Effect of Bupivacaine in Ultrasound-guided Erector Spinae Plane

Thoracotomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03650335
• Other study ID #: ESP
• Status: Recruiting
• Start date: February 15, 2019
• Est. completion date: December 20, 2019

Study information

• Verified date: August 2018
• Source: Yuzuncu Yil University
• Contact: Celaleddin Soyalp
• Phone: +905068456504
• Email: c.soyalp[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 20, 2019
• Est. primary completion date: November 30, 2019
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Thoracotomy

Locations

Country	Name	City	State
Turkey	Celaleddin Soyalp	VAN

Sponsors (1)

Lead Sponsor	Collaborator
Yuzuncu Yil University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative opioid consumption	Total opioid consumption as microgram/kg will be assessed in 24 hour surgery	First 24 hours total opioid consumption