TLIP Block and ESP Block For Perioperative Analgesia In Patients With Lumbar Spine Fusion Surgery

Comparison Perioperative Analgesia Efficacy Between Thoracolumbar Interfascial Plane Block and Erector Spinae Plane Block for Patients With Lumbar Spine Fusion Surgery: A Randomized Controlled Study

Background: Pain relief for lumbar spine surgery is being updated to help improve the quality of post-operative recovery, especially ultrasound-guided pain relief anesthesia methods, including two anesthesia methods. Thoracolumbar interfascial plane block (TLIP block) and erector spinae plane block (ESP block) are increasingly commonly applied. Objective: compare the pain relief effectiveness of TLIP block with ESP block for lumbar spine surgery.

Methods: Randomized prospective intervention study conducted at Hanoi Medical University Hospital from October 2021 to October 2022 including 100 lumbar spine surgery patients randomly divided into three groups: group control, TLIP group and ESP group. Outcomes regarding perioperative pain score (ANIm, VAS), the effectiveness of 2 ultrasound-guided methods, the complications and the side effects were recorded.

Study Overview

• Status: Completed
• Conditions: Analgesia; Spine Fusion
• Intervention / Treatment: Procedure: TLIP Block For Perioperative Analgesia In Patients With Lumbar Spine Fusion Surgery; Procedure: ESP Block For Perioperative Analgesia In Patients With Lumbar Spine Fusion Surgery; Procedure: Lidocaine injection

Detailed Description

• All research patients were divided into 3 groups by random drawing: control group, TLIP group and ESP group.
• TLIP group: patients were anesthetized before surgery using TLIP lumbar block (L3) under ultrasound with 20ml of ropivacaine 0.25% anesthetic on each side. After that, the patient was given endotracheal anesthesia for surgery.
• ESP group: patients were anesthetized before surgery with lumbar (L3) ESP block method under ultrasound with 20ml of Ropivacaine 0.25% anesthetic on each side. After that, the patient was given endotracheal anesthesia for surgery.
• Control group: patients received regular endotracheal anesthesia, then the incision was anesthetized with 15ml of 1% lidocaine mixed with 1/200,000 adrenaline on each side before surgery.

• Anesthesia and monitoring process: all patients in all 3 groups were anesthetized using general anesthesia:

  • Install monitoring to monitor pulse parameters, blood pressure, SpO2, EtCO2.
  • Install an Analgesia Nociception Index (ANI) meter and monitor the ANI index continuously during surgery. Monitor ANI monitor V2 during surgery, maintain ANIm within the range of 50-70.
  • Induction of anesthesia: fentanyl 2mcg/kg slow intravenous injection, wait 3 minutes then inject propofol 2-3mg/kg, rocuronium 0.6mg/kg (when eyelid reflex is lost). Proceed with endotracheal intubation and artificial ventilation at a frequency of 12 times/minute, Vt = 6-8ml/kg, FiO2 50%, I:E = 1:2, PEEP = 5cmH2O, EtCO2 = 35-45mmHg, sevoflurane Install until MAC reaches 0.8-1.
  • Maintain anesthesia with sevofluran, maintain 1 MAC.
  • Using fentanyl during surgery: when ANIm index is less than 50: 50mcg fentanyl bolus, repeat after 5 minutes until ANIm greater than 50. Record the amount of fentanyl used during surgery. Record the ANIm index at the time of the study: when skin incision (T0) and every 10 minutes until the end of surgery.
  • Release of anesthesia: Patients are extubated when they meet the criteria: awake, following orders, breathing rate 12-20 times/minute, SpO2 > 95% with FiO2 ≤ 40%, Vt > 5ml/kg, EtCO2 < 45 mmHg , good cough and swallow reflex and TOF ≥ 90%. After extubation, monitor the patient, record pulse index, blood pressure and VAS score and transfer the patient to the hospital room if it reaches 10/10 points according to Aldrete.
• Pain relief: both groups received paracetamol 1g and ketorolac 30mg at the end of skin closure and every 8 hours thereafter. When the patient has postoperative pain (VAS score ≥ 4), they are titrated with intravenous morphine 1mg/time every 10 minutes until reaching a VAS score < 4. At the same time, an intravenous morphine pain relief machine is installed. Patient controlled analgesia (PCA) with bolus setting 1ml = 1mg, lockout time 10 minutes, maximum dose 20mg/4 hours, no background infusion dose.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Hanoi, Vietnam, 100000
    • Hanoi Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) physical status I-III.
• Patients had lumbar spinal fusion surgery.

