Lumbar Posterior DecompressionNCT04951024
Thoracolumbal Interfascial Plane Block Versus Erector Spinae Plane Block for Lumbar Posterior Decompression Stabilization
A study testing Thoracolumbar interfacial plane (TLIP) Block and Erector Spinae Plane (ESP) Block in people with Lumbar Posterior Decompression, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This study aimed to found out The Comparison Of Perioperative Analgesia Effectiveness Between Thoracolumbal Interfascial Plane Block with Erector Spinae Plane Block In Lumbar Posterior Decompression and Stabilization. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Posterior Decompression
- What is being tested?
- Thoracolumbar interfacial plane (TLIP) Block and Erector Spinae Plane (ESP) Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Mar 2021to 31 Jan 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 - 65 years old
- Patients schedule for elective posterior decompression and stabilization lumbar spine surgery
- ASA I - III
- Decompression and posterior stabilization's patients who didn't caused by infection or abscess
Who cannot join
- Patients who refuse to participate in this study
- Body Mass Index < 18,5 kg/m2 and > 27,0 kg/m2
- Patient with history of chronic opioid
- Patient with coagulation disorder
- Patient with cognitive disorders
- Infection at the injection area
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Cipto Mangunkusumo Cental National Hospital
Jakarta, DKI Jakarta, 10430
Aida R Tantri, Consultant, +628161832487, aidatantri@yahoo.com
About this study
Official title: Comparison of Perioperative Analgesia Effectiveness Between Thoracolumbal Interfascial Plane Block With Erector Spinae Plane Block In Lumbar Posterior Decompression and Stabilization: A Study to Interleukin-6 and Interleukin-10 Plasma Concentration, Pain Scale, Total Opioid Consumption, and Cardiovascular Stability
This study aimed to found out The Comparison Of Perioperative Analgesia Effectiveness Between Thoracolumbal Interfascial Plane Block with Erector Spinae Plane Block In Lumbar Posterior Decompression and Stabilization.
Read the detailed description
This is a double blind randomized controlled trial. Forty subject will be recruited with non-probability consecutive sampling method. Subjects who meet all inclusion criteria and do not have exclusion criteria will be asked to sign the informed consent form before included in this study. Subjects will be randomized into two groups. The first group is the group who will get Bilateral Thoracolumbal Interfascial Plane Block after general anesthesia and the second group will be the group who will get Bilateral Erector Spinae Plane Block after general anesthesia. After surgery, pain scale, time to first morphine dose, total morphine consumption in 24 hours, cardiovascular stability and adverse events will be recorded for both group.
- Conditions
- Lumbar Posterior Decompression
- Being tested
- Thoracolumbar interfacial plane (TLIP) Block, Erector Spinae Plane (ESP) Block
- Keywords
- Thoracolumbal Interfascial Plane Block, Erector Spinae Plane Block, Lumbar Posterior Decompression and Stabilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracolumbar interfacial plane (TLIP) BlockProcedure or surgery
TLIP Block: Bilateral 20 ml 0.25 % Bupivacaine injected between multifidus and longissimus muscle with Ultrasound guidance.
Erector Spinae Plane (ESP) BlockProcedure or surgery
ESP Block: Bilateral 20 ml 0.25 % Bupivacaine injected between the erector spinae muscles and transverse process with Ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| Thoracolumbar interfacial plane (TLIP) Block | Experimental | Thoracolumbar interfacial plane (TLIP) Block will be performed after induction of anesthesia by anesthesiologist who is not part of investigators for this study. Bilateral 20 ml 0.25 % Bupivacaine injected between multifidus and longissimus muscle with Ultrasound guidance. Receives: Procedure: Thoracolumbar interfacial plane (TLIP) Block; Procedure: Erector Spinae Plane (ESP) Block |
| Erector Spinae Plane (ESP) Block | Active comparator | Erector Spinae Plane (ESP) Block will be performed after induction of anesthesia by anesthesiologist who is not part of investigators for this study. Bilateral 20 ml 0.25 % Bupivacaine injected between the erector spinae muscles and transverse process with Ultrasound guidance Receives: Procedure: Thoracolumbar interfacial plane (TLIP) Block; Procedure: Erector Spinae Plane (ESP) Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Interleukin-6 and Interleukin-10 at 6 hours after Lumbar Posterior Decompression and Stabilization
Measure by ELISA
Measured: Before surgery and 6 hours after surgery
Secondary outcomes (1)
investigators will record total morphine dose needed in 24 hours
investigators will record time to first morphine dose after surgery
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start1 Mar 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lumbar Posterior DecompressionStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aida Rosita Tantri, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04951024
- Sponsor's protocol ID
- IndonesiaUAnes105
- Status last verified
- Jun 2021
- First submitted
- 26 Jun 2021
- Last updated
- 6 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tantri AR, Rahmi R, Marsaban AHM, Satoto D, Rahyussalim AJ, Sukmono RB. Comparison of postoperative IL-6 and IL-10 levels following Erector Spinae Plane Block (ESPB) and classical Thoracolumbar Interfascial Plane (TLIP) block in a posterior lumbar decompression and stabilization procedure: a randomized controlled trial. BMC Anesthesiol. 2023 Jan 10;23(1):13. doi: 10.1186/s12871-023-01973-w.
