NCT05447780

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 7, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2025

Completed
Last Updated

March 18, 2024

Status Verified

March 1, 2024

Enrollment Period

2.7 years

First QC Date

June 17, 2022

Last Update Submit

March 15, 2024

Conditions

Lumbar Disc HerniationLumbar Discogenic PainLumbar Spinal StenosisFailed Back Surgery Syndrome

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • A Visual Analogue Scale (numerical rating scale (NRS)

    1 month after surgery

  • A Visual Analogue Scale (numerical rating scale (NRS)

    3 month after surgery

Study Arms (3)

General anesthesia

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Interventions

regional anesthesiaPROCEDURE

regional anesthesia in lumbar surgery, TLIP block in spinal surgery, ESP block in spinal surgery

Combined anesthesia: General anesthesia and Thoraco-lumbar interfacial plane block (TLIP block)Combined anesthesia: general anesthesia and Erector spinae plane block (ESP block)General anesthesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • back surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesia department Medical Network Dobrobut

Kyiv, 01000, Ukraine

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc DisplacementSpinal StenosisFailed Back Surgery Syndrome

Interventions

Anesthesia, Conduction

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesBack PainPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Officials

  • Yelyzaveta Plechystaya, MD

    chief of the anesthesia department

    STUDY CHAIR

Central Study Contacts

Yelyzaveta Plechysta, MD

CONTACT

+380636494490plechysta.y@dobrobut.ua

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of the anesthesia department

Study Record Dates

First Submitted

June 17, 2022

First Posted

July 7, 2022

Study Start

April 18, 2022

Primary Completion

December 20, 2024

Study Completion

December 18, 2025

Last Updated

March 18, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

UA(1)