NCT05723393

Brief Summary

The primary endpoint of this study was to identify if erector spinae plane bloock (ESPB) demonstrates any sympatholytic effect. The secondary endpoint of this study was to compare the changes of PI value between responders and non-responders.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

February 2, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 10, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

February 13, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2023

Completed
Last Updated

July 12, 2023

Status Verified

July 1, 2023

Enrollment Period

5 months

First QC Date

February 2, 2023

Last Update Submit

July 10, 2023

Conditions

Pain, Chronic

Outcome Measures

Primary Outcomes (3)

  • Perfusion index changes among 4 times period

    Perfusion index changes after T2 ESPB among 4 times period

    baseline, 10minutes after ESPB, 20 minutes after ESPB, 30 minutes after ESPB

  • Numerical rating scale changes among 3 times period

    Numerical rating scale changes among 3 times period

    baseline, 30 minutes after ESPB, 2 weeks after ESPB

  • Perfusion index ratio at 10 minutes

    Perfusion index ratio at 10 minutes

    baseline, 10minutes after ESPB

Study Arms (1)

20 ml T2 ESPB group

EXPERIMENTAL

T2 ESPB group where ESPB is performed at T2 with local anesthetics 20ml

Procedure: Erector spinae plane block

Interventions

Erector spinae plane blockPROCEDURE

fascial plane injection guided by ultrasound

20 ml T2 ESPB group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Complex regional pain syndrome
  • Post-thoracotomy pain syndrome
  • Cervical foraminal stenosis
  • Cervical disc herniation
  • Herpes zoster

You may not qualify if:

  • Pregnacy
  • Coagulation abormality
  • Previous spine surgery
  • Allergy to local anesthetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ji Hoon Park

Daegu, 42601, South Korea

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ji H Hong

    Keimyung University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 2, 2023

First Posted

February 10, 2023

Study Start

February 13, 2023

Primary Completion

July 10, 2023

Study Completion

July 10, 2023

Last Updated

July 12, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)