Effect of Bupivacaine in Ultrasound-guided Erector Spinae Plane

NCT ID: NCT03650335

Last Updated: 2019-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-15

Study Completion Date

2019-12-20

Brief Summary

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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

Detailed Description

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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

Conditions

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Thoracotomy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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group I

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

No interventions assigned to this group

group II

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yuzuncu Yıl University

OTHER

Sponsor Role lead

Responsible Party

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Celaleddin Soyalp

Assist .Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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celaleddin soyalp

Role: STUDY_CHAIR

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

Locations

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Celaleddin Soyalp

Van, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Celaleddin Soyalp

Role: CONTACT

+905068456504

Nureddin Yuzkat

Role: CONTACT

+905052294728

Facility Contacts

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Celaleddin soyalp

Role: primary

+905068456504

Nureddin Yuzkat

Role: backup

+905052294728

Other Identifiers

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ESP

Identifier Type: -

Identifier Source: org_study_id

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