NCT03949790

Brief Summary

A randomized prospective trial to test the effect of additional Erector Spinae Plane Block (ESPB) with intercostal nerve block during video assisted thoracoscopic 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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

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

May 6, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 14, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

June 18, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

September 24, 2019

Status Verified

September 1, 2019

Enrollment Period

12 months

First QC Date

May 6, 2019

Last Update Submit

September 20, 2019

Conditions

Video Assisted Thoracoscopic Surgery

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain

    VAS score (Visual Analog Scale for Pain, 0-10, higher value represent a worse outcome)

    1 hour after surgery

Secondary Outcomes (5)

  • Postoperative Pain

    6 hours after surgery

  • Postoperative Pain

    12 hours after surgery

  • Postoperative Pain

    24 hours after surgery

  • Postoperative Pain

    48 hours after surgery

  • Opioid consumption

    postoperative 24 hours

Study Arms (2)

Intercostal block with ESPB

ACTIVE COMPARATOR

Performed ESPB in VATs with intercostal nerve block

Procedure: ESPB and Intercostal nerve block

Intercostal block without ESPB

ACTIVE COMPARATOR

Not Performed ESPB in VATs with intercostal nerve block

Procedure: Intercostal nerve block

Interventions

ESPB and Intercostal nerve blockPROCEDURE

Erector spinae plane block + Intercostal nerve block

Intercostal block with ESPB
Intercostal nerve blockPROCEDURE

Intercostal nerve block

Intercostal block without ESPB

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Wedge Resection or Lobectomy under VATS approach.

You may not qualify if:

  • Age \< 20 years
  • Patients who has anatomical abnormality in any spine
  • Patients who has skin infection near to be the present procedure site
  • Intercostal nerve block is not performed during surgery
  • Previous lung surgery history of affected side

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SMG - SNU Boramae Medical Center

Seoul, 07061, South Korea

RECRUITING

Related Publications (5)

  • Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia. 2017 Apr;72(4):452-460. doi: 10.1111/anae.13814. Epub 2017 Feb 11.

    PMID: 28188621BACKGROUND

  • Forero M, Rajarathinam M, Adhikary S, Chin KJ. Continuous Erector Spinae Plane Block for Rescue Analgesia in Thoracotomy After Epidural Failure: A Case Report. A A Case Rep. 2017 May 15;8(10):254-256. doi: 10.1213/XAA.0000000000000478.

    PMID: 28252539BACKGROUND

  • Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

    PMID: 27501016BACKGROUND

  • Hamilton DL, Manickam B. Erector spinae plane block for pain relief in rib fractures. Br J Anaesth. 2017 Mar 1;118(3):474-475. doi: 10.1093/bja/aex013. No abstract available.

    PMID: 28203765BACKGROUND

  • Forero M, Rajarathinam M, Adhikary S, Chin KJ. Erector spinae plane (ESP) block in the management of post thoracotomy pain syndrome: A case series. Scand J Pain. 2017 Oct;17:325-329. doi: 10.1016/j.sjpain.2017.08.013. Epub 2017 Sep 12.

    PMID: 28919152BACKGROUND

Study Officials

  • Tae Kyong Kim, MD, phD

    SMG-SNU Boramae

    STUDY CHAIR

Central Study Contacts

Tae Kyong Kim, Md, phD

CONTACT

+82-2-870-2519ktkktk@gmail.com

Study Design

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

Study Record Dates

First Submitted

May 6, 2019

First Posted

May 14, 2019

Study Start

June 18, 2019

Primary Completion

June 1, 2020

Study Completion

July 1, 2020

Last Updated

September 24, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)