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Perioperative Erector Spinae Plane Block in Thoracoscopic Surgery

NCT ID: NCT03777592

Last Updated: 2019-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-15

Study Completion Date

2020-11-30

Brief Summary

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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

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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.

Conditions

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Pain, Postoperative Regional Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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ESPB with local agent

ESPB will be performed using 20ml of 0.5% ropivacaine.

Group Type ACTIVE_COMPARATOR

erector spinae plane block

Intervention Type PROCEDURE

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

ESPB with saline

ESPB will be performed using 20ml of saline.

Group Type SHAM_COMPARATOR

erector spinae plane block

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kangbuk Samsung Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sung Hyun Lee

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sung Hyun Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Kangbuk Samsung Hospital

Locations

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KangbukSamsung Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Sung Hyun Lee, MD

Role: CONTACT

Phone: 82-2-2001-2323

Email: [email protected]

Kyoung-Ho Ryu, MD

Role: CONTACT

Phone: 82-2-2001-1376

Email: [email protected]

Facility Contacts

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Sung Hyun Lee, MD

Role: primary

Other Identifiers

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2018-09-017-001

Identifier Type: -

Identifier Source: org_study_id