NCT05044247

Brief Summary

Since the original publication on the erector spinae plane (ESP) block in 2016, the technique of the ESP block has evolved significantly in the last few years. Current reports suggest that the ESP block provides adequate analgesia in thoracic and abdominal sites in a post-surgical and chronic pain patient. However, there were still inconsistencies and unclear spread of local anesthetics in ultrasound guide ESP block. This study focusing on the spread of local anesthetic in ESP block under ultrasound and fluoroscopy and possible mechanisms of action.

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
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 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

April 20, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 14, 2021

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2020

Enrollment Period

4 months

First QC Date

September 5, 2021

Last Update Submit

September 22, 2021

Conditions

Pain, ChronicPain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Pain scale

    reduction of Visual Analogue Scale

    12 months

Study Arms (1)

ESP block

EXPERIMENTAL

ESP block under mixed local anesthetics, betamethasone agent

Procedure: ESP blocks

Interventions

ESP blocksPROCEDURE

ultrasound and fluoroscopy to identify the spread of drug

ESP block

Eligibility Criteria

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

You may qualify if:

  • Thirty-five patients in each group of breast tumor surgery and pain intervention procedure patients.
  • Age \> 20

You may not qualify if:

  • Unable to complete questionnaires.
  • With coagulopathy
  • History of thoracic spine trauma or surgery.
  • Allergy to contrast local anesthetics and medium (Iohexol)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Cancer Center

Taipei County, Taiwan

RECRUITING

MeSH Terms

Conditions

Chronic PainPain, Postoperative

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Central Study Contacts

Wen-Ying Lin

CONTACT

0223220322ying434@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2021

First Posted

September 14, 2021

Study Start

April 20, 2021

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

September 28, 2021

Record last verified: 2020-09

Locations

TW(1)