NCT03777592

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

December 15, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 17, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

February 28, 2019

Status Verified

February 1, 2019

Enrollment Period

1.5 years

First QC Date

December 12, 2018

Last Update Submit

February 26, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

ESPB with local agent

ACTIVE COMPARATOR

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

Procedure: erector spinae plane block

ESPB with saline

SHAM COMPARATOR

ESPB will be performed using 20ml of saline.

Procedure: erector spinae plane block

Interventions

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 local agentESPB with saline

Eligibility Criteria

Age19 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists Patients with physical class 1, 2
  • Patients undergoing video assisted thoracoscopic surgery

You may not qualify if:

  • Patients who experienced side effects on local anesthetics
  • Patients with abnormal blood coagulation tests (INR\> 1.5)
  • Pregnant or lactating patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KangbukSamsung Hospital

Seoul, 03181, South Korea

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Sung Hyun Lee, MD

    Kangbuk Samsung Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sung Hyun Lee, MD

CONTACT

Kyoung-Ho Ryu, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 12, 2018

First Posted

December 17, 2018

Study Start

December 15, 2018

Primary Completion

June 1, 2020

Study Completion

November 1, 2020

Last Updated

February 28, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations