Thoracolumbar Interfascial Plane Block in Vertebral Surgery

NCT ID: NCT04548076

Last Updated: 2022-03-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 64 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-07
• Study Completion Date: 2021-11-07

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.

Conditions

Block

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Interventions

Block group

Control group

Intervention Type: OTHER

Other Intervention Names

Patients received thoracolumbar interfascial plane block before operation

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tokat Gaziosmanpasa University

OTHER

Sponsor Role: lead

Responsible Party

Hakan Tapar

Tokat Gaziosmanpasa University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hakan Tapar

Role: PRINCIPAL_INVESTIGATOR

Gaziosmanpasa University

Locations

Gaziosmanpasa University

Tokat Province, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 36261200 (View on PubMed)

Other Identifiers

20-KAEK-076

Identifier Type: -

Identifier Source: org_study_id