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

Sponsor
Anesthesia Research Group UA (Other)
Overall Status
Recruiting
CT.gov ID
NCT05447780
Collaborator
(none)
450
Enrollment
1
Location
3
Arms
12
Anticipated Duration (Months)
37.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: regional anesthesia
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
450 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparing the General Anesthesia, the General Anesthesia With the ESP Block or TLIP Block in the Patients Undergoing Lumbar Surgeries
Actual Study Start Date :
Apr 18, 2022
Anticipated Primary Completion Date :
Sep 20, 2022
Anticipated Study Completion Date :
Apr 18, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. A Visual Analogue Scale (numerical rating scale (NRS) [2 hours after surgery]

    minimum 0 ( no pain), maximum 10 (the worst pain ever)

  2. A Visual Analogue Scale (numerical rating scale (NRS) [6 hours after surgery]

    minimum 0 ( no pain), maximum 10 (the worst pain ever)

  3. A Visual Analogue Scale (numerical rating scale (NRS) [24 hour after surgery]

    minimum 0 ( no pain), maximum 10 (the worst pain ever)

  4. A Visual Analogue Scale (numerical rating scale (NRS) [48 hour after surgery]

    minimum 0 ( no pain), maximum 10 (the worst pain ever)

Secondary Outcome Measures

  1. A Visual Analogue Scale (numerical rating scale (NRS) [1 month after surgery]

    minimum 0 ( no pain), maximum 10 (the worst pain ever)

  2. A Visual Analogue Scale (numerical rating scale (NRS) [3 month after surgery]

    minimum 0 ( no pain), maximum 10 (the worst pain ever)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • back surgery
Exclusion Criteria:

  • contraindications to the regional method of analgesia,

  • patient refusal,

  • patients with diabetes mellitus

  • mental illness

  • pregnancy

Contacts and Locations

Locations

Site City State Country Postal Code
1 Anesthesia department Medical Network Dobrobut Kyiv Ukraine 01000

Sponsors and Collaborators

  • Anesthesia Research Group UA

Investigators

  • Study Chair: Yelyzaveta Plechystaya, MD, chief of the anesthesia department

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Plechysta Yelyzaveta, Chief of the anesthesia department, Anesthesia Research Group UA
ClinicalTrials.gov Identifier:
NCT05447780
Other Study ID Numbers:
  • 1718042022
First Posted:
Jul 7, 2022
Last Update Posted:
Jul 7, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Spinal Stenosis
Intervertebral Disc Displacement
Failed Back Surgery Syndrome
Anesthetics

Study Results

No Results Posted as of Jul 7, 2022