AnalgesiaNCT06082245
TLIP Block and ESP Block For Perioperative Analgesia In Patients With Lumbar Spine Fusion Surgery
A study testing TLIP Block For Perioperative Analgesia In Patients With Lumbar Spine Fusion Surgery, ESP Block For Perioperative Analgesia In Patients With Lumbar Spine Fusion Surgery and Lidocaine injection in people with Analgesia and Spine Fusion, run by Hanoi Medical University at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Analgesia, Spine Fusion
- What is being tested?
- TLIP Block For Perioperative Analgesia In Patients With Lumbar Spine Fusion Surgery, ESP Block For Perioperative Analgesia In Patients With Lumbar Spine Fusion Surgery and Lidocaine injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Oct 2021to 2 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I-III.
- Patients had lumbar spinal fusion surgery.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Analgesia, Spine Fusion
- Being tested
- 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
- Keywords
- perioperation, Thoracolumbar interfasial plane, erector spine plane, ultrasound-guided analgesia, patient-controlled analgesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLIP Block For Perioperative Analgesia In Patients With Lumbar Spine Fusion SurgeryProcedure or 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
ESP Block For Perioperative Analgesia In Patients With Lumbar Spine Fusion SurgeryProcedure or 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
Lidocaine injectionProcedure or surgery
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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 Receives: Procedure: Lidocaine injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The blockade area of TLIP block and ESP block methods
Assessing sensory blockade area, according to the pinprick test
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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').
Measured: up to 24 hours after extubation
Side effects
Rate of vomitting/nausea, itchy, urinary retention, respiratory failure, circulatory failure postoperative of all groups.
Measured: up to 24 hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start1 Oct 2021
- Primary completion30 Sep 2022
- Study completion2 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- TLIP block group, ESP block group and control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanoi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tu Nguyen, Professor, Study director, Hanoi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06082245
- Sponsor's protocol ID
- HMU10.2023
- Status last verified
- Sep 2023
- First submitted
- 26 Sep 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators agree that all results and conclusion of this research will be used fully for other researchers
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06082245
- Acronym / sponsor ID
- HMU10.2023
- Conditions
- Analgesia, Spine Fusion
- Keywords
- perioperation, Thoracolumbar interfasial plane, erector spine plane, ultrasound-guided analgesia, patient-controlled analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hanoi Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 2 Oct 2022 (actual)
- First posted
- 13 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- TLIP block group, ESP block group and control group
| Arm | Type | Receives |
|---|---|---|
| TLIP Group | Active comparator | Procedure: TLIP Block For Perioperative Analgesia In Patients With Lumbar Spine Fusion SurgeryPatients 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 |
| ESP Group | Active comparator | Procedure: ESP Block For Perioperative Analgesia In Patients With Lumbar Spine Fusion SurgeryPatients 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. |
| Control Group | Experimental | Procedure: Lidocaine injectionPatients received general anesthesia, then the incision was anesthetized with 15ml of 1% lidocaine mixed with 1/200,000 adrenaline on each side before surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status I-III.
- Patients had lumbar spinal fusion surgery.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | TLIP Group |
| 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 | Procedure or surgery | ESP Group |
| 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. | Procedure or surgery | Control Group |
Primary outcome
The blockade area of TLIP block and ESP block methods
Time frame: after 20 minutes of block
Assessing sensory blockade area, according to the pinprick test
The perioperative effectiveness of TLIP block and ESP block methods (aspect 1)
Time frame: up to the end of surgery
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)
Time frame: up to the end of surgery
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)
Time frame: up to 24 hours after extubation
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)
Time frame: up to 24 hours after extubation
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
Time frame: up to 24 hours after extubation
Rate of vomitting/nausea, itchy, urinary retention, respiratory failure, circulatory failure postoperative of all groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Individual participant dataSharing planned: Yes. The investigators agree that all results and conclusion of this research will be used fully for other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tu Nguyen, Professor study director
Hanoi Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TLIP Block For Perioperative Analgesia In Patients With Lumbar Spine Fusion Surgery, ESP Block For Perioperative Analgesia In Patients With Lumbar Spine Fusion Surgery and Lidocaine injection in people with Analgesia and Spine Fusion, run by Hanoi Medical University at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The blockade area of TLIP block and ESP block methods (time frame: after 20 minutes of block). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2023; AzTrials last refreshed its copy on 7 Nov 2026.