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

Primary Purpose

Analgesia, Spine Fusion

Status
Completed
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
TLIP Block For Perioperative Analgesia In Patients With Lumbar Spine Fusion Surgery
ESP Block For Perioperative Analgesia In Patients With Lumbar Spine Fusion Surgery
Lidocaine injection
Sponsored by
Hanoi Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Analgesia focused on measuring perioperation, Thoracolumbar interfasial plane, erector spine plane, ultrasound-guided analgesia, patient-controlled analgesia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hanoi Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

TLIP Group

ESP Group

Control Group

Arm Description

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

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.

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

Outcomes

Primary Outcome Measures

The blockade area of TLIP block and ESP block methods
Assessing sensory blockade area, according to the pinprick test
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.
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.
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.
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').
Side effects
Rate of vomitting/nausea, itchy, urinary retention, respiratory failure, circulatory failure postoperative of all groups.

Secondary Outcome Measures

Full Information

First Posted
September 26, 2023
Last Updated
October 9, 2023
Sponsor
Hanoi Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT06082245
Brief Title
TLIP Block and ESP Block For Perioperative Analgesia In Patients With Lumbar Spine Fusion Surgery
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
October 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanoi Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia, Spine Fusion
Keywords
perioperation, Thoracolumbar interfasial plane, erector spine plane, ultrasound-guided analgesia, patient-controlled analgesia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
TLIP block group, ESP block group and control group
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TLIP Group
Arm Type
Active Comparator
Arm Description
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
Arm Title
ESP Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Group
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
TLIP Block For Perioperative Analgesia In Patients With Lumbar Spine Fusion Surgery
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
ESP Block For Perioperative Analgesia In Patients With Lumbar Spine Fusion Surgery
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Lidocaine injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
The blockade area of TLIP block and ESP block methods
Description
Assessing sensory blockade area, according to the pinprick test
Time Frame
after 20 minutes of block
Title
The perioperative effectiveness of TLIP block and ESP block methods (aspect 1)
Description
Evaluating pain relief effectiveness during surgery by total amount of fentanyl used during surgery.
Time Frame
up to the end of surgery
Title
The perioperative effectiveness of TLIP block and ESP block methods (aspect 2)
Description
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.
Time Frame
up to the end of surgery
Title
The perioperative effectiveness of TLIP block and ESP block methods (aspect 1)
Description
Evaluating pain relief effectiveness after surgery by total dose of morphine in 12 hours and 24 hours after surgery.
Time Frame
up to 24 hours after extubation
Title
The perioperative effectiveness of TLIP block and ESP block methods (aspect 2)
Description
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').
Time Frame
up to 24 hours after extubation
Title
Side effects
Description
Rate of vomitting/nausea, itchy, urinary retention, respiratory failure, circulatory failure postoperative of all groups.
Time Frame
up to 24 hours after extubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tu Nguyen, Professor
Organizational Affiliation
Hanoi Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Hanoi Medical University
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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