Ultrasound Guided Erector Spinae Plane Block in Patients Undergoing VATS Lobectomy

NCT03176667 | Completed

• 1 other identifier: 3012
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare ESP block plus patient-controlled analgesia (PCA) to intercostal nerve block plus PCA as post-operative pain control for patients having video-assisted thorascopic surgeries.

Conditions

Post-operative Pain

Keywords

regional, erector spinae block, lobectomy, video-assisted

Outcome Measures

Primary Outcomes (2)

• Feasibility comparing two regional techniques in VATS surgery which is defined as the number of patients recruited per week.

  Number of patients recruited per week

  One week

• Number of adverse events (AEs) which can be attributed to the ESP block which is defines as the number of AEs occuring per week.

  Number of adverse events

  One week

Secondary Outcomes (2)

• Pain scores at rest and on movement

  Two days post-operatively

• Dermatome distribution to test loss of sensation to pinpricks

  Two days post-operatively

Study Arms (2)

ESP for VATS

EXPERIMENTAL

Erector Spinae plane (ESP) block

Procedure: Ultrasound guided erector spinae plane block

ICB for VATS

ACTIVE COMPARATOR

Intercostal block (ICB)

Procedure: Intercostal block

Interventions

Ultrasound guided erector spinae plane block PROCEDURE

A high-frequency linear ultrasound transducer will be placed in a longitudinal parasagittal orientation 3 cm lateral to the T5 spinous process. The trapezius, rhomboid major, and erector spinae muscles will then be identified superficial to the tip of the T5 transverse process. The patient's skin will be anesthetized with 2% lidocaine. A 17-gauge 8-cm needle will be inserted using an in-plane superior-to-inferior approach to place the tip into the fascial plane on the deep (anterior) aspect of erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process. A total of 30 mL of 0.5% ropivacaine with 5mcg/mL of epinephrine will be injected in 5-mL aliquots through the needle (maximum of 3mg/kg), followed by insertion of a 19-gauge catheter under direct vision 5 cm beyond the needle tip. The catheter will then be secured in place.

ESP for VATS

Intercostal block PROCEDURE

The surgeons will identify the desired rib, and advance the needle at an approximately 20-degree angle until contact with rib is made, the needle is then walked of the inferior border of the rib and advanced slightly to plaice the tip of the needle in the neurovascular bundle. The intercostal nerve blocks will be performed at T4-T11 using 0.25% Marcaine with epinephrine and a volume of 5 ml per block (maximum of 2.5mg/kg) after negative aspiration has been confirmed.

ICB for VATS

Eligibility Criteria

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

You may qualify if:

• Elective video-assisted thoracoscopic surgeries (VATS) lobectomies
• Elective video-assisted thoracoscopic surgeries (VATS) wedge resections

You may not qualify if:

• Patient refusal
• Contraindications to regional anesthesia
• Known allergy to local anesthetics
• Bleeding diathesis
• Use of any anti-coagulants
• Inability to provide informed consent
• Severe kidney or liver disease
• Inability to operate PCA system

Sponsors & Collaborators

• McMaster University: lead
• St. Joseph's Healthcare Hamilton: collaborator

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Related Publications (5)

• Joshi GP, Bonnet F, Shah R, Wilkinson RC, Camu F, Fischer B, Neugebauer EA, Rawal N, Schug SA, Simanski C, Kehlet H. A systematic review of randomized trials evaluating regional techniques for postthoracotomy analgesia. Anesth Analg. 2008 Sep;107(3):1026-40. doi: 10.1213/01.ane.0000333274.63501.ff.

  PMID: 18713924 BACKGROUND

• Demmy TL, Curtis JJ. Minimally invasive lobectomy directed toward frail and high-risk patients: a case-control study. Ann Thorac Surg. 1999 Jul;68(1):194-200. doi: 10.1016/s0003-4975(99)00467-1.

  PMID: 10421140 BACKGROUND

• Kim JA, Kim TH, Yang M, Gwak MS, Kim GS, Kim MJ, Cho HS, Sim WS. Is intravenous patient controlled analgesia enough for pain control in patients who underwent thoracoscopy? J Korean Med Sci. 2009 Oct;24(5):930-5. doi: 10.3346/jkms.2009.24.5.930. Epub 2009 Sep 23.

  PMID: 19794994 BACKGROUND

• Wildgaard K, Petersen RH, Hansen HJ, Moller-Sorensen H, Ringsted TK, Kehlet H. Multimodal analgesic treatment in video-assisted thoracic surgery lobectomy using an intraoperative intercostal catheter. Eur J Cardiothorac Surg. 2012 May;41(5):1072-7. doi: 10.1093/ejcts/ezr151. Epub 2011 Dec 21.

  PMID: 22219442 BACKGROUND

• Horth D, Sanh W, Moisiuk P, O'Hare T, Shargall Y, Finley C, Hanna W, Agzarian J, Forero M, Davis K, Vanniyasingam T, Thabane L, Shanthanna H. Continuous erector spinae plane block versus intercostal nerve block in patients undergoing video-assisted thoracoscopic surgery: a pilot randomized controlled trial. Pilot Feasibility Stud. 2021 Feb 24;7(1):56. doi: 10.1186/s40814-021-00801-7.

  PMID: 33627193 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: June 5, 2017
• Study Start: December 6, 2018
• Primary Completion: March 30, 2019
• Study Completion: April 15, 2019
• Last Updated: September 10, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)