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Thoracolumbar Interfascial Plane Block in Vertebral Surgery

NCT04548076 — Completed, 64 participants, Tokat Gaziosmanpasa University

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

RegistryNCT04548076
StatusCompleted
Study typeObservational
Enrollment64 (Actual)
SponsorTokat Gaziosmanpasa University (Other)
ConditionsBlock
InterventionsBlock group (Other)
Datesstart 2020-09-07, primary completion 2021-08-21, completion 2021-11-07, first posted 2020-09-14, last updated 2022-03-15
Locations1 site in Turkey (Türkiye)

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-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.

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+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.

+Arms and interventions

  • Block group (Other), also known as Patients received thoracolumbar interfascial plane block before operation: Control group

+Outcome measures

Primary outcomes

  • Visual analog scale [one time in postoperative period for one year]: Visual analog scale

Secondary outcomes

  • Opioid consumption [During postoperative period for one yea]: Opioid consumption

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Gaziosmanpasa UniversityTokat ProvinceTurkey (Türkiye)

+Publications

  • Results publication: 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. PMID 36261200

+Investigators

  • Hakan Tapar, Principal investigator, Gaziosmanpasa University

My Notes