Serratus Anterior Plane Block Versus Thoracic Epidural Analgesia for Thoracotomy Pain. J Cardiothorac Vasc Anesth. 2017 Feb;31(1):152-158. doi: 10.1053/j.jvca.2016.08.023. Epub 2016 Aug 21.

  PMID: 27939192 BACKGROUND

• Kim DH, Oh YJ, Lee JG, Ha D, Chang YJ, Kwak HJ. Efficacy of Ultrasound-Guided Serratus Plane Block on Postoperative Quality of Recovery and Analgesia After Video-Assisted Thoracic Surgery: A Randomized, Triple-Blind, Placebo-Controlled Study. Anesth Analg. 2018 Apr;126(4):1353-1361. doi: 10.1213/ANE.0000000000002779.

  PMID: 29324496 BACKGROUND

• Kotemane NC, Gopinath N, Vaja R. Analgesic techniques following thoracic surgery: a survey of United Kingdom practice. Eur J Anaesthesiol. 2010 Oct;27(10):897-9. doi: 10.1097/EJA.0b013e32833d1259.

  PMID: 20657297 BACKGROUND

• Mayes J, Davison E, Panahi P, Patten D, Eljelani F, Womack J, Varma M. An anatomical evaluation of the serratus anterior plane block. Anaesthesia. 2016 Sep;71(9):1064-9. doi: 10.1111/anae.13549. Epub 2016 Jul 20.

  PMID: 27440171 BACKGROUND

• Munoz F, Cubillos J, Bonilla AJ, Chin KJ. Erector spinae plane block for postoperative analgesia in pediatric oncological thoracic surgery. Can J Anaesth. 2017 Aug;64(8):880-882. doi: 10.1007/s12630-017-0894-0. Epub 2017 Apr 26. No abstract available.

  PMID: 28447318 BACKGROUND

• Nath S, Bhoi D, Mohan VK, Talawar P. USG-guided continuous erector spinae block as a primary mode of perioperative analgesia in open posterolateral thoracotomy: A report of two cases. Saudi J Anaesth. 2018 Jul-Sep;12(3):471-474. doi: 10.4103/sja.SJA_755_17.

  PMID: 30100851 BACKGROUND

• Okmen K, Okmen BM. The efficacy of serratus anterior plane block in analgesia for thoracotomy: a retrospective study. J Anesth. 2017 Aug;31(4):579-585. doi: 10.1007/s00540-017-2364-9. Epub 2017 Apr 26.

  PMID: 28447227 BACKGROUND

• Park MH, Kim JA, Ahn HJ, Yang MK, Son HJ, Seong BG. A randomised trial of serratus anterior plane block for analgesia after thoracoscopic surgery. Anaesthesia. 2018 Oct;73(10):1260-1264. doi: 10.1111/anae.14424. Epub 2018 Aug 18.

  PMID: 30120832 BACKGROUND

• Piccioni F, Segat M, Falini S, Umari M, Putina O, Cavaliere L, Ragazzi R, Massullo D, Taurchini M, Del Naja C, Droghetti A. Enhanced recovery pathways in thoracic surgery from Italian VATS Group: perioperative analgesia protocols. J Thorac Dis. 2018 Mar;10(Suppl 4):S555-S563. doi: 10.21037/jtd.2017.12.86.

  PMID: 29629202 BACKGROUND

• Powell ES, Cook D, Pearce AC, Davies P, Bowler GM, Naidu B, Gao F; UKPOS Investigators. A prospective, multicentre, observational cohort study of analgesia and outcome after pneumonectomy. Br J Anaesth. 2011 Mar;106(3):364-70. doi: 10.1093/bja/aeq379. Epub 2011 Feb 2.

  PMID: 21289374 BACKGROUND

• Restrepo-Garces CE, Chin KJ, Suarez P, Diaz A. Bilateral Continuous Erector Spinae Plane Block Contributes to Effective Postoperative Analgesia After Major Open Abdominal Surgery: A Case Report. A A Case Rep. 2017 Dec 1;9(11):319-321. doi: 10.1213/XAA.0000000000000605.

  PMID: 28727597 BACKGROUND

• Saad FS, El Baradie SY, Abdel Aliem MAW, Ali MM, Kotb TAM. Ultrasound-guided serratus anterior plane block versus thoracic paravertebral block for perioperative analgesia in thoracotomy. Saudi J Anaesth. 2018 Oct-Dec;12(4):565-570. doi: 10.4103/sja.SJA_153_18.

  PMID: 30429738 BACKGROUND

• Shanthanna H, Moisuik P, O'Hare T, Srinathan S, Finley C, Paul J, Slinger P. Survey of Postoperative Regional Analgesia for Thoracoscopic Surgeries in Canada. J Cardiothorac Vasc Anesth. 2018 Aug;32(4):1750-1755. doi: 10.1053/j.jvca.2018.01.003. Epub 2018 Jan 5.

  PMID: 29402627 BACKGROUND

• Short HL, Kamalanathan K. Has analgesia changed for lung resection surgery? Anaesthesia. 2018 Apr;73(4):412-416. doi: 10.1111/anae.14188. Epub 2018 Jan 12. No abstract available.

  PMID: 29327465 BACKGROUND

• Sihoe AD, Au SS, Cheung ML, Chow IK, Chu KM, Law CY, Wan M, Yim AP. Incidence of chest wall paresthesia after video-assisted thoracic surgery for primary spontaneous pneumothorax. Eur J Cardiothorac Surg. 2004 Jun;25(6):1054-8. doi: 10.1016/j.ejcts.2004.02.018.

  PMID: 15145009 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

• Steinthorsdottir KJ, Wildgaard L, Hansen HJ, Petersen RH, Wildgaard K. Regional analgesia for video-assisted thoracic surgery: a systematic review. Eur J Cardiothorac Surg. 2014 Jun;45(6):959-66. doi: 10.1093/ejcts/ezt525. Epub 2013 Nov 27.

  PMID: 24288340 BACKGROUND

• Tamura M, Shimizu Y, Hashizume Y. Pain following thoracoscopic surgery: retrospective analysis between single-incision and three-port video-assisted thoracoscopic surgery. J Cardiothorac Surg. 2013 Jun 12;8:153. doi: 10.1186/1749-8090-8-153.

  PMID: 23759173 BACKGROUND

• Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.

  PMID: 30292068 BACKGROUND

• Tulgar S, Senturk O. Ultrasound guided low thoracic erector spinae plane block for postoperative analgesia in radical retropubic prostatectomy, a new indication. J Clin Anesth. 2018 Jun;47:4. doi: 10.1016/j.jclinane.2018.02.013. Epub 2018 Mar 5. No abstract available.

  PMID: 29518667 BACKGROUND

• Wang HJ, Liu Y, Ge WW, Bian LD, Pu LF, Jiang Y, Zhu GF, Jin XW, Li J. [Comparison of ultrasound-guided serratus anterior plane block and erector spinae plane blockperioperatively in radical mastectomy]. Zhonghua Yi Xue Za Zhi. 2019 Jun 18;99(23):1809-1813. doi: 10.3760/cma.j.issn.0376-2491.2019.23.012. Chinese.

  PMID: 31207693 BACKGROUND

• Wang L, Wang Y, Zhang X, Zhu X, Wang G. Serratus anterior plane block or thoracic paravertebral block for postoperative pain treatment after uniportal video-assisted thoracoscopic surgery: a retrospective propensity-matched study. J Pain Res. 2019 Jul 23;12:2231-2238. doi: 10.2147/JPR.S209012. eCollection 2019.

  PMID: 31413621 BACKGROUND

• Yeung JH, Gates S, Naidu BV, Wilson MJ, Gao Smith F. Paravertebral block versus thoracic epidural for patients undergoing thoracotomy. Cochrane Database Syst Rev. 2016 Feb 21;2(2):CD009121. doi: 10.1002/14651858.CD009121.pub2.

  PMID: 26897642 BACKGROUND

• Haefeli M, Elfering A. Pain assessment. Eur Spine J. 2006 Jan;15 Suppl 1(Suppl 1):S17-24. doi: 10.1007/s00586-005-1044-x. Epub 2005 Dec 1.

  PMID: 16320034 BACKGROUND

Related Links

• Clincalc.com opioid equivalent calculator

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Dmitriy Gromov, DO

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

• Anna Uskova, MD

  University of Pittsburgh Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: April 16, 2020
• Study Start: October 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: December 30, 2023
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)