NCT03650335

Brief Summary

To investigate the effect of two different volumes of bupivacaine 0.25% used in ultrasound-guided erector spinae plane (ESP) block on dermatome spread and postoperative analgesia in patients undergoing unilateral thoracotomy

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

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

August 25, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 28, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

February 15, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
Last Updated

February 1, 2019

Status Verified

August 1, 2018

Enrollment Period

10 months

First QC Date

August 25, 2018

Last Update Submit

January 30, 2019

Conditions

Thoracotomy

Keywords

erector spine plan blockpostoperative opioid consumptionthoracotomyanalgesiaanesthesia

Outcome Measures

Primary Outcomes (1)

  • postoperative opioid consumption

    Total opioid consumption as microgram/kg will be assessed in 24 hour surgery

    First 24 hours total opioid consumption

Study Arms (2)

group I

with a total of 20 mL 0.25% bupivacaine injection to be administered

group II

with a total of 30 mL 0.25% bupivacaine injection to be administered

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing thoracotomy

You may qualify if:

  • Patients scheduled for elective thoracotomy
  • Aged 18-65 years
  • ASA score of I and II

You may not qualify if:

  • Patients that will be transferred to the intensive care unit (ICU) intubated after the surgery,
  • Patients with a body mass index of 35 or over,
  • Patients detected with infection in the intervention site,
  • Patients with hematological diseases,
  • Patients with a known allergy to local anesthetics,
  • Patients that will not provide a written or verbal consent,
  • Pregnant patients
  • Patients with an ASA score of III or IV will be excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Celaleddin Soyalp

Van, 65080, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • celaleddin soyalp

    Yuzuncu Yil University Dursun Odabas Medical School Anesthesiology and Reanimation Department Van, Turkey

    STUDY CHAIR

Central Study Contacts

Celaleddin Soyalp

CONTACT

+905068456504c.soyalp@hotmail.com

Nureddin Yuzkat

CONTACT

+905052294728nyuzkat@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist .Prof.

Study Record Dates

First Submitted

August 25, 2018

First Posted

August 28, 2018

Study Start

February 15, 2019

Primary Completion

November 30, 2019

Study Completion

December 20, 2019

Last Updated

February 1, 2019

Record last verified: 2018-08

Locations

TU(1)