Clinical trial NCT03860480: Erector Spinae Plane Block For Analgesia Following Video-Assisted Thoracoscopic Surgery
Official title: Erector Spinae Plane Block For Analgesia Following Video-Assisted Thoracoscopic Surgery : A Multi-Center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracic Surgery, Video-Assisted
Keywords: Post-operative analgesia
VATS
Thoracoscopic surgery
Erector spinae plane block
Regional anesthesia
Lead sponsor: Ciusss de L'Est de l'Île de Montréal
Sponsor class: OTHER
First posted: 2019-03-04
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative hydromorphone consumption
timeFrame: 24 hours.
Secondary outcomes:
measure: Thorax visual analog pain scores (VAS) : scale 0 (no pain) to 10 (worst)
timeFrame: 1-6-12-18-24 hours.
measure: Total opioid consumption post-surgery
timeFrame: 1-6-12-18-24 hours.
measure: PONV Score : 1 to 3 (1- No nausea, 2- Nausea, 3- Vomiting)
timeFrame: 1-6-12-18-24 hours.
measure: 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)
timeFrame: 1-6-12-18-24 hours.
measure: Global QoR-15 score : 0 to 150 (worst to best)
timeFrame: Pre and postoperatively
measure: Amount of intraoperative Fentanyl use
timeFrame: Intraoperatively
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Maisonneuve-Rosemont Hospital
state: Quebec
Study officials:
affiliation: Maisonneuve-Rosemont Hospital / CIUSSS de l'Est-de-l'Île-de-Montréal
name: Ariane Clairoux, MD
role: PRINCIPAL_INVESTIGATOR
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