Clinical trial NCT04642625: Comparison of Ultrasound-guided Bilateral ESP Block and Wound Infiltration for Spinal Surgical Analgesia
Official title: Comparison of Ultrasound-guided Bilateral Erector Spinae Plane Block and Wound Infiltration for Spinal Surgical Analgesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Spinal Disease
Anesthesia, Local
Anesthesia, Regional
Keywords: ultrasound-guided bilateral erector spina plane block
wound infiltration analgesia
spinal surgery
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2020-11-24
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in ASA I-II-III risk group aged 18-80 who will undergo spinal surgery by Trakya University Faculty of Medicine, Brain and Nerve Surgery will be included. 75 patients meeting these conditions will be included in the study.

Brief summary: The aim of our study is to determine the superior procedure in analgesia management by comparing the traditional wound infiltration technique with the ultrasound-guided bilateral erector spina plan block technique in spinal surgery patients.

Detailed description: Patients in ASA I-II-III risk group aged 18-80 who will undergo spinal surgery by Trakya University Faculty of Medicine, Brain and Nerve Surgery will be included. In this study, patient data will be collected in the form of file scanning. Intra-operative; hemodynamic data of patients; heart rate, blood pressure values, anesthetic and other drugs applied, surgery and anesthesia durations will be written from the anesthesia document after the operation is over. In the study, the application preferred by the anesthesiologist for the patient will not be intervened. The patients will be divided into three groups; wound infiltration technique was applied, ultrasound-guided bilateral erector spina plan block technique was applied and both techniques were applied together. After the operation; pain values will be calculated by VAS at the 1st, 2nd, 4th, 6th, 12th and 24th hours of the patients. The patient's length of stay, satisfaction (excellent, good, moderate, poor) and methods used for analgesia will be recorded. With the results collected in our study, it will be determined which procedure is superior in pain management for spine surgery.

Eligibility criteria: Inclusion Criteria:

* Undergoing elective spine surgery
* No contraindication to the technique to be applied
* Not pregnant
* Being over the age of 18

Exclusion Criteria:

* Undergoing emergency spine surgery
* There is an obstacle to the technical process to be applied
* Pregnant patients
* Patients younger than 18 years old

Primary outcomes:
measure: Visual Analog Score
timeFrame: postoperative 24 hours score change
Secondary outcomes:
measure: patient satisfaction
timeFrame: postoperative 24 hours score change
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Trakya University
state: Centrum
Study officials:
affiliation: Trakya University
name: SEVTAP HEKİMOĞLU ŞAHİN, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Trakya University
name: ONUR KÜÇÜK, Resident
role: PRINCIPAL_INVESTIGATOR
References: