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

Not Applicable

Recruiting

• Conditions: Lumbar Spinal Stenosis; Lumbar Disc Herniation; Lumbar Discogenic Pain; Failed Back Surgery Syndrome
• Interventions: Procedure: regional anesthesia

• Registration Number: NCT05447780
• Lead Sponsor: Anesthesia Research Group UA

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-18
• Study First Submitted: 2022-06-17
• Study First Submitted QC: 2022-07-06
• Study First Posted: 2022-07-07
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-18
• Primary Completion: 2024-12-20
• Study Completion: 2025-12-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• back surgery

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General anesthesia	regional 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.
Combined anesthesia: General anesthesia and Thoraco-lumbar interfacial plane block (TLIP block)	regional anesthesia	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.
Combined anesthesia: general anesthesia and Erector spinae plane block (ESP block)	regional anesthesia	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
A Visual Analogue Scale (numerical rating scale (NRS)	3 month after surgery	minimum 0 ( no pain), maximum 10 (the worst pain ever)

Trial Locations

Locations (1)

Anesthesia department Medical Network Dobrobut; 🇺🇦 Kyiv, Ukraine