Back to resultsPerioperative Erector Spinae Plane Block in Thoracoscopic Surgery
Primary Purpose
Pain, Postoperative, Regional Block
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
erector spinae plane block
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility Criteria
Inclusion Criteria:
- American Society of Anesthesiologists Patients with physical class 1, 2
- Patients undergoing video assisted thoracoscopic surgery
Exclusion Criteria:
- Patients who experienced side effects on local anesthetics
- Patients with abnormal blood coagulation tests (INR> 1.5)
- Pregnant or lactating patients
Sites / Locations
- KangbukSamsung HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
ESPB with local agent
ESPB with saline
Arm Description
ESPB will be performed using 20ml of 0.5% ropivacaine.
ESPB will be performed using 20ml of saline.
Outcomes
Primary Outcome Measures
Pain scale
11-point numeric rating scale(
(Scores from 0 to 10 are scored. The higher the score, the higher the degree of pain.The score is given in units of one point.)
Pain scale
11-point numeric rating scale (Scores from 0 to 10 are scored. The higher the score, the higher the degree of pain.The score is given in units of one point.)
Secondary Outcome Measures
Full Information
NCT ID
NCT03777592
First Posted
December 12, 2018
Last Updated
February 26, 2019
Sponsor
Kangbuk Samsung Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03777592
Brief Title
Perioperative Erector Spinae Plane Block in Thoracoscopic Surgery
Official Title
Correlation Between Perioperative Erector Spinae Plane Block and Postoperative Pain in Thoracoscopic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 15, 2018 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
November 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kangbuk Samsung Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The erector spinae plane block (ESPB) is a novel myofascial plane block. The ESPB is targeted at anterior surface of the erector spinae plane, which is oriented cephalocaudally to the spinal transverse process. Local anaesthetic injected in this plane can block the dorsal rami and ventral rami and intercostal nerves. The aim of this study was to evaluate the effect of ESPB on postoperative pain in thoracic surgery.
Detailed Description
The erector spinae plane block (ESPB) is a newly defined regional anesthesia technique for thoracic analgesia. The blocks were performed at the T5 level of the spine using an in-plane approach.Previous studies were not designed as randomized controlled trial. In this study, the efficacy of ESPB is to confirm with randomized controlled trial design. ESPB will be performed in video assisted thoracoscopy preoperatively. After the surgery, the efficacy of ESPB will be assessed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Regional Block
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ESPB with local agent
Arm Type
Active Comparator
Arm Description
ESPB will be performed using 20ml of 0.5% ropivacaine.
Arm Title
ESPB with saline
Arm Type
Sham Comparator
Arm Description
ESPB will be performed using 20ml of saline.
Intervention Type
Procedure
Intervention Name(s)
erector spinae plane block
Intervention Description
local anesthetic or saline is administered in to the interfascial plane between the transverse process of the vertebra and the erector spinae muscles, spreading to multiple paravertebral spaces
Primary Outcome Measure Information:
Title
Pain scale
Description
11-point numeric rating scale(
(Scores from 0 to 10 are scored. The higher the score, the higher the degree of pain.The score is given in units of one point.)
Time Frame
the first 5 min after arriving at the recovery room
Title
Pain scale
Description
11-point numeric rating scale (Scores from 0 to 10 are scored. The higher the score, the higher the degree of pain.The score is given in units of one point.)
Time Frame
20 min after arriving at the recovery room
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
American Society of Anesthesiologists Patients with physical class 1, 2
Patients undergoing video assisted thoracoscopic surgery
Exclusion Criteria:
Patients who experienced side effects on local anesthetics
Patients with abnormal blood coagulation tests (INR> 1.5)
Pregnant or lactating patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sung Hyun Lee, MD
Phone
82-2-2001-2323
Email
4321hoho@naver.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kyoung-Ho Ryu, MD
Phone
82-2-2001-1376
Email
drkhryu@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung Hyun Lee, MD
Organizational Affiliation
Kangbuk Samsung Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
KangbukSamsung Hospital
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung Hyun Lee, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Perioperative Erector Spinae Plane Block in Thoracoscopic Surgery
We'll reach out to this number within 24 hrs