Clinical trial NCT03756987: Does ESPB Improve Postoperative Quality of Recovery After VATS
Official title: Does Ultrasound-guided Erector Spinae Plane Block Improve Postoperative Quality of Recovery After Video-assisted Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: ultrasound-guided
erector spinae plane block
quality of recovery
Lead sponsor: Fujian Provincial Hospital
Sponsor class: OTHER
First posted: 2018-11-28
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Video-Assisted Thoracoscopic Surgery (VATS) is a minimally invasive surgery. Despite reduced surgical trauma compared to the traditional thoracotomy approach, pain control after VATS remains challenging. Regional analgesia may be a crucial component of multimodal postoperative pain management. The use of nerve blocks, such as the recently described erector spinae plane block (ESPB) has been shown in case reports to reduce pain and thus has the potential to improve patient recovery. This study aims to test the hypothesis that ultrasound-guided SPB would improve the quality of recovery after VATS by reducing acute postsurgical pain.

Detailed description: VATS is a minimally invasive surgical technique to remove intrathoracic lesions. VATS has become increasingly popular and gradually becoming the standard of care for lung surgery. Although acute pain after VATS is less than the traditional thoracotomy, patients still experience moderate amount of pain within the first 24 hours. However, the optimal regional analgesic technique for VATS procedures has not been established.

Thoracic epidural analgesia (TEA) and paravertebral block (PVB) have been tried to improve postoperative analgesia after VATS. Although TEA and PVB provides superior analgesia, these technologies accompanied by the rare but serious complications involving epidural hematoma, pneumothorax and total spinal anesthesia.

Erector spinae plane block (ESPB) is a novel and simple ultrasound-guided regional anesthetic technique, providing analgesia for the ipsilateral hemithorax. Ultrasound guidance is believed to improve peripheral and regional nerve block success rates and safety. ESPB is a technically easy to perform. ESPB has only been reported in case series but so far, no adverse events such as hypotension, hematoma or infection has been reported.

Given its safety, ease of performance and efficacy, the study aims to verify the hypothesis that combines ESPB with general anesthesia would accelerate functional recovery after breast cancer surgery. Our secondary aims were to examine ESPB's effect on analgesic outcomes (e.g., postoperative pain intensity, cumulative opioid consumption, postoperative nausea and vomiting, dizziness, the postanesthesia care unit discharge time and patients' satisfaction) in patients undergoing VATS.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists' physical status class of I or II
* scheduled for elective VATS

Exclusion Criteria:

* a history of allergy to local anesthetics
* known coagulation disorders
* infection near the puncture site
* chronic opioid use
* inability to communicate,
* other reasons that not appropriate for this study.

Primary outcomes:
measure: the 40-item Quality of Recovery (QoR-40) score
timeFrame: The QoR-40 questionnaire was completed by patients at 24 hours after surgery.
Secondary outcomes:
measure: postoperative pain: numeric rating scale
timeFrame: Acute postoperative pain was assessed using an numeric rating scale (NRS) at 0.5, 1, 2, 4, 8, 12, 24, and 48 hours following video-assisted thoracic surgery.
measure: cumulative opioid consumption
timeFrame: Up to 48 hours after surgery.
measure: PACU discharge time
timeFrame: Up to 2 hours
measure: Incidence of nausea and vomiting
timeFrame: Up to 48 hours
measure: Incidence of dizziness
timeFrame: Up to 48 hours
measure: patient's satisfaction: numeric rating scale
timeFrame: Patient's satisfaction was evaluated at 48 hours postoperatively.
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Yusheng Yao
state: Fujian
Study officials:
affiliation: Fujian Provincial Hospital
name: Xiaochun Zheng, MD
role: STUDY_DIRECTOR
References: