Clinical trial NCT04548076: Thoracolumbar Interfascial Plane Block in Vertebral Surgery
Official title: Investigation of Analgesic Efficacy of Thoracolumbar Interfascial Plane Block in Vertebral Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Block
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Vertebral surgery patients who will be operated under general anesthesia.

Brief summary: To determine the postoperative analgesic efficiency of thoracolumbar interfascial plane block , patients are divided into two groups. Study group received ultrasound-guided thoracolumbar interfascial plane block , where control had none. Visual analog scale and opioid consumption are recorded.

Detailed description: Thoracolumbar interfascial plane block has successfully been demonstrated to provide an efficient analgesia in patients. The present study is aimed to investigate the intraoperative hemodynamic responses, anesthetic and analgesic consumption, and postoperative recovery quality of thoracolumbar interfascial plane block in patients with vertebral surgery. After approval, patients enrolled in the study are divided into two groups by computer-based randomization technique as control and study group. After standard monitorization, anesthesia induction and tracheal intubation, erector spinae plane block is performed to study group and no intervention to control group.

In the intraoperative period, 10 mg / kg paracetamol and 0.05 mg / kg morphine will be used for postoperative analgesia. After surgery, all patients will be given 10 mg/kg paracetamol every 8 hours and will be fitted with a patient-controlled analgesia (PCA) device (Tramadol HCL). PCA device bolus dose will be set to 20 mg, lock time will be set to 10 minutes and the number of buttons per hour will be set as 3.for postoperative analgesia.After surgery, VAS scores of the patients will be evaluated (in the recovery room, 1,3,6,12 and 24 hours, Patients with VAS\>4 will be given 0.03mg / kg morphine as salvage analgesia.After 30 minutes, the patients' VAS will be re-evaluated,If VAS\>4 the same dose will be repeated. A patient satisfaction questionnaire (Qr40)will be filled by patients at the postoperative 24th hour.

Eligibility criteria: Inclusion Criteria:

Over 18 years of age, Planned to vertebral surgery, An American Society of Anesthesiologists score of 1,2 or 3

Exclusion Criteria:

Severe cardiovascular disease, Psychiatric diseases, Rejected to participation, Those who have chronic pain

Primary outcomes:
measure: Visual analog scale
timeFrame: one time in postoperative period for one year
Secondary outcomes:
measure: Opioid consumption
timeFrame: During postoperative period for one yea
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Gaziosmanpasa University
Study officials:
affiliation: Gaziosmanpasa University
name: Hakan Tapar
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tapar H, Demir O, Genc A, Balta MG, Kolukcu V, Karaman T, Dogru S, Karaman S, Suren M. Investigation of the analgesic efficacy of ultrasound-guided thoracolumbar interfacial plane block in vertebral surgery: A prospective randomized clinical study. Saudi Med J. 2022 Oct;43(10):1136-1141. doi: 10.15537/smj.2022.43.10.20220467.