Clinical trial NCT03650335: Effect of Bupivacaine in Ultrasound-guided Erector Spinae Plane
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thoracotomy
Keywords: erector spine plan block
postoperative opioid consumption
thoracotomy
analgesia
anesthesia
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2018-08-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing thoracotomy

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

Eligibility criteria: 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

Primary outcomes:
measure: postoperative opioid consumption
timeFrame: First 24 hours total opioid consumption
Secondary outcomes:
Other outcomes:
Locations:
city: VAN
country: Turkey
facility: Celaleddin Soyalp
Study officials:
affiliation: Yuzuncu Yil University Dursun Odabas Medical School Anesthesiology and Reanimation Department Van, Turkey
name: celaleddin soyalp
role: STUDY_CHAIR
References: