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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lumbar Disc Herniation; Lumbar Spinal Stenosis; Failed Back Surgery Syndrome; Lumbar Discogenic Pain
• Intervention / Treatment: Procedure: regional anesthesia

• Study Type: Interventional
• Enrollment (Estimated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yelyzaveta Plechysta, MD; Phone Number: +380636494490; Email: plechysta.y@dobrobut.ua

Study Locations

• Ukraine
  • Kyiv, Ukraine, 01000
    • Recruiting
    • Anesthesia department Medical Network Dobrobut
    • Contact: Yelyzaveta Plechysta, MD; Phone Number: +380636494490; Email: plechysta.y@dobrobut.ua
    • Contact: Terentev Oleksandr, MD; Phone Number: +380973875200

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• back surgery

Exclusion Criteria:

• contraindications to the regional method of analgesia,
• patient refusal,
• patients with diabetes mellitus
• mental illness
• pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: General anesthesia; induction: propofol 1.5-2.5 mg\kg IV bolus and fentanyl 1-2 mcg\kg maintenance anesthesia: sevoflurane, doses of the inhalation agent according to bispectral index (BIS) monitor ( target BIS level 40-60) and fentanyl 1-5 mcg\kg\h.	Procedure: regional anesthesia; regional anesthesia in lumbar surgery, TLIP block in spinal surgery, ESP block in spinal surgery
Experimental: Combined anesthesia: general anesthesia and Erector spinae plane block (ESP block); induction: propofol 1.5-2.5 mg\kg IV bolus and fentanyl 1-2 mcg\kg ESP- block with US control with single shot of local anesthetic ( bupivacaine 0.375% or 0.25% 20-30 ml) is performed after induction. maintenance anesthesia: sevoflurane, doses of the inhalation agent according to BIS monitor ( target BIS level 40-60) and fentanyl 0.5-1.5 mcg\kg\h.	Procedure: regional anesthesia; regional anesthesia in lumbar surgery, TLIP block in spinal surgery, ESP block in spinal surgery
Experimental: Combined anesthesia: General anesthesia and Thoraco-lumbar interfacial plane block (TLIP block); induction: propofol 1.5-2.5 mg\kg IV bolus and fentanyl 1-2 mcg\kg TLIP- block with US control with single shot of local anesthetic ( bupivacaine 0.25% 15 ml or mixed bupivacaine 0.25% 7.5 ml and lidocaine 2% 7.5 ml) is performed after induction. maintenance anesthesia: sevoflurane, doses of the inhalation agent according to BIS monitor ( target BIS level 40-60) and fentanyl 0.5-1.5 mcg\kg\h.	Procedure: regional anesthesia; regional anesthesia in lumbar surgery, TLIP block in spinal surgery, ESP block in spinal surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A Visual Analogue Scale (numerical rating scale (NRS)	minimum 0 ( no pain), maximum 10 (the worst pain ever)	2 hours after surgery
A Visual Analogue Scale (numerical rating scale (NRS)	minimum 0 ( no pain), maximum 10 (the worst pain ever)	6 hours after surgery
A Visual Analogue Scale (numerical rating scale (NRS)	minimum 0 ( no pain), maximum 10 (the worst pain ever)	24 hour after surgery
A Visual Analogue Scale (numerical rating scale (NRS)	minimum 0 ( no pain), maximum 10 (the worst pain ever)	48 hour after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A Visual Analogue Scale (numerical rating scale (NRS)	minimum 0 ( no pain), maximum 10 (the worst pain ever)	1 month after surgery
A Visual Analogue Scale (numerical rating scale (NRS)	minimum 0 ( no pain), maximum 10 (the worst pain ever)	3 month after surgery

Collaborators and Investigators

• Sponsor: Anesthesia Research Group UA
• Investigators: Study Chair: Yelyzaveta Plechystaya, MD, chief of the anesthesia department

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2022
• Primary Completion (Estimated): December 20, 2024
• Study Completion (Estimated): December 18, 2025

Study Registration Dates

• First Submitted: June 17, 2022
• First Submitted That Met QC Criteria: July 6, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Back Pain; Intervertebral Disc Displacement; Spinal Stenosis; Failed Back Surgery Syndrome; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 1718042022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No