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NCT05447780 Clinical Trial

Comparing General Anesthesia, General Anesthesia With ESP Block or TLIP Block in Patients Undergoing Lumbar Surgeries

Lumbar Spinal Stenosis Clinical Trial

Official title:
Comparing the General Anesthesia, the General Anesthesia With the ESP Block or TLIP Block in the Patients Undergoing Lumbar Surgeries

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05447780
Other study ID # 1718042022
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 18, 2022
Est. completion date December 18, 2025

Study information
Verified date March 2024
Source Anesthesia Research Group UA
Contact Yelyzaveta Plechysta, MD
Phone +380636494490
Email plechysta.y@dobrobut.ua
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The regional methods of anesthesia for the neurosurgical operations of the spine and spinal cord reducing the needs for opioids intra operatively and reducing pain in the postoperative period, decrease the numbers of failed back syndrome.

Recruitment information / eligibility
Status Recruiting
Enrollment 450
Est. completion date December 18, 2025
Est. primary completion date December 20, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - back surgery Exclusion Criteria: - contraindications to the regional method of analgesia, - patient refusal, - patients with diabetes mellitus - mental illness - pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• regional anesthesia
regional anesthesia in lumbar surgery, TLIP block in spinal surgery, ESP block in spinal surgery

Locations
Country Name City State
Ukraine Anesthesia department Medical Network Dobrobut Kyiv

Sponsors (1)
Lead Sponsor Collaborator
Anesthesia Research Group UA

Country where clinical trial is conducted

Ukraine, 

Outcome
Type Measure Description Time frame Safety issue
Primary A Visual Analogue Scale (numerical rating scale (NRS) minimum 0 ( no pain), maximum 10 (the worst pain ever) 2 hours after surgery
Primary A Visual Analogue Scale (numerical rating scale (NRS) minimum 0 ( no pain), maximum 10 (the worst pain ever) 6 hours after surgery
Primary A Visual Analogue Scale (numerical rating scale (NRS) minimum 0 ( no pain), maximum 10 (the worst pain ever) 24 hour after surgery
Primary A Visual Analogue Scale (numerical rating scale (NRS) minimum 0 ( no pain), maximum 10 (the worst pain ever) 48 hour after surgery
Secondary A Visual Analogue Scale (numerical rating scale (NRS) minimum 0 ( no pain), maximum 10 (the worst pain ever) 1 month after surgery
Secondary A Visual Analogue Scale (numerical rating scale (NRS) minimum 0 ( no pain), maximum 10 (the worst pain ever) 3 month after surgery
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