MedPath

Does ESPB Improve Postoperative Quality of Recovery After VATS

Not Applicable
Completed
Conditions
Postoperative Pain
Interventions
Drug: Normal saline
Registration Number
NCT03756987
Lead Sponsor
Fujian Provincial Hospital
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
76
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ESPB groupRopivacaine InjectionPatient will receive a single shot of Ropivacaine injection 0.5% 25 mL injected at the erector spinae plane.
Control GroupNormal salinePatient will receive a single shot of normal saline 25 mL injected at the erector spinae plane.
Primary Outcome Measures
NameTimeMethod
the 40-item Quality of Recovery (QoR-40) scoreThe QoR-40 questionnaire was completed by patients at 24 hours after surgery.

QoR-40 incorporates 40 questions assessing 5 dimensions of recovery, including emotional status, physical comfort, psychological support, physical independence, and pain. The global QoR-40 score ranges from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).

Secondary Outcome Measures
NameTimeMethod
postoperative pain: numeric rating scaleAcute 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.

0-10 numeric rating scale for pain (0 minimal pain and 10 worst pain ever)

PACU discharge timeUp to 2 hours

Post-anesthetic recovery length of stay in minutes

cumulative opioid consumptionUp to 48 hours after surgery.

We recorded opioid(sufentanil) consumption at 48 hours after surgery. consumption at 6, 24, and 48 hours after surgery.cumulative opioid (sufentanil) consumption

Incidence of nausea and vomitingUp to 48 hours

Patient reported sensation of nausea and incidence of vomiting related to opioid intake.

patient's satisfaction: numeric rating scalePatient's satisfaction was evaluated at 48 hours postoperatively.

Patient's satisfaction was evaluated with a 10-point numerical rating scale ranging from 1 (highly unsatisfactory) to 10 (highly satisfactory).

Incidence of dizzinessUp to 48 hours

Patient reported incidence of dizziness related to opioid intake.

Trial Locations

Locations (1)

Yusheng Yao

🇨🇳

Fuzhou, Fujian, China

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