Exclusion Criteria:

• The patient does not agree to participate in the study.
• Patients with severe chronic diseases: liver failure, kidney failure, heart failure, arrhythmia, neuromuscular disease.
• Patients are using drugs that affect the autonomic nervous system such as beta blockers, parasympathomimetic drugs.
• history of mental disorders, difficulty in communication.
• Patients with acute lumbar spine injury or a history of lumbar spine surgery, injections, abscesses, and lumbar infections.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TLIP Group; Patients were anesthetized before surgery using TLIP lumbar block (L3) under ultrasound with 20ml of ropivacaine 0.25% anesthetic on each side. After that, the patient was given general anesthesia for surgery	Procedure: TLIP Block For Perioperative Analgesia In Patients With Lumbar Spine Fusion Surgery; Patients were placed in a prone position;; ultrasound-guided TLIP block: (1) The transducer was positioned in a transverse midline position at the level of the L3 vertebra. After the identification of the spinous process and interspinous muscles. (2) The probe was moved laterally to identify the multifidus (MF) and longissimus (LG) muscles. (3) the TLIP block was performed under real-time ultrasound guidance using an insulated 100-mm 22G echogenic needle which was inserted in-plane lateral to the medial direction. (4) After negative aspiration, 20-mL 0.25% ropivacaine was injected in each side bilaterally in the interface between the MF and LG muscles.; patients received general anesthesia
Active Comparator: ESP Group; Patients were anesthetized before surgery with lumbar (L3) ESP block method under ultrasound with 20ml of Ropivacaine 0.25% anesthetic on each side. After that, the patient was given general anesthesia for surgery.	Procedure: ESP Block For Perioperative Analgesia In Patients With Lumbar Spine Fusion Surgery; Patients were placed in a prone position;; ultrasound-guided ESP block: (1) The 12th rib was identified in the parasagittal plane, and with probe shifted caudad and medial, the L3 transverse process (TP) was identified. (2) Insulated 100-mm 22G echogenic needle was inserted from cranial to caudal direction. (3) The needle tip was identified between the L2 and L3, and 20 mL of 0.25% ropivacaine was injected in each side bilaterally in ESP.; patients received general anesthesia
Experimental: Control Group; Patients received general anesthesia, then the incision was anesthetized with 15ml of 1% lidocaine mixed with 1/200,000 adrenaline on each side before surgery	Procedure: Lidocaine injection; patients received general anesthesia; the expected incision was anesthetized with 15ml of 1% lidocaine mixed with 1/200,000 adrenaline on each side before surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The blockade area of TLIP block and ESP block methods	Assessing sensory blockade area, according to the pinprick test	after 20 minutes of block
The perioperative effectiveness of TLIP block and ESP block methods (aspect 1)	Evaluating pain relief effectiveness during surgery by total amount of fentanyl used during surgery.	up to the end of surgery
The perioperative effectiveness of TLIP block and ESP block methods (aspect 2)	Evaluating pain relief effectiveness during surgery by Analgesia Nociception Index (ANIm) scores: ANI is based on electrocardiographic data reflecting parasympathetic activity. ANI creates a value from 0 to 100, where a value greater than 50 indicates adequate analgesia (high parasympathetic tone) and a value less than 50 indicates nociception (a high sympathetic tone) and therefore inadequate analgesia.	up to the end of surgery
The perioperative effectiveness of TLIP block and ESP block methods (aspect 1)	Evaluating pain relief effectiveness after surgery by total dose of morphine in 12 hours and 24 hours after surgery.	up to 24 hours after extubation
The perioperative effectiveness of TLIP block and ESP block methods (aspect 2)	Evaluating pain relief effectiveness after surgery by Visual Analogue Scale (VAS) scores at study times within 24 hours after surgery when at rest and on movement (coughing, bending knees). The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').	up to 24 hours after extubation
Side effects	Rate of vomitting/nausea, itchy, urinary retention, respiratory failure, circulatory failure postoperative of all groups.	up to 24 hours after extubation

Collaborators and Investigators

• Sponsor: Hanoi Medical University
• Investigators: Study Director: Tu Nguyen, Professor, Hanoi Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): October 2, 2022

Study Registration Dates

• First Submitted: September 26, 2023
• First Submitted That Met QC Criteria: October 9, 2023
• First Posted (Actual): October 13, 2023

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: patient-controlled analgesia; perioperation; ultrasound-guided analgesia; Thoracolumbar interfasial plane; erector spine plane
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: HMU10.2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The investigators agree that all results and conclusion of this research will be used fully for other researchers
• IPD Sharing Time Frame: from October 2023 to the unidentified time
• IPD Sharing Access Criteria: anesthesiologists, surgeons all over the world
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No