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

Study Overview
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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.

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

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

Intervention / Treatment
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* Procedure: regional anesthesia


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: General anesthesia<br>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<br>* regional anesthesia in lumbar surgery, TLIP block in spinal surgery, ESP block in spinal surgery<br>|
| Experimental: Combined anesthesia: general anesthesia and Erector spinae plane block (ESP block)<br>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<br>* regional anesthesia in lumbar surgery, TLIP block in spinal surgery, ESP block in spinal surgery<br>|
| Experimental: Combined anesthesia: General anesthesia and Thoraco-lumbar interfacial plane block (TLIP block)<br>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<br>* regional anesthesia in lumbar surgery, TLIP block in spinal surgery, ESP block in spinal surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A Visual Analogue Scale (numerical rating scale (NRS) | minimum 0 ( no pain), maximum 10 (the worst pain ever) | 1 month after surgery | 
| A Visual Analogue Scale (numerical rating scale (NRS) | minimum 0 ( no pain), maximum 10 (the worst pain ever) | 3 month after surgery |