NCT04990713 QoR40 Between Intercostal Block and Intercostal Block and Serratus Plane Catheter During VATS
| NCT ID | NCT04990713 |
| Status | Recruiting |
| Phase | — |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's |
| Condition | Video Assisted Thoracic Surgery (VATS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2022-06-30 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2022-06-30 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Abhijit Biswas, MD
PRINCIPAL INVESTIGATOR
Western University, Canada
Frequently Asked Questions
Who can join the NCT04990713 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Video Assisted Thoracic Surgery (VATS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04990713 currently recruiting?
Yes, NCT04990713 is actively recruiting participants. Contact the research team at abhijit.biswas@lhsc.on.ca for enrollment information.
Where is the NCT04990713 trial being conducted?
This trial is being conducted at London, Canada.
Who is sponsoring the NCT04990713 clinical trial?
NCT04990713 is sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. The principal investigator is Abhijit Biswas, MD at Western University, Canada. The trial plans to enroll 200 participants.