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Does ESPB Improve Postoperative Quality of Recovery After VATS

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ropivacaine Injection
Normal saline
Sponsored by
Fujian Provincial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring ultrasound-guided, erector spinae plane block, quality of recovery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Yusheng Yao

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ESPB group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

postoperative pain: numeric rating scale
0-10 numeric rating scale for pain (0 minimal pain and 10 worst pain ever)
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
PACU discharge time
Post-anesthetic recovery length of stay in minutes
Incidence of nausea and vomiting
Patient reported sensation of nausea and incidence of vomiting related to opioid intake.
Incidence of dizziness
Patient reported incidence of dizziness related to opioid intake.
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).

Full Information

First Posted
November 13, 2018
Last Updated
January 26, 2020
Sponsor
Fujian Provincial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03756987
Brief Title
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
December 28, 2018 (Actual)
Primary Completion Date
November 12, 2019 (Actual)
Study Completion Date
November 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fujian Provincial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
ultrasound-guided, erector spinae plane block, quality of recovery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The randomization sequence will be computer generated. Allocation concealment will be carried out via concealed assignments in opaque, sealed, and consecutively numbered envelopes.
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ESPB group
Arm Type
Experimental
Arm Description
Patient will receive a single shot of Ropivacaine injection 0.5% 25 mL injected at the erector spinae plane.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Patient will receive a single shot of normal saline 25 mL injected at the erector spinae plane.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine Injection
Other Intervention Name(s)
ESPB group
Intervention Description
Ropivacaine will be injected in the erector spinae plane
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
Control group
Intervention Description
Normal saline will be injected in the erector spinae plane.
Primary Outcome Measure Information:
Title
the 40-item Quality of Recovery (QoR-40) score
Description
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).
Time Frame
The QoR-40 questionnaire was completed by patients at 24 hours after surgery.
Secondary Outcome Measure Information:
Title
postoperative pain: numeric rating scale
Description
0-10 numeric rating scale for pain (0 minimal pain and 10 worst pain ever)
Time Frame
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.
Title
cumulative opioid consumption
Description
We recorded opioid(sufentanil) consumption at 48 hours after surgery. consumption at 6, 24, and 48 hours after surgery.cumulative opioid (sufentanil) consumption
Time Frame
Up to 48 hours after surgery.
Title
PACU discharge time
Description
Post-anesthetic recovery length of stay in minutes
Time Frame
Up to 2 hours
Title
Incidence of nausea and vomiting
Description
Patient reported sensation of nausea and incidence of vomiting related to opioid intake.
Time Frame
Up to 48 hours
Title
Incidence of dizziness
Description
Patient reported incidence of dizziness related to opioid intake.
Time Frame
Up to 48 hours
Title
patient's satisfaction: numeric rating scale
Description
Patient's satisfaction was evaluated with a 10-point numerical rating scale ranging from 1 (highly unsatisfactory) to 10 (highly satisfactory).
Time Frame
Patient's satisfaction was evaluated at 48 hours postoperatively.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaochun Zheng, MD
Organizational Affiliation
Fujian Provincial Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Yusheng Yao
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Does ESPB Improve Postoperative Quality of Recovery After VATS

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