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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03777592
Other study ID # 2018-09-017-001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 15, 2018
Est. completion date November 2020

Study information

Verified date February 2019
Source Kangbuk Samsung Hospital
Contact Sung Hyun Lee, MD
Phone 82-2-2001-2323
Email 4321hoho@naver.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 54
Est. completion date November 2020
Est. primary completion date June 2020
Accepts healthy volunteers No
Gender All
Age group 19 Years to 85 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
erector spinae plane block
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

Locations

Country Name City State
Korea, Republic of KangbukSamsung Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Kangbuk Samsung Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.)
the first 5 min after arriving at the recovery room
Primary 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.) 20 min after arriving at the recovery room
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