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

NCT06082245 | Completed DMC

• 1 other identifier: HMU10.2023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia; Spine Fusion

Keywords

perioperation; Thoracolumbar interfasial plane; erector spine plane; ultrasound-guided analgesia; patient-controlled analgesia

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (3)

TLIP Group

ACTIVE COMPARATOR

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

ESP Group

ACTIVE COMPARATOR

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

Control Group

EXPERIMENTAL

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

Interventions

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

* 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

TLIP Group

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

* 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

ESP Group

Lidocaine injection PROCEDURE

* 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.

Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hanoi Medical University: lead

Study Sites (1)

Hanoi Medical University

Hanoi, 100000, Vietnam

Location

MeSH Terms

Conditions

Agnosia

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Tu Nguyen, Professor

  Hanoi Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: TLIP block group, ESP block group and control group

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 13, 2023
• Study Start: October 1, 2021
• Primary Completion: September 30, 2022
• Study Completion: October 2, 2022
• Last Updated: October 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: from October 2023 to the unidentified time
• Access Criteria: anesthesiologists, surgeons all over the world

Locations

VN (1)