Does ESPB Improve Postoperative Quality of Recovery After VATS

Does Ultrasound-guided Erector Spinae Plane Block Improve Postoperative Quality of Recovery After Video-assisted Thoracic Surgery

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Ropivacaine Injection; Drug: Normal saline

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.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Yusheng Yao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ESPB group; Patient will receive a single shot of Ropivacaine injection 0.5% 25 mL injected at the erector spinae plane.	Drug: Ropivacaine Injection; Ropivacaine will be injected in the erector spinae plane; Other Names: ESPB group
PLACEBO_COMPARATOR: Control Group; Patient will receive a single shot of normal saline 25 mL injected at the erector spinae plane.	Drug: Normal saline; Normal saline will be injected in the erector spinae plane.; Other Names: Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the 40-item Quality of Recovery (QoR-40) score	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).	The QoR-40 questionnaire was completed by patients at 24 hours after surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain: numeric rating scale	0-10 numeric rating scale for pain (0 minimal pain and 10 worst pain ever)	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.
cumulative opioid consumption	We recorded opioid(sufentanil) consumption at 48 hours after surgery. consumption at 6, 24, and 48 hours after surgery.cumulative opioid (sufentanil) consumption	Up to 48 hours after surgery.
PACU discharge time	Post-anesthetic recovery length of stay in minutes	Up to 2 hours
Incidence of nausea and vomiting	Patient reported sensation of nausea and incidence of vomiting related to opioid intake.	Up to 48 hours
Incidence of dizziness	Patient reported incidence of dizziness related to opioid intake.	Up to 48 hours
patient's satisfaction: numeric rating scale	Patient's satisfaction was evaluated with a 10-point numerical rating scale ranging from 1 (highly unsatisfactory) to 10 (highly satisfactory).	Patient's satisfaction was evaluated at 48 hours postoperatively.

Collaborators and Investigators

• Sponsor: Fujian Provincial Hospital
• Investigators: Study Director: Xiaochun Zheng, MD, Fujian Provincial Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 28, 2018
• Primary Completion (ACTUAL): November 12, 2019
• Study Completion (ACTUAL): November 14, 2019

Study Registration Dates

• First Submitted: November 13, 2018
• First Submitted That Met QC Criteria: November 27, 2018
• First Posted (ACTUAL): November 28, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 28, 2020
• Last Update Submitted That Met QC Criteria: January 26, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: quality of recovery; ultrasound-guided; erector spinae plane block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: K2018-10-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: It is not yet known if there will be a plan to make individual participant data (IPD) available.
• IPD Sharing Time Frame: Beginning 3 months and ending 3 years following article publication.
• IPD Sharing Access Criteria: All of the individual participant data collected during the trial, the study protocol, statistical analysis plan, and clinical study report can be accessed with approval from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No