PubMed 36624374
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Perioperative Analgesia Effectiveness Between Thoracolumbal Interfascial Plane Block With Erector Spinae Plane Block In Lumbar Posterior Decompression and Stabilization: A Study to Interleukin-6 and Interleukin-10 Plasma Concentration, Pain Scale, Total Opioid Consumption, and Cardiovascular Stability
- ClinicalTrials.gov ID
- NCT04951024
- Acronym / sponsor ID
- IndonesiaUAnes105
- Conditions
- Lumbar Posterior Decompression
- Keywords
- Thoracolumbal Interfascial Plane Block, Erector Spinae Plane Block, Lumbar Posterior Decompression and Stabilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 6 Jul 2021 (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.
This study aimed to found out The Comparison Of Perioperative Analgesia Effectiveness Between Thoracolumbal Interfascial Plane Block with Erector Spinae Plane Block In Lumbar Posterior Decompression and Stabilization.
Detailed description
This is a double blind randomized controlled trial. Forty subject will be recruited with non-probability consecutive sampling method. Subjects who meet all inclusion criteria and do not have exclusion criteria will be asked to sign the informed consent form before included in this study. Subjects will be randomized into two groups. The first group is the group who will get Bilateral Thoracolumbal Interfascial Plane Block after general anesthesia and the second group will be the group who will get Bilateral Erector Spinae Plane Block after general anesthesia. After surgery, pain scale, time to first morphine dose, total morphine consumption in 24 hours, cardiovascular stability and adverse events will be recorded for both group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracolumbar interfacial plane (TLIP) Block | Experimental | Procedure: Thoracolumbar interfacial plane (TLIP) Block, Procedure: Erector Spinae Plane (ESP) BlockThoracolumbar interfacial plane (TLIP) Block will be performed after induction of anesthesia by anesthesiologist who is not part of investigators for this study. Bilateral 20 ml 0.25 % Bupivacaine injected between multifidus and longissimus muscle with Ultrasound guidance. |
| Erector Spinae Plane (ESP) Block | Active comparator | Procedure: Thoracolumbar interfacial plane (TLIP) Block, Procedure: Erector Spinae Plane (ESP) BlockErector Spinae Plane (ESP) Block will be performed after induction of anesthesia by anesthesiologist who is not part of investigators for this study. Bilateral 20 ml 0.25 % Bupivacaine injected between the erector spinae muscles and transverse process with Ultrasound guidance |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 - 65 years old
- Patients schedule for elective posterior decompression and stabilization lumbar spine surgery
- ASA I - III
- Decompression and posterior stabilization's patients who didn't caused by infection or abscess
Key exclusion criteria (6 listed)
- Patients who refuse to participate in this study
- Body Mass Index < 18,5 kg/m2 and > 27,0 kg/m2
- Patient with history of chronic opioid
- Patient with coagulation disorder
- Patient with cognitive disorders
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 |
|---|---|---|
| Thoracolumbar interfacial plane (TLIP) BlockTLIP Block: Bilateral 20 ml 0.25 % Bupivacaine injected between multifidus and longissimus muscle with Ultrasound guidance. | Procedure or surgery | Erector Spinae Plane (ESP) Block, Thoracolumbar interfacial plane (TLIP) Block |
| Erector Spinae Plane (ESP) BlockESP Block: Bilateral 20 ml 0.25 % Bupivacaine injected between the erector spinae muscles and transverse process with Ultrasound guidance. | Procedure or surgery | Erector Spinae Plane (ESP) Block, Thoracolumbar interfacial plane (TLIP) Block |
Primary outcome
Change from baseline Interleukin-6 and Interleukin-10 at 6 hours after Lumbar Posterior Decompression and Stabilization
Time frame: Before surgery and 6 hours after surgery
Measure by ELISA
1 secondary outcome
investigators will record total morphine dose needed in 24 hours
Time frame: 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2021.
- Derived from this study: PubMed 36624374Tantri AR, Rahmi R, Marsaban AHM, Satoto D, Rahyussalim AJ, Sukmono RB. Comparison of postoperative IL-6 and IL-10 levels following Erector Spinae Plane Block (ESPB) and classical Thoracolumbar Interfascial Plane (TLIP) block in a posterior lumbar decompression and stabilization procedure: a randomized controlled trial. BMC Anesthesiol. 2023 Jan 10;23(1):13. doi: 10.1186/s12871-023-01973-w.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracolumbar interfacial plane (TLIP) Block and Erector Spinae Plane (ESP) Block in people with Lumbar Posterior Decompression, run by Universitas Indonesia at 1 site in Indonesia.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 6 Jul 2021. 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 Indonesia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aida Rosita R Tantri (0213143336, aidatantri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Interleukin-6 and Interleukin-10 at 6 hours after Lumbar Posterior Decompression and Stabilization (time frame: Before surgery and 6 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04951024, which also lists 1 linked publication.
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 6 Jul 2021.