NCT03831581

Brief Summary

Interventional study that evaluate dermatomal distribution and its demographic determinants in patients who underwent to Erector Spinae Plane (ESP) block

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

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

Study Start

First participant enrolled

January 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2019

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 6, 2019

Completed
Last Updated

May 24, 2023

Status Verified

November 1, 2018

Enrollment Period

10 months

First QC Date

January 14, 2019

Last Update Submit

May 23, 2023

Conditions

Keywords

Erector Spinae PlaneErector Spinae Plane Block

Outcome Measures

Primary Outcomes (1)

  • Dermatomes with sensitive block

    Number (average) of dermatomes with sensitive block with pinprick and cold achieved at 60 minutes after the Erector Spinae Plane (ESP) block with 20 ml of bupivacaine 0.5%. Also, observe the distribution pattern.

    60 minutes

Secondary Outcomes (7)

  • weight

    60 minutes

  • Adverse events

    60 minutes and 24 hours

  • Success rate

    60 minutes and 24 hours

  • Degree of satisfaction

    60 minutes and 24 hours

  • Visual Analogue Scale (VAS)

    60 minutes and 24 hours

  • +2 more secondary outcomes

Study Arms (1)

Erector Spinae Plane Block

EXPERIMENTAL

Patients with chest pain or upper abdomen underwent Erector Spinae Plane Block guided by ultrasound, bupivacaine 0.5% 20 ml was administered in the interfascial plane between the transverse process of T5 and the erector muscles of the spine, 60 minutes after dermatomes distribution was evaluated with pinprick and cold.

Procedure: Erector Spinae Plane Block

Interventions

In patients with chest pain, ultrasound-guided Erector Spinae Plane Block block was performed at T5 transverse process in the cephalo-caudal direction with Tuohy 18 gauge needle in plane until the needle tip was located in the interfascial plane between the transverse process and the erector spinae muscles, 20 ml of bupivacaine 0.5% was administered and a catheter was inserted if indicated.

Erector Spinae Plane Block

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients older than 18 years, in the acute / chronic pain service that presents pain in the thoracic region and / or upper hemiabdomen.

You may not qualify if:

  • Women in pregnancy
  • Patients with less than 50 Kg of weight
  • Dissent of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

hospital universitario San Vicente Fundacion

Medellín, Antioquia, Colombia

Location

Related Publications (1)

  • Barrios A, Camelo J, Gomez J, Forero M, Peng PWH, Visbal K, Cadavid A. Evaluation of Sensory Mapping of Erector Spinae Plane Block. Pain Physician. 2020 Jun;23(3):E289-E296.

MeSH Terms

Conditions

Chronic PainPain, Postoperative

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Officials

  • Adriana Cadavid

    Universidad de Antioquia

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

January 14, 2019

First Posted

February 6, 2019

Study Start

January 1, 2018

Primary Completion

October 31, 2018

Study Completion

October 31, 2018

Last Updated

May 24, 2023

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Only final results of research

Locations