Erector Spinae Plane Block For Analgesia Following Video-Assisted Thoracoscopic Surgery

Thoracic Surgery, Video-Assisted Clinical Trial

Official title:

Erector Spinae Plane Block For Analgesia Following Video-Assisted Thoracoscopic Surgery : A Multi-Center Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03860480
• Other study ID #: MP-12-2019-1640
• Status: Completed
• Phase: N/A
• Start date: November 29, 2018
• Est. completion date: December 16, 2021

Study information

• Verified date: February 2024
• Source: Ciusss de L'Est de l'Île de Montréal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Erector spinae (ESP) block is a recently described plane block designed to block the dorsal and ventral rami of the thoracic spinal nerves. It is meant to block the ipsilateral trunk. The aim of the study is to demonstrate the efficacy of the ESP block as postoperative analgesia for VATS surgery.

Description:

A growing number of thoracic surgeries are performed with a minimally invasive approach called video-assisted thoracoscopic surgery (VATS). VATS has reduced the incision size, the postoperative pain and the morbidity associated with thoracic surgery. Optimal postoperative analgesia for VATS surgery remains an open issue because although it is a lot less painful than a thoracotomy, VATS is a painful procedure with the associated risk of developing chronic pain. Adequate relief leads to early mobilization, potentially improves respiratory functions, and decreases the global stress response secondary to the surgery. Invasive analgesic techniques such as epidural or paravertebral block for VATS surgery are frequently being replaced for less invasive plane blocks to provide postoperative analgesia. At our center, anesthesiologists tend to perform epidurals only when there is a significant risk of transitioning to an open thoracotomy. Patient controlled analgesia (PCA), remains the usual analgesic technique for VATS surgery at our institution. Erector spinae (ESP) block is a recently described plane block designed to block the dorsal and ventral rami of the thoracic spinal nerves. It is meant to block the ipsilateral trunk. The aim of the study is to demonstrate the efficacy of the ESP block as postoperative analgesia for VATS surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 16, 2021
• Est. primary completion date: December 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients > 18 years old with to ASA status I-III, undergoing VATS for lobectomy or wedge.

Non-inclusion Criteria:

• < 18 years old
• BMI > 35
• Chronic pain history with regular opioid and/or gabapentinoids use during the 2 weeks before surgery
• Regular marijuana use
• History of thoracic surgery on the operated side
• Epidural analgesia preferred due to an anticipated high risk of conversion to thoracotomy
• Unable to communicate with the investigators
• Receiving anticoagulation or experiencing any bleeding disorder
• Surgery for empyema and sympathectomy
• Known allergy to local anesthetics, fentanyl or hydromorphone
• Active infection at injection sites
• Preexisting neurological deficit or psychiatric illness
• Severe cardiovascular disease
• Liver failure
• Renal failure (estimated glomerular filtration rate <15 mL/ min/1.73 m2)
• Pregnancy

Exclusion Criteria:

• Perioperative conversion to thoracotomy
• Severe intra- or postoperative bleeding
• Patients requiring postoperative mechanical ventilation
• Technical inability to proceed with the blocks

Related Conditions & MeSH terms

• Thoracic Surgery, Video-Assisted

Intervention

Procedure:
• ESP with Bupivacaine 0.5%
Regional anesthesia procedure with Bupivacaïne 0.5%
• ESP with Saline 0.9%
Regional anesthesia procedure with Normal Saline

Locations

Country	Name	City	State
Canada	Maisonneuve-Rosemont Hospital	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Ciusss de L'Est de l'Île de Montréal

Country where clinical trial is conducted

Canada, 

References & Publications (16)

Alzahrani T. Pain relief following thoracic surgical procedures: A literature review of the uncommon techniques. Saudi J Anaesth. 2017 Jul-Sep;11(3):327-331. doi: 10.4103/sja.SJA_39_17. — View Citation

Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia. 2017 Apr;72(4):452-460. doi: 10.1111/anae.13814. Epub 2017 Feb 11. — 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

Hamilton DL, Manickam B. Erector spinae plane block for pain relief in rib fractures. Br J Anaesth. 2017 Mar 1;118(3):474-475. doi: 10.1093/bja/aex013. No abstract available. — 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

