Spine SurgeriesTLIPNCT03060681
Thoracolumber Oterfacial Plane Block for Spine Surgery
A study testing Bupivacaine 0.5% injected in the thoraco-lumber inetrfacial plane block in people with Spine Surgeries, run by Mansoura University at 1 site in Egypt.
Trial summary
The most commonly used technique to anesthetize patients scheduled for thoracic or lumbar spine surgery is general anesthesia. Analgesic techniques vary from the use of neuraxial techniques like epidural, intrathecal, or caudal analgesia, nerve root infiltration to the use of systemic opioids, Paracetamol… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Spine Surgeries
- What is being tested?
- Bupivacaine 0.5% injected in the thoraco-lumber inetrfacial plane block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2017to 20 Feb 2018
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients scheduled for Spine surgery.
Who cannot join
- Spine deformities, redo surgeries, patients refusing being enrolled in the study, and patients with a bleeding tendency (INR˃ 1.4 and or Platelet count ≤ 150 X103/ µl) will be excluded.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura university
Al Mansurah, Dakahlia Governorate
Amr Yassen, ameyassen@hotmail.com
About this study
Official title: Thoracolumbar Interfacial Plane Block for Analgesia After Spine Surgery
The most commonly used technique to anesthetize patients scheduled for thoracic or lumbar spine surgery is general anesthesia. Analgesic techniques vary from the use of neuraxial techniques like epidural, intrathecal, or caudal analgesia, nerve root infiltration to the use of systemic opioids, Paracetamol, non-steroidal anti-inflammatory drugs (NSAID), steroids and gabapentinoids .
In 2015, a promising regional analgesia technique was reported, that targets the dorsal, rather than ventral, rami of the thoracolumbar nerves as they pass through the paraspinal musculature, and called this a thoracolumbar interfacial plane block (TLIP).
- Conditions
- Spine Surgeries
- Being tested
- Bupivacaine 0.5% injected in the thoraco-lumber inetrfacial plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine 0.5% injected in the thoraco-lumber inetrfacial plane blockDrug
After attaching basic monitors (ECG, SpO2, NIBP), the patient will take the prone position. Using the superficial probe of the ultrasound machine, the probe will be placed in transversally in midline position at selected level. The spinous process and interspinalis muscles will be identified. The probe was then moved laterally to identify the mulifidus muscle (MF) and the longissimus muscles (LG) where the local anesthetic will be injected. The needle will be advanced under real-time in-plane ultrasound guidance till it reaches the interface between the two muscles then a 1-2 ml of saline will be inserted to confirm needle site. 15 ml of bupivacaine 0.25 will be injected each side.
| Study group | Role | What they receive |
|---|---|---|
| T group | Experimental | Ultrasound guided Bilateral TLIP Block will be performed 15 minute before the start of surgery Using 15 ml of bupivacaine 0.25 for each side. Receives: Drug: Bupivacaine 0.5% injected in the thoraco-lumber inetrfacial plane block |
| C group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative morphine consumption in milligrams
morphine consumption (mg)required to keep visual anlohue scale below 4 in the 1st 24 hours after surgery
Measured: for the 1st 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 posted23 Feb 2017
- Study start15 Feb 2017
- Primary completion20 Feb 2018 (estimated)
- Study completion20 Feb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine SurgeriesStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AlRefaey Kandeel, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060681
- Sponsor's protocol ID
- TLIP
- Acronym
- TLIP
- Status last verified
- Mar 2017
- First submitted
- 11 Feb 2017
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracolumbar Interfacial Plane Block for Analgesia After Spine Surgery
- ClinicalTrials.gov ID
- NCT03060681
- Acronym / sponsor ID
- TLIP / TLIP
- Conditions
- Spine Surgeries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 20 Feb 2018 (estimated)
- Study completion
- 20 Feb 2018 (estimated)
- First posted
- 23 Feb 2017 (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.
The most commonly used technique to anesthetize patients scheduled for thoracic or lumbar spine surgery is general anesthesia. Analgesic techniques vary from the use of neuraxial techniques like epidural, intrathecal, or caudal analgesia, nerve root infiltration to the use of systemic opioids, Paracetamol, non-steroidal anti-inflammatory drugs (NSAID), steroids and gabapentinoids .
In 2015, a promising regional analgesia technique was reported, that targets the dorsal, rather than ventral, rami of the thoracolumbar nerves as they pass through the paraspinal musculature, and called this a thoracolumbar interfacial plane block (TLIP).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T group | Experimental | Drug: Bupivacaine 0.5% injected in the thoraco-lumber inetrfacial plane blockUltrasound guided Bilateral TLIP Block will be performed 15 minute before the start of surgery Using 15 ml of bupivacaine 0.25 for each side. |
| C group | No intervention | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients scheduled for Spine surgery.
Key exclusion criteria (1 listed)
- Spine deformities, redo surgeries, patients refusing being enrolled in the study, and patients with a bleeding tendency (INR˃ 1.4 and or Platelet count ≤ 150 X103/ µl) will be excluded.
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 |
|---|---|---|
| Bupivacaine 0.5% injected in the thoraco-lumber inetrfacial plane blockAfter attaching basic monitors (ECG, SpO2, NIBP), the patient will take the prone position. Using the superficial probe of the ultrasound machine, the probe will be placed in transversally in midline position at selected level. The spinous process and interspinalis muscles will be identified. The probe was then moved laterally to identify the mulifidus muscle (MF) and the longissimus muscles (LG) where the local anesthetic will be injected. The needle will be advanced under real-time in-plane ultrasound guidance till it reaches the interface between the two muscles then a 1-2 ml of saline will be inserted to confirm needle site. 15 ml of bupivacaine 0.25 will be injected each side. | Drug | T group |
Primary outcome
postoperative morphine consumption in milligrams
Time frame: for the 1st 24 hours after surgery
morphine consumption (mg)required to keep visual anlohue scale below 4 in the 1st 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 9 Mar 2017.
- 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 Bupivacaine 0.5% injected in the thoraco-lumber inetrfacial plane block in people with Spine Surgeries, run by Mansoura University at 1 site in Egypt.
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 1 inclusion and 1 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 9 Mar 2017. 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 Egypt. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative morphine consumption in milligrams (time frame: for the 1st 24 hours after 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 9 Mar 2017.