Does ESPB Improve Postoperative Quality of Recovery After VATS

NCT ID: NCT03756987

Last Updated: 2020-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-28
• Study Completion Date: 2019-11-14

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ESPB group

Patient will receive a single shot of Ropivacaine injection 0.5% 25 mL injected at the erector spinae plane.

Group Type: EXPERIMENTAL

Ropivacaine Injection

Intervention Type: DRUG

Ropivacaine will be injected in the erector spinae plane

Control Group

Patient will receive a single shot of normal saline 25 mL injected at the erector spinae plane.

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

Normal saline will be injected in the erector spinae plane.

Interventions

Ropivacaine Injection

Ropivacaine will be injected in the erector spinae plane

Intervention Type: DRUG

Normal saline

Normal saline will be injected in the erector spinae plane.

Intervention Type: DRUG

Other Intervention Names

ESPB group; Control group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Provincial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yao Yusheng

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaochun Zheng, MD

Role: STUDY_DIRECTOR

Fujian Provincial Hospital

Locations

Yusheng Yao

Fuzhou, Fujian, China

Countries

China

Other Identifiers

K2018-10-001

Identifier Type: -

Identifier Source: org_study_id