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

NCT ID: NCT05447780

Last Updated: 2024-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-18

Study Completion Date

2025-12-18

Brief Summary

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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.

Detailed Description

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Conditions

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Lumbar Disc Herniation Lumbar Discogenic Pain Lumbar Spinal Stenosis Failed Back Surgery Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

regional anesthesia

Intervention Type PROCEDURE

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

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.

Group Type EXPERIMENTAL

regional anesthesia

Intervention Type PROCEDURE

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)

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.

Group Type EXPERIMENTAL

regional anesthesia

Intervention Type PROCEDURE

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

Interventions

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regional anesthesia

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* back surgery

Exclusion Criteria

* contraindications to the regional method of analgesia,
* patient refusal,
* patients with diabetes mellitus
* mental illness
* pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Anesthesia Research Group UA

OTHER

Sponsor Role lead

Responsible Party

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Plechysta Yelyzaveta

Chief of the anesthesia department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yelyzaveta Plechystaya, MD

Role: STUDY_CHAIR

chief of the anesthesia department

Locations

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Anesthesia department Medical Network Dobrobut

Kyiv, , Ukraine

Site Status RECRUITING

Countries

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Ukraine

Central Contacts

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Yelyzaveta Plechysta, MD

Role: CONTACT

+380636494490

Facility Contacts

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Yelyzaveta Plechysta, MD

Role: primary

+380636494490

Terentev Oleksandr, MD

Role: backup

+380973875200

Other Identifiers

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1718042022

Identifier Type: -

Identifier Source: org_study_id

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