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

Primary Purpose

Lumbar Disc Herniation, Lumbar Discogenic Pain, Lumbar Spinal Stenosis

Status
Recruiting
Phase
Not Applicable
Locations
Ukraine
Study Type
Interventional
Intervention
regional anesthesia
Sponsored by
Anesthesia Research Group UA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Disc Herniation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • back surgery

Exclusion Criteria:

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

Sites / Locations

  • Anesthesia department Medical Network DobrobutRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

General anesthesia

Combined anesthesia: general anesthesia and Erector spinae plane block (ESP block)

Combined anesthesia: General anesthesia and Thoraco-lumbar interfacial plane block (TLIP block)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

A Visual Analogue Scale (numerical rating scale (NRS)
minimum 0 ( no pain), maximum 10 (the worst pain ever)
A Visual Analogue Scale (numerical rating scale (NRS)
minimum 0 ( no pain), maximum 10 (the worst pain ever)
A Visual Analogue Scale (numerical rating scale (NRS)
minimum 0 ( no pain), maximum 10 (the worst pain ever)
A Visual Analogue Scale (numerical rating scale (NRS)
minimum 0 ( no pain), maximum 10 (the worst pain ever)

Secondary Outcome Measures

A Visual Analogue Scale (numerical rating scale (NRS)
minimum 0 ( no pain), maximum 10 (the worst pain ever)
A Visual Analogue Scale (numerical rating scale (NRS)
minimum 0 ( no pain), maximum 10 (the worst pain ever)

Full Information

First Posted
June 17, 2022
Last Updated
March 30, 2023
Sponsor
Anesthesia Research Group UA
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1. Study Identification

Unique Protocol Identification Number
NCT05447780
Brief Title
Comparing General Anesthesia, General Anesthesia With ESP Block or TLIP Block in Patients Undergoing Lumbar Surgeries
Official Title
Comparing the General Anesthesia, the General Anesthesia With the ESP Block or TLIP Block in the Patients Undergoing Lumbar Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 18, 2022 (Actual)
Primary Completion Date
September 20, 2023 (Anticipated)
Study Completion Date
April 18, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Anesthesia Research Group UA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation, Lumbar Discogenic Pain, Lumbar Spinal Stenosis, Failed Back Surgery Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
General anesthesia
Arm Type
Experimental
Arm Description
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.
Arm Title
Combined anesthesia: general anesthesia and Erector spinae plane block (ESP block)
Arm Type
Experimental
Arm Description
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.
Arm Title
Combined anesthesia: General anesthesia and Thoraco-lumbar interfacial plane block (TLIP block)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
regional anesthesia
Intervention Description
regional anesthesia in lumbar surgery, TLIP block in spinal surgery, ESP block in spinal surgery
Primary Outcome Measure Information:
Title
A Visual Analogue Scale (numerical rating scale (NRS)
Description
minimum 0 ( no pain), maximum 10 (the worst pain ever)
Time Frame
2 hours after surgery
Title
A Visual Analogue Scale (numerical rating scale (NRS)
Description
minimum 0 ( no pain), maximum 10 (the worst pain ever)
Time Frame
6 hours after surgery
Title
A Visual Analogue Scale (numerical rating scale (NRS)
Description
minimum 0 ( no pain), maximum 10 (the worst pain ever)
Time Frame
24 hour after surgery
Title
A Visual Analogue Scale (numerical rating scale (NRS)
Description
minimum 0 ( no pain), maximum 10 (the worst pain ever)
Time Frame
48 hour after surgery
Secondary Outcome Measure Information:
Title
A Visual Analogue Scale (numerical rating scale (NRS)
Description
minimum 0 ( no pain), maximum 10 (the worst pain ever)
Time Frame
1 month after surgery
Title
A Visual Analogue Scale (numerical rating scale (NRS)
Description
minimum 0 ( no pain), maximum 10 (the worst pain ever)
Time Frame
3 month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: back surgery Exclusion Criteria: contraindications to the regional method of analgesia, patient refusal, patients with diabetes mellitus mental illness pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yelyzaveta Plechysta, MD
Phone
+380636494490
Email
plechysta.y@dobrobut.ua
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yelyzaveta Plechystaya, MD
Organizational Affiliation
chief of the anesthesia department
Official's Role
Study Chair
Facility Information:
Facility Name
Anesthesia department Medical Network Dobrobut
City
Kyiv
ZIP/Postal Code
01000
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yelyzaveta Plechysta, MD
Phone
+380636494490
Email
plechysta.y@dobrobut.ua
First Name & Middle Initial & Last Name & Degree
Terentev Oleksandr, MD
Phone
+380973875200

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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