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
Verified date | February 2024 |
Source | Ciusss de L'Est de l'Île de Montréal |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Maisonneuve-Rosemont Hospital | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Ciusss de L'Est de l'Île de Montréal |
Canada,
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
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 |
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