AnalgesiaNCT05104203
TLIP Block Versus Modified TLIP Block for Posterior Decompression and Stabilization Surgery
A study testing Thoracolumbar Interfascial Plane block and Modified Thorcolumbar Interfascial Plane block in people with Analgesia and Surgical Procedure, Unspecified, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This study aimed to compare the analgesia effectivity of TLIP and modified TLIP block in Posterior Lumbar Decompression and Stabilization Surgery Perioperatively. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesia, Surgical Procedure, Unspecified
- What is being tested?
- Thoracolumbar Interfascial Plane block and Modified Thorcolumbar Interfascial Plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteIndonesia
- Study dates
- 21 Jan 2021to 28 Sep 2021
- 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
- Patients undergo thoracolumbar Decompression and Stabilization Surgery
- Age between 18-65 years old
- BMI >18,5 kg.m2, and BMI< 30 kg/m2
- ASA 1-3
- No contraindications for the patients to do the Block, and the patients agree and signed the informed consent before the procedure was done
Who cannot join
- Obese patient, with BMI>30 kg.m2
- Alergic to local anesthetics
- Underweight patient with BMI <18,5 kg/m2"
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Cental National Hospital
Jakarta, DKI Jakarta, 10430
About this study
Official title: Perioperative Analgesia Efectivity of Thoracolumbar Interfascial Plane Block Compared Modified Thoracolumbar Interfascial Plane Block in Posterior Lumbal Decompression and Stabilization: Research in Intraoperative Hemodynamic and qNox and Total Morfin Comsumption and Postoperative IL-6 Concentration
This study aimed to compare the analgesia effectivity of TLIP and modified TLIP block in Posterior Lumbar Decompression and Stabilization Surgery Perioperatively.
Read the detailed description
This study aimed to compare the analgesia effectivity of TLIP and modified TLIP block in Posterior Lumbar Decompression and Stabilization Surgery. Intraoperatively, total fentanyl consumption, hemodynamic, and mean qNox Score was recorded. And Postoperatively, the patient was given the PCA, and total morphine consumption was assessed.
- Conditions
- Analgesia, Surgical Procedure, Unspecified
- Being tested
- Thoracolumbar Interfascial Plane block, Modified Thorcolumbar Interfascial Plane block
- Keywords
- Erector Spinae Plane Block, opioid consumption, numerical rating scale, Interleukin 10, Interleukin 6, Thoracolumbal Interfascial Plane Block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracolumbar Interfascial Plane blockProcedure or surgery
Interfascial block done by injection between m. multifidus and m. longissimus
Modified Thorcolumbar Interfascial Plane blockProcedure or surgery
Injection of local anesthetics between m. longissimus and m. illiocostalis
| Study group | Role | What they receive |
|---|---|---|
| Thoracolumbar Interfascial Plane block | Active comparator | Patient will receive Thoracolumbar Interfascial Plane block Receives: Procedure: Thoracolumbar Interfascial Plane block; Procedure: Modified Thorcolumbar Interfascial Plane block |
| Modified Thoracolumbar Interfascial Plane block | Experimental | Patient will receive modified Thoracolumbar Interfascial Plane Block Receives: Procedure: Thoracolumbar Interfascial Plane block; Procedure: Modified Thorcolumbar Interfascial Plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic
Stability of Hemodynamics that needs the fentanyl addition
Measured: approximately 15 minutes within surgery
Secondary outcomes (1)
qNox Score
qNox score were taken before induction of anesthesia, 15, 30 and 45 minutes after the block done. the mean of 15,30 and 45 minutes qNox score was assesed
Measured: before induction of anesthesia, 15, 30, 45 minutes after the block was done.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start21 Jan 2021
- Primary completion3 Mar 2021
- Study completion28 Sep 2021
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
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
- NCT05104203
- Sponsor's protocol ID
- IndonesiaUAnes111
- Status last verified
- Oct 2021
- First submitted
- 21 Jul 2021
- Last updated
- 2 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Analgesia Efectivity of Thoracolumbar Interfascial Plane Block Compared Modified Thoracolumbar Interfascial Plane Block in Posterior Lumbal Decompression and Stabilization: Research in Intraoperative Hemodynamic and qNox and Total Morfin Comsumption and Postoperative IL-6 Concentration
- ClinicalTrials.gov ID
- NCT05104203
- Acronym / sponsor ID
- IndonesiaUAnes111
- Conditions
- Analgesia, Surgical Procedure, Unspecified
- Keywords
- Erector Spinae Plane Block, opioid consumption, numerical rating scale, Interleukin 10, Interleukin 6, Thoracolumbal Interfascial Plane Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 3 Mar 2021 (actual)
- Study completion
- 28 Sep 2021 (actual)
- First posted
- 2 Nov 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 compare the analgesia effectivity of TLIP and modified TLIP block in Posterior Lumbar Decompression and Stabilization Surgery Perioperatively.
Detailed description
This study aimed to compare the analgesia effectivity of TLIP and modified TLIP block in Posterior Lumbar Decompression and Stabilization Surgery. Intraoperatively, total fentanyl consumption, hemodynamic, and mean qNox Score was recorded. And Postoperatively, the patient was given the PCA, and total morphine consumption was assessed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracolumbar Interfascial Plane block | Active comparator | Procedure: Thoracolumbar Interfascial Plane block, Procedure: Modified Thorcolumbar Interfascial Plane blockPatient will receive Thoracolumbar Interfascial Plane block |
| Modified Thoracolumbar Interfascial Plane block | Experimental | Procedure: Thoracolumbar Interfascial Plane block, Procedure: Modified Thorcolumbar Interfascial Plane blockPatient will receive modified Thoracolumbar Interfascial Plane Block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergo thoracolumbar Decompression and Stabilization Surgery
- Age between 18-65 years old
- BMI >18,5 kg.m2, and BMI< 30 kg/m2
- ASA 1-3
- No contraindications for the patients to do the Block, and the patients agree and signed the informed consent before the procedure was done
Key exclusion criteria (3 listed)
- Obese patient, with BMI>30 kg.m2
- Alergic to local anesthetics
- Underweight patient with BMI <18,5 kg/m2"
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 Interfascial Plane blockInterfascial block done by injection between m. multifidus and m. longissimus | Procedure or surgery | Modified Thoracolumbar Interfascial Plane block, Thoracolumbar Interfascial Plane block |
| Modified Thorcolumbar Interfascial Plane blockInjection of local anesthetics between m. longissimus and m. illiocostalis | Procedure or surgery | Modified Thoracolumbar Interfascial Plane block, Thoracolumbar Interfascial Plane block |
Primary outcome
Hemodynamic
Time frame: approximately 15 minutes within surgery
Stability of Hemodynamics that needs the fentanyl addition
1 secondary outcome
qNox Score
Time frame: before induction of anesthesia, 15, 30, 45 minutes after the block was done.
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 2 Nov 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Interfascial Plane block and Modified Thorcolumbar Interfascial Plane block in people with Analgesia and Surgical Procedure, Unspecified, 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 5 inclusion and 3 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 2 Nov 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?
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?
Hemodynamic (time frame: approximately 15 minutes within surgery). 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 2 Nov 2021.