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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patient refusal to participate in the study.

Emergency surgery.

Allergies to local anesthetics

BMI>40

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Procedure/Surgery

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

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

    Procedure/Surgery

    Patients will receive saline placebo via serratus plane block

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Serratus Plane Block (Placebo) and Intercostal Block (Local Anesthestic)Placebo comparator 1 intervention
Group B: Serratus Plane Block (Local Anesthetic) and Intercostal Block (Local Anesthetic)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Quality of Recovery

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

Time frame
Measured on postoperative day 1

Secondary outcomes

1

Postoperative pain scores

Pain will be assessed on an 11- point numerical scale of '0' to '10'. Zero signifies no pain whereas 10 signifies maximum pain. Measured by asking patient to rate their pain using this scale. This will be measured every 24 hours following surgery until the patient is discharged, on average one week.

Time frame
Until patient discharge, on average one week.
2

Total opioid consumption

Total opioid consumption will be administered in IV morphine equivalents. This will be assessed daily upon admission to post-anesthesia care unit (postoperative care unit) until day of discharge, on average one week. Measured by evaluating patient's medical record for administered morphine equivalents.

Time frame
Until patient discharge, on average one week.
3

Postoperative complications after thoracic surgery

Any complication that requires assessment and/or treatment postoperatively. This will be recorded by evaluating the patient's medical chart for any noted complication following surgery.

Time frame
Immediately following surgery until discharge, on average one week.
4

Hospital readmission

Instances that the patient may be re-admitted to the hospital following discharge after surgery. To be measured by evaluating the patient's medical record.

Time frame
30 days postoperative

Other outcomes

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