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

Not Applicable
Completed
Conditions
Thoracic Surgery, Video-Assisted
Interventions
Procedure: ESP with Bupivacaine 0.5%
Procedure: ESP with Saline 0.9%
Registration Number
NCT03860480
Lead Sponsor
Ciusss de L'Est de l'Île de Montréal
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
52
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ESP with Bupivacaine 0.5%ESP with Bupivacaine 0.5%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).
ESP with Saline 0.9%ESP with Saline 0.9%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).
Primary Outcome Measures
NameTimeMethod
Postoperative hydromorphone consumption24 hours.

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.

Secondary Outcome Measures
NameTimeMethod
Thorax visual analog pain scores (VAS) : scale 0 (no pain) to 10 (worst)1-6-12-18-24 hours.

Using a regular 1 to 10 visual analog chart, post-surgery.

Total opioid consumption post-surgery1-6-12-18-24 hours.

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.

PONV Score : 1 to 3 (1- No nausea, 2- Nausea, 3- Vomiting)1-6-12-18-24 hours.

PONV Score (3 points).

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)1-6-12-18-24 hours.

Sedation score of patients : Ramsay Sedation Scale (6 points).

1. Awake ; agitated or restless or both.

2. Awake ; cooperative, oriented, and tranquil.

3. Awake but responds to commands only.

4. Asleep ; brisk response to light glabellar tap or loud auditory stimulus.

5. Asleep ; sluggish response to light glabellar tap or loud auditory stimulus.

6. Asleep ; no response to glabellar tap or loud auditory stimulus.

Global QoR-15 score : 0 to 150 (worst to best)Pre and postoperatively

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.

Amount of intraoperative Fentanyl useIntraoperatively

Amount in micrograms

Trial Locations

Locations (1)

Maisonneuve-Rosemont Hospital

🇨🇦

Montréal, Quebec, Canada

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