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

C

Ciusss de L'Est de l'Île de Montréal

Status

Completed

Conditions

Thoracic Surgery, Video-Assisted

Treatments

Procedure: ESP with Saline 0.9%
Procedure: ESP with Bupivacaine 0.5%

Study type

Interventional

Funder types

Other

Identifiers

NCT03860480
MP-12-2019-1640

Details and patient eligibility

About

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.

Full 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.

Enrollment

52 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

52 participants in 2 patient groups

ESP with Bupivacaine 0.5%
Active Comparator group
Description:
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).
Treatment:
Procedure: ESP with Bupivacaine 0.5%
ESP with Saline 0.9%
Sham Comparator group
Description:
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).
Treatment:
Procedure: ESP with Saline 0.9%

Trial contacts and locations

1

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Central trial contact

Ariane Clairoux, MD; Philippe Richebé, MD, PhD

Data sourced from clinicaltrials.gov

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