Kartalov A, Jankulovski N, Kuzmanovska B, Zdravkovska M, Shosholcheva M, Spirovska T, Petrusheva AP, Tolevska M, Srceva M, Durnev V, Jota G, Selmani R, Sivevski A. Effect of Adding Dexamethasone as a Ropivacaine Adjuvant in Ultrasound-Guided Transversus Abdominis Plane Block for Inguinal Hernia Repair. Pril (Makedon Akad Nauk Umet Odd Med Nauki). 2015;36(3):35-41. doi: 10.1515/prilozi-2015-0076. — View Citation

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. — View Citation

Khoshbin E, Al-Jilaihawi AN, Scott NB, Prakash D, Kirk AJ. An audit of pain control pathways following video-assisted thoracoscopic surgery. Innovations (Phila). 2011 Jul;6(4):248-52. doi: 10.1097/IMI.0b013e31822b2cc1. — View Citation

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. — View Citation

Kosinski S, Fryzlewicz E, Wilkojc M, Cmiel A, Zielinski M. Comparison of continuous epidural block and continuous paravertebral block in postoperative analgaesia after video-assisted thoracoscopic surgery lobectomy: a randomised, non-inferiority trial. Anaesthesiol Intensive Ther. 2016;48(5):280-287. doi: 10.5603/AIT.2016.0059. — View Citation

Lonnqvist PA, MacKenzie J, Soni AK, Conacher ID. Paravertebral blockade. Failure rate and complications. Anaesthesia. 1995 Sep;50(9):813-5. doi: 10.1111/j.1365-2044.1995.tb06148.x. — View Citation

Okmen K, Metin Okmen B. Evaluation of the effect of serratus anterior plane block for pain treatment after video-assisted thoracoscopic surgery. Anaesth Crit Care Pain Med. 2018 Aug;37(4):349-353. doi: 10.1016/j.accpm.2017.09.005. Epub 2017 Oct 12. — View Citation

Scimia P, Basso Ricci E, Droghetti A, Fusco P. The Ultrasound-Guided Continuous Erector Spinae Plane Block for Postoperative Analgesia in Video-Assisted Thoracoscopic Lobectomy. Reg Anesth Pain Med. 2017 Jul/Aug;42(4):537. doi: 10.1097/AAP.0000000000000616. No abstract available. — View Citation

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. — 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

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative hydromorphone consumption	Using the Patient-Controlled Analgesia pumps, we will be able to calculate the amount of Hydromorphone that will be consumed by patients in each of our intervention arms.	24 hours.
Secondary	Thorax visual analog pain scores (VAS) : scale 0 (no pain) to 10 (worst)	Using a regular 1 to 10 visual analog chart, post-surgery.	1-6-12-18-24 hours.
Secondary	Total opioid consumption post-surgery	Using the Patient-Controlled Analgesia pumps, we will be able to calculate the amount of Hydromorphone that will be consumed by patients in each of our intervention arms.	1-6-12-18-24 hours.
Secondary	PONV Score : 1 to 3 (1- No nausea, 2- Nausea, 3- Vomiting)	PONV Score (3 points).	1-6-12-18-24 hours.
Secondary	Ramsay Sedation Scale (RSS) 1 to 6 (1- Awake and Agitated, 2- Awake but calm to 6- Asleep and no response to loud auditory stimulus)	Sedation score of patients : Ramsay Sedation Scale (6 points).; Awake ; agitated or restless or both.; Awake ; cooperative, oriented, and tranquil.; Awake but responds to commands only.; Asleep ; brisk response to light glabellar tap or loud auditory stimulus.; Asleep ; sluggish response to light glabellar tap or loud auditory stimulus.; Asleep ; no response to glabellar tap or loud auditory stimulus.	1-6-12-18-24 hours.
Secondary	Global QoR-15 score : 0 to 150 (worst to best)	QoR-15 Score is a score concerning the Quality of Recuperation post-surgery containing 15 questions with scales 0 to 10 (worst to best). The same questions are also asked before the surgery to understand the impact of the surgery and anesthesia.	Pre and postoperatively
Secondary	Amount of intraoperative Fentanyl use	Amount in micrograms	Intraoperatively