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

NCT03860480 | Completed

• 1 other identifier: MP-12-2019-1640
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thoracic Surgery, Video-Assisted

Keywords

Post-operative analgesia; VATS; Thoracoscopic surgery; Erector spinae plane block; Regional anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Thorax visual analog pain scores (VAS) : scale 0 (no pain) to 10 (worst)

  1-6-12-18-24 hours.

• Total opioid consumption post-surgery

  1-6-12-18-24 hours.

• PONV Score : 1 to 3 (1- No nausea, 2- Nausea, 3- Vomiting)

  1-6-12-18-24 hours.

• 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)

  1-6-12-18-24 hours.

• Global QoR-15 score : 0 to 150 (worst to best)

  Pre and postoperatively

Study Arms (2)

ESP with Bupivacaine 0.5%

ACTIVE COMPARATOR

The Erector Spinae Block (ESP) will be performed using the method described by Forero et al and Hamilton et al. in 2017 by an expert regional anesthesiologist. Thirty milliliters of bupivacaine at a concentration of 0.5% with epinephrine 1:200 000 will be injected depending on the patient's allocation. Patient controlled analgesia (PCA) settings for both groups will remain the same: hydromorphone with a bolus of 0,2 mg, lockout time of 5 minutes and no background infusion. The PCA will be started when the patient is transferred to the postanesthesia care unit (PACU).

Procedure: ESP with Bupivacaine 0.5%

ESP with Saline 0.9%

SHAM COMPARATOR

The Erector Spinae Block (ESP) will be performed using the method described by Forero et al and Hamilton et al. in 2017 by an expert regional anesthesiologist. Thirty milliliters of a placebo solution (normal saline) will be injected depending on the patient's allocation. Patient controlled analgesia (PCA) settings for both groups will remain the same: hydromorphone with a bolus of 0,2 mg, lockout time of 5 minutes and no background infusion. The PCA will be started when the patient is transferred to the postanesthesia care unit (PACU).

Procedure: ESP with Saline 0.9%

Interventions

ESP with Bupivacaine 0.5% PROCEDURE

Regional anesthesia procedure with Bupivacaïne 0.5%

ESP with Bupivacaine 0.5%

ESP with Saline 0.9% PROCEDURE

Regional anesthesia procedure with Normal Saline

ESP with Saline 0.9%

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead

Study Sites (1)

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Location

Related 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.

  PMID: 28757835 BACKGROUND

• 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.

  PMID: 28188621 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

• 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.

  PMID: 28203765 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 BACKGROUND

• 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.

  PMID: 27442394 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

• 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.

  PMID: 22437983 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

• 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.

  PMID: 28000203 BACKGROUND

• 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.

  PMID: 7573876 BACKGROUND

• 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.

  PMID: 29033355 BACKGROUND

• 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.

  PMID: 28632673 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

• 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

MeSH Terms

Interventions

Parapsychology; Sodium Chloride

Intervention Hierarchy (Ancestors)

Behavioral Sciences; Behavioral Disciplines and Activities; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ariane Clairoux, MD

  Maisonneuve-Rosemont Hospital / CIUSSS de l'Est-de-l'Île-de-Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Anesthesiology and Pain Medicine

Model Details: Control group : Postoperative patient-controlled analgesia (PCA) pumps with Hydromorphone + Sham Erector Spinae Plane Block Intervention group : Postoperative patient-controlled analgesia (PCA) pumps with Hydromorphone + Erector Spinae Plane Block

Study Record Dates

• First Submitted: January 21, 2019
• First Posted: March 4, 2019
• Study Start: November 29, 2018
• Primary Completion: December 16, 2021
• Study Completion: December 16, 2021
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)