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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03860480
Enrollment
52
Registered
2019-03-04
Start date
2018-11-29
Completion date
2021-12-16
Last updated
2024-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thoracic Surgery, Video-Assisted

Keywords

Post-operative analgesia, VATS, Thoracoscopic surgery, Erector spinae plane block, Regional anesthesia

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.

Interventions

PROCEDUREESP with Bupivacaine 0.5%

Regional anesthesia procedure with Bupivacaïne 0.5%

PROCEDUREESP with Saline 0.9%

Regional anesthesia procedure with Normal Saline

Sponsors

Ciusss de L'Est de l'Île de Montréal
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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).
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.
Global QoR-15 score : 0 to 150 (worst to best)Pre and postoperativelyQoR-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 useIntraoperativelyAmount in micrograms
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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026