Erector Spinae Plane Block For Analgesia Following Video-Assisted Thoracoscopic Surgery

Study Overview
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Brief Summary
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Erector spinae (ESP) block is a recently described plane block designed to block the dorsal and ventral rami of the thoracic spinal nerves. It is meant to block the ipsilateral trunk. The aim of the study is to demonstrate the efficacy of the ESP block as postoperative analgesia for VATS surgery.

Detailed Description
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A growing number of thoracic surgeries are performed with a minimally invasive approach called video-assisted thoracoscopic surgery (VATS). VATS has reduced the incision size, the postoperative pain and the morbidity associated with thoracic surgery. Optimal postoperative analgesia for VATS surgery remains an open issue because although it is a lot less painful than a thoracotomy, VATS is a painful procedure with the associated risk of developing chronic pain. Adequate relief leads to early mobilization, potentially improves respiratory functions, and decreases the global stress response secondary to the surgery. Invasive analgesic techniques such as epidural or paravertebral block for VATS surgery are frequently being replaced for less invasive plane blocks to provide postoperative analgesia. At our center, anesthesiologists tend to perform epidurals only when there is a significant risk of transitioning to an open thoracotomy. Patient controlled analgesia (PCA), remains the usual analgesic technique for VATS surgery at our institution. Erector spinae (ESP) block is a recently described plane block designed to block the dorsal and ventral rami of the thoracic spinal nerves. It is meant to block the ipsilateral trunk. The aim of the study is to demonstrate the efficacy of the ESP block as postoperative analgesia for VATS surgery.

Official Title
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Erector Spinae Plane Block For Analgesia Following Video-Assisted Thoracoscopic Surgery : A Multi-Center Randomized Controlled Trial

Conditions
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Thoracic Surgery, Video-Assisted

Intervention / Treatment
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* Procedure: ESP with Bupivacaine 0.5%
* Procedure: ESP with Saline 0.9%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Patients > 18 years old with to ASA status I-III, undergoing VATS for lobectomy or wedge. Non-inclusion Criteria: < 18 years old BMI > 35 Chronic pain history with regular opioid and/or gabapentinoids use during the 2 weeks before surgery Regular marijuana use History of thoracic surgery on the operated side Epidural analgesia preferred due to an anticipated high risk of conversion to thoracotomy Unable to communicate with the investigators Receiving anticoagulation or experiencing any bleeding disorder Surgery for empyema and sympathectomy Known allergy to local anesthetics, fentanyl or hydromorphone Active infection at injection sites Preexisting neurological deficit or psychiatric illness Severe cardiovascular disease Liver failure Renal failure (estimated glomerular filtration rate <15 mL/ min/1.73 m2) Pregnancy Exclusion Criteria: Perioperative conversion to thoracotomy Severe intra- or postoperative bleeding Patients requiring postoperative mechanical ventilation Technical inability to proceed with the blocks

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Control group : Postoperative patient-controlled analgesia (PCA) pumps with Hydromorphone + Sham Erector Spinae Plane Block Intervention group : Postoperative patient-controlled analgesia (PCA) pumps with Hydromorphone + Erector Spinae Plane Block
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ESP with Bupivacaine 0.5%<br>The Erector Spinae Block (ESP) will be performed using the method described by Forero et al and Hamilton et al. in 2017 by an expert regional anesthesiologist. Thirty milliliters of bupivacaine at a concentration of 0.5% with epinephrine 1:200 000 will be injected depending on the patient's allocation. Patient controlled analgesia (PCA) settings for both groups will remain the same: hydromorphone with a bolus of 0,2 mg, lockout time of 5 minutes and no background infusion. The PCA will be started when the patient is transferred to the postanesthesia care unit (PACU). | Procedure: ESP with Bupivacaine 0.5%<br>* Regional anesthesia procedure with Bupivacaïne 0.5%<br>|
| Sham Comparator: ESP with Saline 0.9%<br>The Erector Spinae Block (ESP) will be performed using the method described by Forero et al and Hamilton et al. in 2017 by an expert regional anesthesiologist. Thirty milliliters of a placebo solution (normal saline) will be injected depending on the patient's allocation. Patient controlled analgesia (PCA) settings for both groups will remain the same: hydromorphone with a bolus of 0,2 mg, lockout time of 5 minutes and no background infusion. The PCA will be started when the patient is transferred to the postanesthesia care unit (PACU). | Procedure: ESP with Saline 0.9%<br>* Regional anesthesia procedure with Normal Saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative hydromorphone consumption | Using the Patient-Controlled Analgesia pumps, we will be able to calculate the amount of Hydromorphone that will be consumed by patients in each of our intervention arms. | 24 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thorax visual analog pain scores (VAS) : scale 0 (no pain) to 10 (worst) | Using a regular 1 to 10 visual analog chart, post-surgery. | 1-6-12-18-24 hours. | 
| Total opioid consumption post-surgery | Using the Patient-Controlled Analgesia pumps, we will be able to calculate the amount of Hydromorphone that will be consumed by patients in each of our intervention arms. | 1-6-12-18-24 hours. | 
| PONV Score : 1 to 3 (1- No nausea, 2- Nausea, 3- Vomiting) | PONV Score (3 points). | 1-6-12-18-24 hours. | 
| Ramsay Sedation Scale (RSS) 1 to 6 (1- Awake and Agitated, 2- Awake but calm to 6- Asleep and no response to loud auditory stimulus) | Sedation score of patients : Ramsay Sedation Scale (6 points). Awake ; agitated or restless or both. Awake ; cooperative, oriented, and tranquil. Awake but responds to commands only. Asleep ; brisk response to light glabellar tap or loud auditory stimulus. Asleep ; sluggish response to light glabellar tap or loud auditory stimulus. Asleep ; no response to glabellar tap or loud auditory stimulus. | 1-6-12-18-24 hours. | 
| Global QoR-15 score : 0 to 150 (worst to best) | QoR-15 Score is a score concerning the Quality of Recuperation post-surgery containing 15 questions with scales 0 to 10 (worst to best). The same questions are also asked before the surgery to understand the impact of the surgery and anesthesia. | Pre and postoperatively | 
| Amount of intraoperative Fentanyl use | Amount in micrograms | Intraoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-operative analgesia, VATS, Thoracoscopic surgery, Erector spinae plane block, Regional anesthesia