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OpenTrials
Completed

NCT Number: NCT04548076

Thoracolumbar Interfascial Plane Block in Vertebral Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gaziosmanpasa University

Tokat Province, 60200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Block group

Other

Control group

Other names: Patients received thoracolumbar interfascial plane block before operation

Primary outcomes

  1. Visual analog scale

    Time frame: one time in postoperative period for one year

    Visual analog scale

Secondary outcomes

  1. Opioid consumption

    Time frame: During postoperative period for one yea

    Opioid consumption

Sponsors and collaborators

Lead sponsor

Tokat Gaziosmanpasa University

Other

Registry information

Official study title

Investigation of Analgesic Efficacy of Thoracolumbar Interfascial Plane Block in Vertebral Surgery

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 14, 2020
Registry last updated
Mar 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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