Effect of Bupivacaine in Ultrasound-guided Erector Spinae Plane

• Conditions: Thoracotomy

• Registration Number: NCT03650335
• Lead Sponsor: Yuzuncu Yıl University

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

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 Timeline

• Status Verified: 2018-08
• Study First Submitted: 2018-08-25
• Study First Submitted QC: 2018-08-27
• Study First Posted: 2018-08-28
• Last Update Submitted: 2019-01-30
• Last Update Posted: 2019-02-01
• Study Start: 2019-02-15
• Primary Completion: 2019-11-30
• Study Completion: 2019-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
postoperative opioid consumption	First 24 hours total opioid consumption	Total opioid consumption as microgram/kg will be assessed in 24 hour surgery

Trial Locations

Locations (1)

Celaleddin Soyalp; 🇹🇷 VAN, Turkey