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Completed

NCT Number: NCT03860480

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ESP with Bupivacaine 0.5%

Procedure

Regional anesthesia procedure with Bupivacaïne 0.5%

ESP with Saline 0.9%

Procedure

Regional anesthesia procedure with Normal Saline

Primary outcomes

  1. Postoperative hydromorphone consumption

    Time frame: 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.

Secondary outcomes

  1. Thorax visual analog pain scores (VAS) : scale 0 (no pain) to 10 (worst)

    Time frame: 1-6-12-18-24 hours.

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

  2. Total opioid consumption post-surgery

    Time frame: 1-6-12-18-24 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.

  3. PONV Score : 1 to 3 (1- No nausea, 2- Nausea, 3- Vomiting)

    Time frame: 1-6-12-18-24 hours.

    PONV Score (3 points).

  4. 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)

    Time frame: 1-6-12-18-24 hours.

    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.
  5. Global QoR-15 score : 0 to 150 (worst to best)

    Time frame: 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.

  6. Amount of intraoperative Fentanyl use

    Time frame: Intraoperatively

    Amount in micrograms

Sponsors and collaborators

Lead sponsor

Ciusss de L'Est de l'Île de Montréal

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Mar 4, 2019
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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