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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04548076
Other study ID # 20-KAEK-076
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 7, 2020
Est. completion date November 7, 2021

Study information

Verified date March 2022
Source Tokat Gaziosmanpasa University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date November 7, 2021
Est. primary completion date August 21, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Block group
Control group

Locations

Country Name City State
Turkey Gaziosmanpasa University Tokat

Sponsors (1)

Lead Sponsor Collaborator
Tokat Gaziosmanpasa University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual analog scale Visual analog scale one time in postoperative period for one year
Secondary Opioid consumption Opioid consumption During postoperative period for one yea
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