QORVATS Study. A Randomized Controlled, Triple Blinded to Compare the Quality of Recovery (QoR 40) Between Intercostal Block and a Combination of Intercostal Nerve Block With Serratus Plane Catheter for Patient's Undergoing VATS Procedures.

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
London Health Sciences Centre
RECRUITING
London
Contact Information
Primary
Abhijit Biswas, MD
abhijit.biswas@lhsc.on.ca
5196858500
Time Frame
Start Date: 2022-06-30
Estimated Completion Date: 2026-01-31
Participants
Target number of participants: 200
Treatments
Placebo_comparator: Serratus Plane Block (Placebo) and Intercostal Block (Local Anesthestic)
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%.
Experimental: Serratus Plane Block (Local Anesthetic) and Intercostal Block (Local Anesthetic)
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%.
Related Therapeutic Areas
Sponsors
Leads: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

This content was sourced from clinicaltrials.gov