Effect of Bupivacaine in Ultrasound-guided Erector Spinae Plane

January 30, 2019 updated by: Celaleddin Soyalp, Yuzuncu Yıl University

Effect of Two Different Volumes of Bupivacaine 0.25% Used in Ultrasound-guided Erector Spinae Plane (ESP) Block on Dermatome Spread: A Volume Study

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

Study Overview

Status

Unknown

Conditions

Detailed Description

The study will have a double-blind design and will be conducted after obtaining an approval from the local ethics committee. The study will include 50 patients planned for thoracotomy, aged 18-65 years with an ASA score of I-II. The patients will be randomized by sealed tender and will be divided into 2 groups with 25 patients each. 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, and patients with an ASA score of III or IV will be excluded from the study. All the patients will undergo physical examination and their laboratory parameters will be evaluated one day prior to the procedure. Moreover, on the same day, each patient will be informed about dermatome testing (hot/cold), pain prick test (pain test), and pain pump set. Age, body height and weight, duration of block, and duration of surgery will be recorded for each patient

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • VAN, Turkey, 65080
        • Recruiting
        • Celaleddin Soyalp
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing thoracotomy

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative opioid consumption
Time Frame: First 24 hours total opioid consumption
Total opioid consumption as microgram/kg will be assessed in 24 hour surgery
First 24 hours total opioid consumption

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuzuncu Yıl University

Investigators

  • Study Chair: celaleddin soyalp, Yuzuncu Yil University Dursun Odabas Medical School Anesthesiology and Reanimation Department Van, Turkey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 15, 2019

Primary Completion (Anticipated)

November 30, 2019

Study Completion (Anticipated)

December 20, 2019

Study Registration Dates

First Submitted

August 25, 2018

First Submitted That Met QC Criteria

August 27, 2018

First Posted (Actual)

August 28, 2018

Study Record Updates

Last Update Posted (Actual)

February 1, 2019

Last Update Submitted That Met QC Criteria

January 30, 2019

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ESP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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