NCT05242328

Brief Summary

Ultrasound-guided erector spinae plane block (ESPB) is an interfascial blockade during thoracic anesthesia, first described by Forero in 2016, and is highlighted by technically feasibility and less complication rate. The patient is placed as decubitus position. The anesthesiologists use echo to identify the ipsilateral transverse process at T5 level, and insert the needle to 2-3 cm lateral to the spinous process until contact the transverse process. Then the injected local anesthetic will penetrate via erector spinae muscle to paravertebral space to affect and relieve pain.

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 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

Study Start

First participant enrolled

January 5, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 16, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2024

Completed
Last Updated

February 27, 2023

Status Verified

December 1, 2022

Enrollment Period

4 years

First QC Date

January 26, 2022

Last Update Submit

February 23, 2023

Conditions

Post-operative Pain, AcutePost-operative PainThoracic DiseasesPost-Op Complication

Keywords

Uniportal video-assisted thoracoscopic surgeryUltrasound-guided erector spinae plane blocksurgical thoracoscopic intercostal nerve blockcumulative intravenous morphine consumptionvisual analogue scaleEnhanced Recovery After Surgery

Outcome Measures

Primary Outcomes (2)

  • Visual analogue scale

    post-op VAS score, 0-10, the higher means painful, and "0" point no pain.

    post-op 2 days

  • accumulated morphine usage dose

    accumulated morphine usage dose

    post-op 2 days

Study Arms (2)

post-operative VAS score of Ultrasound-guided erector spinae plane block

ACTIVE COMPARATOR
Procedure: Ultrasound-guided erector spinae plane block

post-operative VAS score of surgical thoracoscopic intercostal nerve block

ACTIVE COMPARATOR
Procedure: surgical thoracoscopic intercostal nerve block

Interventions

Ultrasound-guided erector spinae plane blockPROCEDURE

Ultrasound-guided erector spinae plane block

post-operative VAS score of Ultrasound-guided erector spinae plane block
surgical thoracoscopic intercostal nerve blockPROCEDURE

surgical thoracoscopic intercostal nerve block

post-operative VAS score of surgical thoracoscopic intercostal nerve block

Eligibility Criteria

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

You may qualify if:

  • adult patients, over 20 years old, u
  • undergoing elective uniportal VATS lobectomy.

You may not qualify if:

  • patient refusal,
  • body mass index \> 35 kg/m2,
  • American society of anesthesiologists (ASA) grade above 3,
  • contraindication to nerve block,
  • allergy to analgesic agents,
  • regular opioid used for chronic pain prior to this time surgery,
  • conversion to thoracotomy or VATS procedure,
  • postoperative intubation,
  • postoperative intensive care unit admission.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng Kung University Hospital

Tainan, Taiwan

RECRUITING

MeSH Terms

Conditions

Pain, PostoperativeThoracic DiseasesPostoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsRespiratory Tract Diseases

Study Officials

  • Shuoying Dai

    National Cheng-Kung University Hospital

    STUDY CHAIR

Central Study Contacts

Shuoying Dai, MD

CONTACT

+886-6-2353535hsnu_10@yahoo.com.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2022

First Posted

February 16, 2022

Study Start

January 5, 2021

Primary Completion

December 26, 2024

Study Completion

December 26, 2024

Last Updated

February 27, 2023

Record last verified: 2022-12

Locations

TW(1)