QoR40 Between Intercostal Block and Intercostal Block and Serratus Plane Catheter During VATS

NCT04990713 | Recruiting

• 1 other identifier: QORVATS
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Video assisted thoracic surgery (VATS) has emerged as standard of care for majority of thoracic surgeries. It is less invasive compared to thoracotomy and is associated with improved perioperative outcomes \[1-3\]. Good perioperative analgesia after thoracic surgery will enable pulmonary toilet, early chest physiotherapy and mobilisation, \[4,5,6\]. Thirty-day hospital visits and hospital readmissions at London Health Sciences Centre (LHSC) is around 21% and 9% respectively \[7\]. One of the top five determinant for hospital visit and readmission in 30 days, was persistent post operative pain \[7\]. Several options to analgesia are available for patients undergoing VATS procedure. Systemic opioid based multimodal analgesia, central neuraxial blocks like thoracic epidural and peripheral nerve blocks are different available options, and their practise varies across institution \[4,8,9\]. Thoracic epidural or paravertebral blocks can be challenging to perform with high failure rates \[10-12\]. Fascial plane blocks (SAB; ESP) are in vogue in the present era \[13-16\]. They are easy to perform and do not require similar dexterity as needed to perform thoracic epidural or paravertebral blocks. They have minimal side effects and provide the options for continuous infusion for prolonged analgesia. They have become an effective part of multimodal analgesia and have established their roles in ERAS (enhanced recovery after surgery) protocol for VATS procedures. SAB has become a common practise at our institution with proved clinical efficacy. Perioperative Surgical Home is a patient centric team-based approach to improve patient's experiences in the perioperative period and thus improve healthcare \[17\]. Quality of Recovery (QoR) is a key determinant to perioperative surgical home and can be measured using the QoR 40 score \[18\]. This is a well validated score with a minimal important clinical difference (MICD) of 6.3 \[19\]. Quality of recovery combines five dimensions of health: patient support, comfort, emotions, physical independence and pain to achieve a single patient outcome - improved patient care \[18\]. The investigators hypothesize the that patients undergoing VATS lung resections using a combination of intercostal nerve block plus continuous SAB catheter infusion of local anesthetics will have a 20% increase in their QoR-40 score 24hour after the surgery compared to a single shot intercostal nerve block.

Conditions

Video Assisted Thoracic Surgery (VATS); Pain Management

Keywords

Intercostal Block; Fascial Plane Block

Outcome Measures

Primary Outcomes (1)

• Quality of Recovery

  Measured using the Quality of Recovery 40 (Qor-40) Score and asking patients to complete the questions.

  Measured on postoperative day 1

Secondary Outcomes (5)

• Postoperative pain scores

  Until patient discharge, on average one week.

• Total opioid consumption

  Until patient discharge, on average one week.

• Postoperative complications after thoracic surgery

  Immediately following surgery until discharge, on average one week.

• Hospital readmission

  30 days postoperative

• Side effects

  Until patient discharge, on average one week.

Study Arms (2)

Serratus Plane Block (Placebo) and Intercostal Block (Local Anesthestic)

PLACEBO COMPARATOR

Patients randomized to this group will receive the intercostal block with local anesthetic and the serratus plane block with saline placebo. Local anesthetic administered will be ropivacaine 0.2%.

Procedure: Serratus Plane Block (Placebo) and Intercostal Block (Local Anesthestic)

Serratus Plane Block (Local Anesthetic) and Intercostal Block (Local Anesthetic)

EXPERIMENTAL

Patients randomized to this group will receive the intercostal block with local anesthetic and the serratus plane block with local anesthetic. Local anesthetic administered will be ropivacaine 0.2%.

Procedure: Serratus Plane Block (Local Anesthetic) and Intercostal Block (Local Anesthetic)

Interventions

Serratus Plane Block (Local Anesthetic) and Intercostal Block (Local Anesthetic) PROCEDURE

Patients will receive local anesthetic via serratus plane block as opposed to saline placebo

Also known as: Serratus Plane Block administering Ropivacaine 0.2%

Serratus Plane Block (Local Anesthetic) and Intercostal Block (Local Anesthetic)

Serratus Plane Block (Placebo) and Intercostal Block (Local Anesthestic) PROCEDURE

Patients will receive saline placebo via serratus plane block

Also known as: Serratus Plane Block administering Saline Placebo

Serratus Plane Block (Placebo) and Intercostal Block (Local Anesthestic)

Eligibility Criteria

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

You may qualify if:

• Patients undergoing elective VATS lung resections including wedge resection, segmentectomy, bi-lobectomy, or lobectomy.
• Age \> 18 years.
• ASA (American Society of Anesthesiology) Score - 1 to 4.
• Gender - all genders
• Patients able to consent to participate in the study

You may not qualify if:

• Patient refusal to participate in the study.
• Emergency surgery.
• Allergies to local anesthetics
• BMI\>40
• Presence of local (chest wall) or systemic infection.
• Previous lung resection on the same hemithorax.
• Patient suffering from chronic pain defined by persistent pain more than six month.
• Conversion to thoracotomy

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Sciences Centre

London, Ontairo, N6A 5A5, Canada

RECRUITING

Related Publications (19)

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  PMID: 28329213 BACKGROUND

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  PMID: 7330380 BACKGROUND

• Cattaneo SM, Park BJ, Wilton AS, Seshan VE, Bains MS, Downey RJ, Flores RM, Rizk N, Rusch VW. Use of video-assisted thoracic surgery for lobectomy in the elderly results in fewer complications. Ann Thorac Surg. 2008 Jan;85(1):231-5; discussion 235-6. doi: 10.1016/j.athoracsur.2007.07.080.

  PMID: 18154816 BACKGROUND

• Marshall K, McLaughlin K. Pain Management in Thoracic Surgery. Thorac Surg Clin. 2020 Aug;30(3):339-346. doi: 10.1016/j.thorsurg.2020.03.001. Epub 2020 Apr 29.

  PMID: 32593366 BACKGROUND

• Heinrich S, Janitz K, Merkel S, Klein P, Schmidt J. Short- and long term effects of epidural analgesia on morbidity and mortality of esophageal cancer surgery. Langenbecks Arch Surg. 2015 Jan;400(1):19-26. doi: 10.1007/s00423-014-1248-9. Epub 2014 Sep 21.

  PMID: 25240610 BACKGROUND

• Saeki H, Ishimura H, Higashi H, Kitagawa D, Tanaka J, Maruyama R, Katoh H, Shimazoe H, Yamauchi K, Ayabe H, Kakeji Y, Morita M, Maehara Y. Postoperative management using intensive patient-controlled epidural analgesia and early rehabilitation after an esophagectomy. Surg Today. 2009;39(6):476-80. doi: 10.1007/s00595-008-3924-2. Epub 2009 May 27.

  PMID: 19468802 BACKGROUND

• LHSC, data support team financial year 2017-2018

  BACKGROUND

• Bernhard GC. Auranofin treatment for adult rheumatoid arthritis. Comparison of 2 mg and 6 mg daily dose. J Rheumatol Suppl. 1982 Jul-Aug;8:149-53.

  PMID: 6813477 BACKGROUND

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  PMID: 29169795 BACKGROUND

• Hermanides J, Hollmann MW, Stevens MF, Lirk P. Failed epidural: causes and management. Br J Anaesth. 2012 Aug;109(2):144-54. doi: 10.1093/bja/aes214. Epub 2012 Jun 26.

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  PMID: 11167441 BACKGROUND

• Naja Z, Lonnqvist PA. Somatic paravertebral nerve blockade. Incidence of failed block and complications. Anaesthesia. 2001 Dec;56(12):1184-8. doi: 10.1046/j.1365-2044.2001.02084-2.x.

  PMID: 11736777 BACKGROUND

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• Viti A, Bertoglio P, Zamperini M, Tubaro A, Menestrina N, Bonadiman S, Avesani R, Guerriero M, Terzi A. Serratus plane block for video-assisted thoracoscopic surgery major lung resection: a randomized controlled trial. Interact Cardiovasc Thorac Surg. 2020 Mar 1;30(3):366-372. doi: 10.1093/icvts/ivz289.

  PMID: 31808538 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

• 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

• Kain ZN, Vakharia S, Garson L, Engwall S, Schwarzkopf R, Gupta R, Cannesson M. The perioperative surgical home as a future perioperative practice model. Anesth Analg. 2014 May;118(5):1126-30. doi: 10.1213/ANE.0000000000000190. No abstract available.

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  PMID: 27159009 BACKGROUND

• Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.

  PMID: 10740540 BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Anesthetics, Local

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Abhijit Biswas, MD

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abhijit Biswas, MD

CONTACT

5196858500; abhijit.biswas@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participant, treating anesthesiologist and surgical team, and outcomes assessor will be blinded to prevent bias. One of the study team co-investigators who is not the treating anesthesiologist during the participants's surgery will prepare the study drugs. The treating anesthesiologist will not be aware of the contents of the study drugs.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Anesthesiologist

Model Details: There will be two study groups. All study participants will receive serratus plane block (SAB) with catheter for continuous infusion and an intercostal block. Depending on the group allocation, the study participants may receive local anesthetics or placebo for the serratus plane block.

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: August 4, 2021
• Study Start: June 30, 2022
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)